Various types of dressings have been used successfully in the treatment of atopic dermatitis. In this study we looked at the efficacy of two of the newer topical steroids when applied under wet wrap dressings for the treatment of refractory atopic dermatitis in children. Forty children with moderate to severe disease were randomized to receive either one-tenth-strength diluted 0.1% mometasone furoate ointment or one-tenth-strength diluted 0.005% fluticasone proprionate ointment. These were applied once a day over a 4-week period without wet wraps, or for 2 weeks without wet wraps followed by 2 weeks of application under wet wraps. There was a 2-week period for all patients when the topical treatment was standardized. At weekly follow-ups, patients were assessed by a single, blinded observer and objectively scored for disease extent and severity. A subjective score was also given for the impact of eczema on daily living. There was significant improvement in the disease severity from baseline during the first 2 weeks of the open application arm (p=0.043), however, additional beneficial effects were limited after week 2. Wet wraps further improved the disease severity and extent after week 2 (p < 0.05), and were well tolerated. We concluded that both 0.1% mometasone furoate and 0.005% fluticasone proprionate ointments are effective in the treatment of atopic dermatitis, and that wet wraps are useful in further improving refractory disease in children.
Fluocinolone acetonide 0.01% in a blend of refined peanut and mineral oils has been established as effective and safe treatment for atopic dermatitis in patients 2 years and older, including those with peanut sensitivity, for several years. We sought to study the safety of fluocinolone acetonide 0.01% oil and its potential for adrenal axis suppression in infants as young as 3 months of age. A controlled, open-label study was performed in children aged 3 months to 2 years with moderate to severe atopic dermatitis at two academic pediatric dermatology centers. Patients received topical fluocinolone acetonide 0.01% oil twice daily to affected areas involving a minimum of 20% body surface ratio for 4 weeks. Cortisol stimulation testing was performed at baseline and at the end of the treatment phase. Patients were monitored for medication use and adverse events. Efficacy was assessed using the Investigator Global Severity and Response scales. Thirty-two patients with moderate to severe atopic dermatitis were recruited into the study and 30 were evaluated with the Physician's Global Improvement Assessment tool. The mean body surface ratio treated for all age groups was 48%. Eighty-three percent of patients had marked or better improvement scores by week 2 and 96% by week 4, with 40% completely cleared. No adrenal suppression occurred in the 24 patients that met inclusion criteria for hypothalamus-pituitary axis (HPA) axis analysis. No relevant adverse events occurred. Results of this study support the safety and efficacy of fluocinolone acetonide 0.01% in refined peanut oil vehicle, for infants as young as 3 months of age with atopic dermatitis. No evidence of adrenal suppression or adverse local effects was demonstrated after 4 weeks of twice daily treatment.
Although acne vulgaris is common in preadolescents (<13 yrs), few acne treatments are currently approved for children. This study assessed the safety and efficacy of tretinoin microsphere gel (TMG) 0.04% pump in children aged 9-11 with acne vulgaris. In this multicenter, randomized, double-blind, vehicle-controlled pilot study, patients applied TMG 0.04% pump or vehicle once daily to the face for 12 weeks. Efficacy measures were changes in facial lesion counts, Investigator Global Evaluation of acne severity using two scales, and Investigator Global Assessment of Improvement from baseline to week 12. Of the 110 patients enrolled, 55 received TMG 0.04% pump, and 55 received vehicle. At week 12, there was significantly greater improvement in the least-squares mean change in noninflammatory lesions with TMG 0.04% than with vehicle (-19.9 vs -9.7, p = 0.04) and a significant difference in Investigator Global Assessment of improvement at week 12 between the children treated with TMG 0.04% pump and those treated with vehicle (p = 0.02), but there were no discernible differences in static acne severity scales. Change from baseline in signs and symptoms of cutaneous irritation were similar between the active and vehicle arms at week 12. This study demonstrated statistically significant differences in the reduction of noninflammatory lesions between TMG 0.04% pump and vehicle in patients aged 9-11 with acne vulgaris. Additional studies are warranted to further characterize the safety and efficacy of TMG 0.04% pump for the treatment of acne in the preadolescent population.
A retrospective analysis of 25 infants and young children with anogenital warts was performed by chart review and telephone interview. Fifteen of 17 patients treated with podofilox 0.5% gel and 6 of 8 patients treated with imiquimod 5% cream improved or cleared with therapy. Only one patient stopped treatment because of irritation. Our experience suggests that these agents can be used safely and effectively in young children. Controlled prospective studies should be undertaken to further evaluate the use of podofilox and imiquimod in the treatment of symptomatic anogenital warts in children.
Nail psoriasis occurs in 7% to 40% of children, with a similar pattern of clinical presentation to that of adults. In 0.6% to 2.3% of the patients nail changes appear as the only sign of the disease, preceding other skin and articular involvement. No pediatric clinical trials are available yet, but considering the successful use of tazarotene for nail dystrophy therapy in adults, we chose this drug to treat a child.
