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Volume 7 • Number 2 • February 2002
Atopic dermatitis (AD) is a chronic itchy, inflammatory skin
disease that usually develops in early childhood and is commonly
seen in individuals with a personal or family history of similar
skin disease or asthma. Persistence of AD has been reported in
60% of adults who had the disease as children.
1
It is notorious for
its recalcitrant and chronically recurrent nature.
1
Along with the
usual therapy of topical steroids, general skin care, and topical
antibiotics there are also systemic methods of treating this
disorder, which have already been well described.
2,3
Because effective medical treatments for this condition are
limited in number, many patients have turned to alternative
therapies
1,4
, including so-called natural products, herbal products
and OTC treatments, many of which remain unproven.
In a questionnaire study of 227 patients with AD, who had used
alternative medicine, the majority stated that their main reason
for trying such treatments was the lack of a satisfactory effect
from the physician provided therapy. They also reported that the
main sources of information about alternative therapies were
people without skin disease, and the media. After using
alternative treatments, the majority of patients reported no
improvement or even aggravation of their skin disorder.
5
Most patients have heard about at least one friend who improved
after receiving a natural treatment. While it may have been the
treatment itself that helped, there may have been other factors as
well, e.g., such treatment providers seem to offer a comfortable
atmosphere for their clients and often allow them to express their
own views of their problems.
3
They may also spend more time
with them than physicians are willing or able to do.
A system of medical practice making use of all measures that
have proven to be of value in the treatment of disease is referred
to as allopathic medicine. Occasionally, some of the
recommended modalities are intended not to replace
conventional medicine, but to complement it. Complementary or
alternative medicine can be classified into herbal therapy
(treatments using plant species), and non-herbal therapies, such
as homeopathy, acupuncture, aromatherapy and more than 10
other modalities.
6
Herbs
Herbs and medications share a common history, as most of our
well-known medications were derived from plants. Herbal
remedies are marketed commonly as pills, capsules, tinctures or
dietary supplements and are largely unregulated. According to
US federal legislation that was enacted in 1994, herbs and other
dietary supplements can be marketed without testing for safety or
effectiveness. Broad and vague claims are allowed, and the US
FDA does not have to approve packaging or sales information
EDITOR-IN-CHIEF: Stuart Maddin ASSOCIATE EDITOR (International): Hugo Degreef, Catholic University, Leuven: ASSOCIATE EDITOR (Canada): Jason Rivers
INTERNET EDITOR: Harvey Lui PUBLICATIONS EDITOR: Penelope Gray-Allan EDITORIAL ADVISORY BOARD: Kenneth A. Arndt, Beth Israel Hospital & Harvard Medical School, Boston;
Wilma Fowler Bergfeld, Cleveland Clinic, Cleveland; Jan D. Bos, University of Amsterdam, Amsterdam; Enno Christophers, Universitäts-Hautklinik, Kiel; Richard L. Dobson, Medical University
of South Carolina, Charleston; Jeffrey S. Dover, Harvard Medical School, Boston; Boni E. Elewski, University of Alabama, Birmingham; Barbara A. Gilchrest, Boston University School of
Medicine, Boston; W. Andrew D. Griffiths, St. Johns Institute of Dermatology, London; Aditya K. Gupta, University of Toronto, Toronto;Vincent C.Y. Ho, University of British Columbia, Vancouver;
Mark Lebwohl, Mount Sinai Medical Center, New York; James J. Leyden, University of Pennsylvania, Philadelphia; Howard I. Maibach, University of California Hospital, San Francisco;
Larry E. Millikan, Tulane University Medical Center, New Orleans; Takeji Nishikawa, Keio University School of Medicine, Tokyo; Constantin E. Orfanos, Freie Universitäts Berlin,
Universitätsklinikum Benjamin Franklin, Berlin; Stephen L. Sacks, Viridae Clinic Sciences, Vancouver; Alan R. Shalita, SUNY Health Sciences Center, Brooklyn; Richard Thomas, Vancouver
General Hospital, Vancouver; Stephen K. Tyring, University of Texas Medical Branch, Galveston; John Voorhees, University of Michigan, Ann Arbor; Klaus Wolff, University of Vienna, Vienna
Alternative Treatments For Atopic Dermatitis:
A Selected Review
R.B. Vender, MD, FRCPC
DermaTrials Research and Department of Medicine, McMaster University, Hamilton, Ontario, Canada
ABSTRACT
Atopic dermatitis (AD) is a chronic itchy, inflammatory skin disease that is extremely difficult to treat. Effective therapeutic agents
are limited in number, and may have long-term toxic side effects. Frustrated by these realities, many patients stop seeking help from
conventional physicians and turn to alternative medical approaches. These can include so-called natural products, herbal products
and over-the-counter (OTC) treatments. Herbs and medications share a common history, as most of our well-known medications
were derived from plants. However, herbal remedies are largely unregulated. Many may have scientific merit and clinical benefit,
but they are still scientifically invalid and inadequately monitored. Dermatologists need information about the effects of herbal
remedies in order to better serve their patients.