Desonide, a low potency corticosteroid, has been used widely as a topical treatment for inflammatory dermatoses for over 30 years. A recent formulation advance has enabled the development of desonide 0.05% into a novel moisturizing aqueous gel (hydrogel) that is free of alcohol and surfactants. This multicenter, open-label study evaluated the hypothalamic-pituitary-adrenal axis suppression potential, tolerability, and efficacy of this new Class VI topical steroid formulation in pediatric subjects with moderate-to-severe atopic dermatitis (mean body surface area = 51%). Forty children, aged 6 months to 6 years were enrolled and treated twice daily for 4 weeks. Desonide hydrogel 0.05% was well tolerated and no treatment-related adverse events were reported. No suppression of adrenal function was observed in subjects who completed the study without protocol violations related to cosyntropin administration or cortisol testing (n=34). Of the subjects who completed the study with complications in cortisol testing (n=3), there was one subject (1/37=3%) who had a low poststimulation cortisol level at week 4. Efficacy was demonstrated by marked improvement in overall disease state and in the signs and symptoms of atopic dermatitis. This study validates the systemic safety of a novel desonide hydrogel formulation in young pediatric patients and confirms the longstanding tolerability and efficacy profile of desonide.
Corticosteroids are currently the first line of treatment for patients with atopic dermatitis. In the pediatric population however, the potential impact of adrenal suppression is always an important safety concern. Twenty boys and girls, 5-12 years of age, with normal adrenal function and a history of atopic dermatitis were maximally treated three times daily with a lipid-rich, moisturizing formulation of hydrocortisone butyrate 0.1% for up to 4 weeks. At the conclusion of the 4-week treatment period, cosyntropin injection stimulation testing showed no evidence of adrenal suppression. In addition, the therapy was noted to be highly efficacious, with a clinical success rate of 80% (Physician Global Score of (0) clear or (1) almost clear). No local side effects associated with prolonged use of topical corticosteroids were reported. In summary, this study supports the contention that this lipid-rich, moisturizing formulation of hydrocortisone butyrate 0.1% was a well-tolerated and beneficial treatment for atopic dermatitis, demonstrating no adrenal suppression in the pediatric population aged 5-12 years. The relevance of these findings for children below 5 years of age, because of difference in body mass/surface area ratios, remains to be determined.
Therapeutic options for superficial infantile hemangiomas (IH) are limited. Recently, timolol maleate gel, a topical nonselective beta-blocker, has been reported as a potentially effective treatment for superficial IH. This study is an extension of a previously published pilot study designed to further investigate the efficacy and safety and to identify predictors of good response of topical 0.5% or 0.1% timolol maleate gel-forming solution. This was a retrospective cohort study including patients enrolled from five centers. Patients were included if they were treated with timolol maleate 0.1% or 0.5% gel-forming solution and had photographic documentation of the IH and at least one follow-up visit. Patients with concomitant active treatment using other IH treatments were excluded. The primary endpoint was change in the appearance of IH as evaluated using a visual analog scale (VAS). Data from 73 subjects were available for final analysis. Timolol maleate gel-forming solution 0.5% was used in 85% (62/73) of patients, the remainder being treated with 0.1%. The median age at treatment initiation was 4.27 months (interquartile range [IQR] 2.63-7.21 mos), and patients were treated for a mean of 3.4 ± 2.7 months. All patients except one improved, with a mean improvement of 45 ± 29.5%. Predictors of better response were superficial type of hemangioma (p = 0.01), 0.5% timolol concentration (p = 0.01), and duration of use longer than 3 months (p = 0.04). Sleeping disturbance was noted in one patient. This study further demonstrates the efficacy and tolerability of topical timolol maleate and gradual improvement with longer treatment in patients with superficial IH.
Keratosis pilaris is common, but little information exists regarding effective therapy for this sometimes clinically and often cosmetically troublesome disorder. This small pilot study compared the efficacy of Aquaphor ointment with tacrolimus ointment 0.1% and found that both were effective and well tolerated by patients.
Infantile acne is an uncommon condition in pediatric age. We determined the efficacy and safety of adapalene gel 0.1% in the treatment of infantile acne. Twelve patients were enrolled for adapalene gel 0.1% application once daily over a 16-week treatment period. Efficacy evaluation included counting the inflammatory and noninflammatory lesions by the physician and global evaluation of the improvement. After 16 weeks all patients were followed up for a 1-year period. The time of clearance of the infantile acne lesions was 3 months in four (33%) patients and 4 months in eight (67%) patients (median 3.4 months). Adapalene gel produced reductions in noninflammatory and inflammatory lesions counts. Limited side effects were observed and none of them required stopping the therapy. No patient was left with scarring. Three patients were showed mild lesions in the 1-year follow-up period. Adapalene gel 0.1% was found to be a highly effective and safe drug in the treatment of mild-to-moderate infantile acne.