Key Words: herbal remedies, dietary supplements, atopic dermatitis
Indexed by the US National Library of Medicine and MEDLINE
Skin Therapy Letter • Editor: Dr. Stuart Maddin • Vol. 7 No. 2 • February 2002
2
before a product reaches the market. Consumers essentially have
no protection against misleading or fraudulent claims made by
herbal manufacturers. Most are not subjected to the strict
rigorous approval processes that traditional drugs are. Most have
not been tested against the gold standard controlled clinical trial,
and thus have no verifiable claim with respect to their safety and
efficacy. Products may be contaminated or may contain varying
amounts of active ingredients. Some have no active ingredients.
7
Up to 30% of herbal patent remedies imported from China have
been laced with potent pharmaceuticals such as steroids and
phenacetin, that should only be available by prescription.
4
Despite the lack of monitoring and quality control, the public tends
to perceive herbal remedies as "natural" and therefore harmless.
This misconception can be dangerous not only because of potential
risks inherent in the therapies, but also because patients may fail to
inform their physician that they are using alternative medicines.
Many herbal remedies may have scientific merit and clinical
benefit. Most may be safe, effective and reliable. However,
adequate testing of herbal remedies and randomized controlled
trials are necessary. The reclassification of herbal medicines as
substances to be regulated by governmental agency is also
essential. Herbal therapy is still scientifically invalid and
inadequately monitored.
4,7
This unconventional practice may be
misleading to patients with chronic skin diseases.
8
General population surveys in the US report that only about 40%
of patients discuss the complimentary medicines they take with
their physicians. There are at least 25 different forms of
complimentary or alternative treatment modality groups.
9
Dermatologists should consider discussing these treatments with
patients, and must be aware of the recent literature available with
respect to alternative therapies.
10-12
Chinese Herbal Treatments
The most commonly used herbal formulations are based on
Chinese medicines, and have been reviewed in the literature.
13,14
Chinese herbs are traditionally used in very complex mixtures
where an unknown number of compounds may be acting
synergistically.
14,15
Although the pursuit of the active component
may be of paramount importance for research and therapeutic
application, the mixture of the herbs work well because of an
interaction of different compounds within the mixture. Whether
or not Chinese herbal therapy (CHT) contains one or more active
compounds, it does represent a potential source of novel
therapeutic compounds.
16
Rustin and Poulter
17
describe the principles of CHT along with
its history using the yin and yang theory, i.e., traditional Chinese
physicians perceive skin disease as a breakdown in the essential
relationship between the yin nourishment and yang activity. Such
a crisis allows the subsequent invasion of the body by pathogenic
factors such as wind, heat and dampness, which further
exacerbate the skin. In these circumstances, CHT seeks to rid the
hostile pathogens and to realign the fundamental yin and yang
balance. Sheehan, et al, published a summary of double blind
clinical trials confirming the efficacy of CHT along with
pharmacological actions of individual herbal components listed
in detail (see Table 1).
18-21
Zemaphyte%
Very few studies are available regarding the use of traditional
CHT products. Sheehan, et al, carried out an 8-week study of 40
adults with long-standing difficult-to-treat AD. This was a
double-blind crossover study with patients randomized to receive
an oral Chinese herbal mixture known as Zemaphyte
®
(Phytopharm PLC) or an inactivated herb placebo. There were
significant improvements noted in itching, erythema, the ability
to sleep, and surface damage in the treatment group. In terms of
potency and quantity required, topical corticosteroid use was
reduced while on active treatment, when compared to those
taking placebo.
18
A similar trial with 47 children showed the
same results over 8 weeks of active treatment. The pharmacology
and mechanisms of action were unknown. There was no evidence
of hematological, renal or hepatic toxicity.
19
A one-year open follow-up study using Zemaphyte
®
with 37
children from the previous study had 10 (27%) patients withdraw
because of inadequate response. Four of the responding patients
withdrew early because the treatment was unpalatable. Also,
preparation required boiling some of the herbal constituents in
600ml water for 90 minutes, which was considered too long by
some patients. Of the remaining 23 patients, seven experienced a
90% reduction in severity and were able to stop the treatment
within 6 months to 1 year. Sixteen patients required continuous
treatment, though their treatments were reduced from one each
day to one every 5 days. In total, 18 out of 23 patients (78%)
demonstrated a 90% reduction in severity at the end of the study.
A reversible asymptomatic elevation of the transaminase level
was seen at 7-14 times normal in two patients. Approximately
33% of the patients had a mild diarrhea in the first few weeks of
treatment.
20
A further long term open trial, included 17 adult patients
21
who
were volunteers from the original trial.
18
At the end of one year,
12 of the 17 adults, or 71% had a greater than 90% reduction in
severity and the other five patients had a 60% reduction in
severity. No patients withdrew. There were no laboratory
abnormalities seen in these adults, and mild diarrhea was the only
major complaint.
21
An open trial comparing the original decoction used by Sheehan,
et al
18
to a new granular preparation showed no difference in
efficacy. However, patients receiving the granular preparation did
comment on the increased palatability and ease of
administration.
22
Commonly, Zemaphyte
®
(Phytopharm PLC) contains a mixture
of 10 herbs with some known pharmacological agents and action.
Analysis of these herbs revealed that none of them had
nonsteroidal anti-inflammatory activities, but some displayed
steroid like or antihistaminic like activities. One ingredient
displayed immunosuppressive activity.
23
Latchman, et al,
discovered that Zemaphyte
®
is associated with a reduction of
serum IgE complexes and that it targets the immunologic features
that seem to be involved in the pathogenesis of AD.
24
A more detailed study of the immune mechanisms in the skin of
patients with AD using Zemaphyte
®
and other non-defined
3
Skin Therapy Letter • Editor: Dr. Stuart Maddin • Vol. 7 No. 2 • February 2002
Chinese herbal therapies revealed that there were no significant
changes in cell numbers (T-Cell subsets, macrophages, or
dendritic cells) in normal skin, but a reduction of CD23 (a low-
affinity IgE receptor) - bearing antigen presenting cells was
reported.
25,26
Down regulation of the low-affinity receptors for
IgE on antigen-presenting cells in patients with AD may
contribute to the benefit observed following treatment with
Zemaphyte
®
.
27
Decreases are also seen in levels of soluble IL-2
receptors and soluble vascular adhesion molecules.
16
mixture of Chinese herbs that she had ingested for about three
years.
33
Soderberg
34
used an open study design with 9 AD patients
taking "herbal medicine" for a 3 week period and found that 5
patients’ condition had worsened. Similar drop-outs were reported
in an open trial where six of eight patients withdrew because of
exacerbation of their disease.
35
Other side-effects have been
reported with the use of CHT, but not specifically in AD patients.
17
Keane et al.
36
studied 11 Chinese herbal creams obtained from
patients attending general and pediatric dermatology outpatient
Alternative Rx - Herb Double- Outcome Side-effects
Investigators blinded
Chinese Herbal Therapy - Zemaphyte
®
yes Mixed Diarrhea, increase in transaminases,
Sheehan et al
18
, Fung
28
and generic Reversible dilated cardiomyopathy, reversible
mixtures acute hepatic illness related, fatal hepatic necrosis,
nephropathy, exacerbation of disease
Chamomile mild extract – Kamillosan
®
yes Mild superiority vs. Possible allergic contact dermatitis from
Patzelt-Wenczler
39
0.5% hydrocortisone; non-trade brand
marginal difference
vs. placebo
Evening primrose oil – Efamol
®
or yes Mixed Rare
Lovell,
43
Schalin-Karila,
44
Epogam
®
Wright,
45
Gehring,
46
Bamford,
50
Hederos
51
Shiunko – Higaki
52
? yes Mixed ?
Witch Hazel – Norman
38
N/A no Anecdotal ?
Burdock - Norman
38
N/A no Anecdotal ??
Aloe vera - Norman
38
N/A no Anecdotal Allergic contact dermatitis
Oolong Tea – Uehara
55
N/A no Anecdotal ?
There have also been negative effects reported for this remedy. In
a study using Zemaphyte
®
with 40 patients, 37 completed the
trial. There seemed to be a general trend of clinical improvement,
however there was no statistically significant treatment effect of
the herbal therapy or placebo in the four clinical parameters
studied (erythema, surface damage, lichenification, and scaling).
Hematological, renal and liver function tests were all normal
throughout the trial. The investigators concluded that further
research was required to evaluate the efficacy of this herbal
medication.
28
Other Chinese Herbal Therapies
Reversible dilated cardiomyopathy was reported in one patient who
received 2 weeks of therapy from a Chinese herbalist in Soho,
London. The CHT mixture contained more than 30 herbal
components.
29
Two patients suffered a reversible acute hepatic
illness after taking traditional Chinese herbs,
30
and another patient
was reported to have suffered fatal hepatic necrosis.
31
Another case
of hepatoxicity was reported, though the exact herbs were not
stated.
32
A19-year-old female with AD presented with symptomatic
nephropathy from aristolochic acid that contained an undefined
clinics. High-resolution gas chromatography and mass
spectrometry were used to determine their content. Eight of the
11 creams contained dexamethasone. All of these creams had
been used in sensitive skin areas including facies and folds.
They concluded that greater regulations need to be imposed on
Chinese herbalists to prevent the illegal and inappropriate
prescribing of potent steroids.
Herbs
Dried and fresh flowers of the chamomile plant have been used
medicinally around the world for many years. In vitro chamomile
extracts inhibit both lipoxygenase and cyclooxygenase, and can
also inhibit histamine release.
38
Kamillosan
®
cream contains a
mild chamomile extract as the active ingredient, which
demonstrated no chamomile related allergen potential, and has
been used for local therapy of AD. In a partially double blind and
randomized study carried out as a half side comparison, the
cream was compared with hydrocortisone 0.5% cream, and with
the vehicle cream as the placebo in patients suffering from
medium degree AD. After a 2-week treatment, a mild superiority
was demonstrated when compared to hydrocortisone 0.5% and a
Table 1:
Alternative Treatments for Atopic Dermatitis
Skin Therapy Letter • Editor: Dr. Stuart Maddin • Vol. 7 No. 2 • February 2002
4
marginal difference was found when compared to the placebo.
39
However, allergic contact dermatitis from chamomile used in
phytotherapy (i.e., the use of vegetable drugs in medicine) has
been reported.
40
Evening primrose oil (Efamol
®
, NUMICO) has been reported to
benefit children with AD.
41,42
This medication is usually taken
orally. Several randomized, double-blind studies found evening
primrose oil to be more effective in treating the signs and
symptoms of AD.
43-45
In a vehicle-controlled study of its effect
on barrier function in AD, topical evening primrose oil in an
amphiphilic and in a stable water-in-oil emulsion was compared
in 20 AD patients. Evening primrose oil proved to have a
stabilizing effect on the stratum corneum barrier, but this was
apparent only in the water-in-oil emulsion and not in the
amphiphilic emulsion. Therefore, the vehicle is extremely
important.
46
A defect in the function of the enzyme delta-6-desaturase has
been postulated as a factor in the development of AD. The
rationale for using evening primrose oil rests in this functional
defect. Delta-6-desaturase converts linoleic acid to gamma
linoleic acid, and evening primrose oil is rich in gamma linoleic
acid.
47
Supplementation with oral evening primrose oil for AD
patients has demonstrated moderate and favorable fatty acid
changes in their epidermis.
48
Topically applied gamma-linoleic
acid has also been shown to be effective for treating AD because
of its anti-pruritic and anti-inflammatory effects.
49
However,
gamma-linoleic acid (GLA) contains pyrolizidine alkaloids,
which can cause hepatotoxicity with chronic consumption.
4
No
toxicity data for topical preparations of evening primrose oil is
available. Data on its effectiveness in treating AD is mixed,
however. In a double blind, blocked crossover design with
random assignment of 123 patients
50
and another double blind,
placebo-controlled study of 60 AD children in Sweden using
Epogam
®
(Scotia) produced similar negative results.
51
AD was
unresponsive to evening primrose oil. Treatment of AD with
GLA remains controversial.
11
Shiunko
Shiunko is a topical medication made from herbal extracts and is
used to treat a range of conditions including AD. In a vehicle-
controlled study of nine patients, Shiunko was effective in four
patients when compared to petrolatum, but in only one patient when
compared with 3.5% saltwater. This herb has antibacterial effects on
Staphylococci and this is the proposed mechanism of action.
52
This may be similar to the beneficial effects seen with topical
fusidic acid (Fucidin Intertulle
®
, Leo Pharma), which is not an
herbal preparation, but a topical antibacterial agent.
53,54
Other
alternative remedies listed to help eczema, but not necessarily
AD include Witch Hazel, burdock and aloe vera
38
and Oolong
tea.
55
Proper studies are very scant.
Herbal Allergens
Cosmetics, shampoos, herbal creams, and ingested herbal
remedies and tonics may also contain Compositae plant
extractions. The Compositae family includes plants such as the
artichoke, burdock, chamomile, chrysanthemum, marigold,
ragweed, and sunflower. The most common allergen in this
family is the sesquiterpene lactones, present in the oleoresin
fraction of the leaf, stem, flower and possibly pollen. Compositae
dermatitis is most frequently seen in middle-aged and elderly
people presenting with an air-borne or direct contact dermatitis.
37
Conclusion
Plant substances have been used as medicines for thousands of
years. Recent research indicates that some herbs offer
considerable medicinal benefits. Currently, the level of interest in
alternative treatments by the general public continues to increase.
Some patients who obtain care from dermatologists use OTC
herbal remedies.
38
Dermatologists need information about the effects of herbal
remedies in order to better serve their patients.
38
It is also
important for dermatologists to give their patients the opportunity
to be heard and understood. The greatest resource is time, and it
should be offered and used effectively.
2
Acknowledgments
Thanks to R. Gottshalk, S. Maddin, F. Murphy, G.E. Piérard, P.
Roth, K. Scully, F. Tabassum, and J. Wismer for their suggestions
in preparing his manuscript.
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51. Hederos CA, Berg A. Epogam evening primrose oil treatment in atopic
dermatitis and asthma. Arch Dis Child 75(6):494-7 (1996 Dec).
52. Higaki S, Morimatsu S, Morohashi M, Yamagishi T, Hasegawa Y.
Susceptibility of Propionibacterium acnes, Staphylococcus aureus and
Staphylococcus epidermidis to 10 Kampo formulations. J Int Med Res
25(6):318-24 (1997 Nov-Dec).
53. Symposium Report: Eighth congress of the European Academy of
Dermatology and Venereology. Amsterdam Sept 1999; Leo Pharmaceutical
Products.
54. Ramsay CA, Savoie JM, Gilbert M, et al: The treatment of atopic dermatitis
with topical fucidic acid and hydrocortisone acetate. J Eur Acad Dermatol
Venerol 7(suppl 1):S15-22 (1997).
55. Uehara M, Sugiura H, Sakurai K. A trial of oolong tea in the management of
recalcitrant atopic dermatitis. Arch Dermol 137(1):42-3 (2001 Jan).
W
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’
RE ON THE
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www.skincareguide.com
Skin Therapy Letter • Editor: Dr. Stuart Maddin • Vol. 7 No. 2 • February 2002
6
Drug Class Generic/Trade/ Indiction Approving
Company Names Regulatory Agency
Anti-acne Azelaic Acid For the topical treatment of mild-to-moderate US FDA
Agents Finevin
®
Cream 20% inflammatory acne.
Berlex Laboratories
Clindamycin 1%, Benzoyl Peroxide 5% Labeling change: the product can now be stored US FDA
BenzaClin™ at room temperature for up to 2 months after
Dermik Laboratories being dispensed by a pharmacy.
Ethinylestradiol, Norethindrone Acetate Additional indication: for the treatment of US FDA
Estrostep
®
moderate acne in women over 15 years of age.
Pfizer
Tazarotene For the treatment of acne vulgaris. US FDA
Tazorac
®
0.1%
Allergan
Tretinoin Gel For the treatment of acne vulgaris. TPP – Canada
Retin-A Micro Microsphere
®
AP Pharma/Johnson & Johnson Canada
Antibacterial Cefuroxime, Dextrose for Injection For the treatment of skin and skin structure infections, US FDA
Agents Zinacef
®
lower respiratory tract infections,urinary tract infections,
GlaxoSmithKline septicemia, meningitis, gonorrhea, bone and joint infections.
Ciprofloxacin ANDA tentatively approved for this generic form of US FDA
Geneva Pharmaceuticals Bayer’s Cipro
®
for the treatment of urinary tract, skin
and other infections.
Moxifloxacin HCl Additional indication: as a once daily treatment for US FDA
Avelox
®
uncomplicated skin and skin structure infections due to
Bayer Staphylococcus aureus and Streptococcus pyogenes.
Antifungal Caspofungin Acetate For the treatment of invasive aspergillosis in US FDA
Agents Cancidas
®
patients who do not respond to, or cannot
Merck tolerate other antifungal therapies.
Butenafine HCl Switched to OTC for the topical treatment of US FDA
Lotrimin Ultra
®
1% Cream symptomatic inflammatorytinea pedis, tinea cruris and
Schering-Plough tinea corporis due to Epidermophyton rubrum.
Butenafine HCl Additional indication: for the treatment of tinea US FDA
Mentax
®
1% Cream (pityriasis) versicolor caused by Malassezia furfur,
Bertex Pharmaceuticals previously known as Pityrosporum orbiculare.
Clotrimazole, Betamethasone For the treatment of a variety of fungal conditions. It is US FDA
Dipropionate Cream bioequivalent to Schering-Plough’s Lotrisone
®
cream.
Taro Pharmaceuticals
Antihistamine Desloratidine To be given once daily for the symptoms of European Commission
Aerius™ & Neoclarityn™ 5mg. tablets chronic idiopathic urticaria in adults and of the European Union
Schering-Plough children >12 years of age.
Levocetirizine For the treatment of seasonal allergic rhinitis, German
Xyzal
®
/Xusal
®
perennial allergic rhinitis, and chronic Regulatory
Sepracor idiopathic urticaria Authorities
Antimetabolite Methotrexate For the treatment of neoplastic disease, psoriasis and US FDA
Agents Trexall
®
rheumatoid arthritis. Trexall
®
represents new dosage
Barr Laboratories/DuPont Pharmaceuticals strengths in 5, 7.5, 10, and 15mg tablets.
Antipsoriatic Calcipotriol, Betamethasone Dipropionate For the treatment of psoriasis TPP – Canada
Agents Dovobet
®
Ointment
Leo Pharma
Antiviral Varicella Zoster Immune Globulin This product is a highly purified and specialized antibody TPP – Canada
Agents VariZIG
®
against the varicella zoster virus that causes chicken pox.
Cangene
Valacyclovir HCl A shorter course of therapy: the new 500mg. caplets can US FDA
Valtrex
®
500mg. caplets be prescribed as a 3-day course administered twice daily.
GlaxoSmithKline
Atopic Pimecrolimus For the treatment of mild-to-moderate atopic dermatitis US FDA
Dermatitis Elidel
®
Cream 1% in patients >2 years of age.
Novartis Pharmaceuticals
Drug Treatments for Skin Disease Introduced in 2001
Skin Therapy Letter • Editor: Dr. Stuart Maddin • Vol. 7 No. 2 • February 2002
7
Drug Class Generic/Trade/ Indiction Approving
Company Names Regulatory Agency
Depigmenting Xtrac™ Excimer Laser System For the treatment of psoriasis and vitiligo. US FDA
Agents PhotoMedex
Enzyme Recombinant Human Iduronidase Granted Orphan Drug Status for the proprietary treatment US FDA
Replacement (IDUA) of mucopolysaccharidosis I.
Therapy Novazyme Pharmaceuticals
Agalsidase Alfa For long-term treatment in patients with Norwegian Medicines
Replagal™ Fabry’s disease. Agency
Transkaryotic Therapies (TKT) NZ’s Reg. Authority
Iceland’s Regulatory
Authority
Agalsidase Beta For the long-term enzyme replacement therapy in European
Fabrazyme™ patients with a confirmed diagnosis of Fabry’s disease. Commission of the
Genzyme European Union
Hair Growth Eflornithine HCl For the reduction of unwanted facial hair in women. US FDA
Vaniqa
®
Cream 13.9% TPP - Canada
Westwood-Squibb
HIV/AIDS Amprenavir Conditional Notice of Compliance: to be used with TPP – Canada
Agenerase
®
other antiretroviral agents for the treatment of HIV-1
Glaxo Wellcome infection.
HIV Drug Resistance Test This test can identify which HIV medications have US FDA
Trugene® HIV-1 Genotyping Test become ineffective because of the virus’ mutation in
Visible Genetics individual patients.
Tenofovir Disoproxil Fumerate For the treatment of HIV infection when taken in US FDA
Viread
®
combination with other antiretroviral agents
Gilead Sciences
Valganciclovir For the treatment of cytomegalovirus (CMV) retinitis US FDA
Valcyte
®
in AIDS patients
Hoffmann-LaRoche
Hormonal Transdermal 17-Beta Estradiol For the treatment of menopausal symptoms and for the Netherlands’
Preparation Estradot
®
prevention of postmenopausal osteoporosis. Regulatory
Novartis Pharmaceuticals Canada Authority
Human Skin Biologically Active Dressing For patients undergoing hand reconstruction to treat US FDA
Construct Composite Cultured Skin (CCS)
®
recessive dystrophic epidermolysis bullosa, a rare
Ortec International genetic disorder.
Monoclonal Infliximab For the treatment of severe, active and fistulizing TPP – Canada
Antibody Remicade
®
Crohn’s Disease in adult patients who have not
Centocor responded to conventional treatment
Mouth and Amlexanox For the treatment of aphthous ulcers. UK MCA
Throat Aptheal
®
5% Paste
Product Strakan Ltd.
Neurotoxins Botulinum Toxin Type A Additional indication: for the treatment of glabellar TPP – Canada
BOTOX
®
lines associated with corrugator and/or procerus
Allergan muscle activity.
Oncologic Arsenic Trioxide Orphan drug designation given for the treatment of European Commission
Agents Trisenox
®
multiple myeloma and myelodysplastic syndromes. of the European Union
Cell Therapeutics
Oral Drospirenone/Ethinyl Estradiol Contains the progestin drospirenone, which exhibits US FDA
Contraceptive Yasmin
®
antimineralocorticoid activity and influences water and
Berlex Laboratories electrolyte balance. Reduces sebum output.
Photodynamic Aminolevulinic Acid HCl For the treatment of Actinic Keratosis of the face TPP – Canada
Therapy Levulan® Kerastick™ Photodynamic and scalp.
Therapy
Draxis Health/DUSA Pharmaceuticals
Sunscreens Mequinol 2%, Tretinoin 0.01% For the treatment of solar lentigines and related TPP – Canada
Solagé® Topical Solution hyperpigmented lesions.
Westwood Squibb
Skin Therapy Letter • Editor: Dr. Stuart Maddin • Vol. 7 No. 2 • February 2002
8
Skin Therapy Letter:(ISSN 1201–5989) Copyright 2002 by SkinCareGuide.com. The Skin Therapy Letter
©
is published 10 times annually by SkinCareGuide.com Ltd, 450 – 688 West Hastings, Vancouver, British Columbia,
Canada, V6B 1P1. Publications Editor: Penelope Gray-Allan: 604- 633-1926, email: grayallan@skincareguide.com. All rights reserved. Reproduction in whole or in part by any process is strictly forbidden without prior consent
of the publisher in writing. While every effort is made to see that no inaccurate or misleading data, opinion or statement appears in the Skin Therapy Letter
©
, the Publishers and Editorial Board wish to make it clear that the data
and opinions appearing in the articles herein are the responsibility of the contributor. Accordingly, the Publishers, the Editorial Committee and their respective employees, officers and agents accept no liability whatsoever for
the consequences of any such inaccurate or misleading data, opinion or statement. While every effort is made to ensure that drug doses and other quantities are presented accurately, readers are advised that new methods and
techniques involving drug usage, and described herein should only be followed in conjunction with the drug manufacturer’s own published literature. Printed on acid free paper effective with Volume 1, Issue 1, 1995.
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Update on Drugs
Class Name/Company Approval Dates and Comments
Drug News
Photodynamic
Therapy
Photodynamic Therapy
Metvix
®
PDT
Photocure ASA
New Zealand’s regulatory authority gave marketing authorization in
February 2002, for the treatment of actinic keratosis and basal-call
carcinoma in patients for whom traditional therapies are unsuitable.
This treatment is already approved in 14 European countries and
applications are pending in Australia, the US and Switzerland.
Etanercept
Enbrel
®
Immunex
The US FDA approved this product in January 2002, for the
treatment of psoriatic arthritis.
Drug
Interactions
According to an article published in the British Journal of Clinical Pharmacology* St. John’s Wort, which is a
popular herbal treatment for depression, increases P-glycoprotein expression. As a result, patients taking drugs
that act as P-glycoprotein substrates, such as indinavir and cyclosporin, should not take this herbal remedy.
*British Journal of Clinical Pharmacology 53:75-82 (2002)
New Topical
Delivery System
CollaGenex Pharmaceuticals has licensed a novel dermal and transdermal drug delivery system named
Restoraderm
®
. This technology is designed to enhance the dermal delivery of a variety of active
ingredients, and is based on the ability of certain lipid compositions to enhance the natural skin barrier to
facilitate dermal and transdermal delivery. This technology is currently still under development.
HIV/AIDS
Antibacterial
Agent
Moxifloxacin HCl IV
Avelox
®
Bayer
The US FDA approved an IV formulation of this antibacterial agent in
December 2001, for the treatment of community-acquired pneumonia,
uncomplicated skin and skin structure infections, acute bacterial
sinusitis, and acute bacterial exacerbations of chronic bronchitis in
adults. Avelox is also available in tablet form. The IV and tablet forms
are bioequivalent, so no dosing adjustment is required.
Antihistamine
Desloratidine Syrup &
Disintegrating Tablets
Schering-Plough
Antipsoriatic
Agent
The Committee for Proprietary Medicinal Products of the European
Agency for the Evaluation of Medicinal Products (EMEA) issued a
positive opinion recommending approval of these formulations in
January 2002 for the treatment of seasonal allergic rhinitis and
chronic idiopathic urticaria. The syrup is recommended for patients
>2 years of age, and the disintegrating tablets are labeled for
patients >12 years of age.
Depigmenting
Agent
Hydroquinone, Tretinoin &
Flucinolone Cream
Tri-Luma
®
Hill Dermaceuticals
The US FDA approved this cream in January 2002, for the short-
term treatment of moderate to severe melasma of the face in the
presence of sun-avoidance measures, including sunscreen use.
Bristol-Myers Squibb Canada announced that Videx ED
®
(didanosine) is now available for sale in Canada
as of January 2, 2002. This nucleoside analogue is used to treat adults who are infected with HIV, with a
dosage of 1 capsule daily.