A petrolatum and zinc oxide-based ointment containing 0.25% miconazole nitrate is reported to be effective and well tolerated in the treatment of diaper dermatitis complicated by cutaneous candidiasis (DDCC). This prospective, multicenter, open-label, long-term, phase IV study investigated the potential resistance of Candida spp. to repeated topical use of 0.25% miconazole nitrate in infants age 15 months and younger with moderate to severe DDCC. For initial and recurring episodes of DDCC over the 2-year study period, subjects were treated with a 7-day course of 0.25% miconazole nitrate ointment (active components: miconazole nitrate 0.25%, zinc oxide 15%, and white petrolatum 81.35%) with a 7-day follow-up. Clinical and mycologic evaluations were conducted before treatment (day 0) and 7 days after treatment (day 14). Potential resistance to miconazole was defined using an arbitrary breakpoint of minimum inhibitory concentration of 2 μg/mL. There was no evidence of resistance to miconazole in Candida spp. after single or repeated treatment courses of 0.25% miconazole nitrate ointment. For the initial episode of DDCC, 83 of 168 subjects (49.4%) achieved a clinical cure, 77 (45.8%) achieved a mycologic cure, and 49 (29.2%) achieved an overall cure (clinical and mycologic). The overall cure rate for recurrent episodes of DDCC was similar to or numerically greater than rates observed for the initial episode. Treatment of DDCC with 0.25% miconazole nitrate ointment was effective and generally well tolerated. No evidence of the development of resistance to miconazole in Candida spp. was observed.
Treatments for mild to moderately severe acne usually combine retinoid and antimicrobial therapy. Recently, the US FDA approved the combination of 1.2% clindamycin (CLIN) and 0.025% tretinoin (RA) in a novel gel formulation for the treatment of mild to moderate acne, based on results from two 12‐week, multicenter, double‐blind Phase 3 trials in which patients were randomized to four treatment arms: CLIN/RA, CLIN, RA, and vehicle. The trials studied more than 4500 patients 12 years of age or older. In both trials, CLIN/RA gel produced significantly greater clinical improvements than vehicle or either monotherapy. CLIN/RA was safe and well tolerated in both trials and in a 52‐week safety follow‐up evaluation. The current study is a subgroup analysis that evaluates CLIN/RA’s effects on acne lesion prevalence in 12‐ to 18‐year‐old patients with mild to severe baseline acne severity. CLIN/RA significantly reduced the number of inflammatory, noninflammatory, and total acne lesions after 12 weeks of treatment (p ≤ 0.004) in 1,710 patients aged 12 to 18 years. Relatively greater improvements were seen following CLIN/RA treatment compared to CLIN or RA monotherapy, or the vehicle gel beginning as early as 2 weeks following treatment initiation. This novel CLIN/RA gel for treating acne is tolerable and safe and offers clinicians and teen aged patients a new and efficacious intervention for acne vulgaris.
[Abstract amended after online publication date June 8, 2009]
Diaper dermatitis, an acute inflammation of the skin in the diaper area, is the most common dermatologic disorder of infancy. This placebo-controlled, randomized, double-blind, parallel-group trial compared the efficacy and safety of miconazole nitrate 0.25% in a zinc oxide/petrolatum base with that of the ointment base alone in treating acute diaper dermatitis in infants and evaluated the role of Candida albicans in the response to treatment. Infants age 2-13 months with diaper rash were treated with either miconazole nitrate 0.25% (N = 101) or ointment base (N = 101) for 7 days. Although improvement in rash from baseline was seen in both treatment groups on days 3, 5, and 7, patients receiving miconazole nitrate 0.25% had significantly fewer rash sites and lower mean total rash scores on days 5 and 7 (p < 0.001). In the miconazole nitrate 0.25% group, improvement was most marked among those with moderate or severe diaper dermatitis at baseline and among patients whose baseline rashes were positive for C. albicans. Treatment with miconazole nitrate 0.25% was as safe as with ointment base alone. Miconazole nitrate 0.25% ointment is a safe and effective treatment for diaper dermatitis in infants.
One hundred seventy-two subjects with head lice participated in a five-way, investigator-blinded, parallel-group, active-controlled study comparing 0.5% malathion gel (30, 60, and 90 minutes applications), Ovide Lotion (0.5% malathion), and Nix Crème Rinse (1% permethrin). All subjects were treated on day 1. Participants were reevaluated at day 8 +/- 1 and those with live lice were retreated with the same product, for the same duration as day 1. Cure, defined as the absence of live lice, was evaluated 14 +/- 2 days after the last treatment and 161 subjects completed the study according to the protocol. Compared to Nix, treatment success rates were statistically superior for all malathion gel and Ovide groups. Retreatment rate for Nix was 70%, which was statistically more than the malathion groups. The highest treatment success rates were observed for the 30-minute malathion gel (98% intent-to-treat and 100% per-protocol [PP]) and the 8 to 12 hour Ovide application (97% intent-to-treat and 100% PP). In conclusion, the 30-minute malathion gel, which contains the same ingredients and concentrations as Ovide, provides comparable efficacy, offers increased safety and is more cosmetically acceptable than Ovide.
We report three cases of successful treatment of proliferating deep infantile hemangiomas with topical timolol 0.5% gel-forming solution (GFS) used two to three times daily. We recommend considering timolol as an initial option for small, deep facial hemangiomas that are not causing functional compromise or complications but may have an unsatisfactory cosmetic appearance. In our experience, albeit limited, this is a safe alternative to watchful waiting.
The safety of a novel 0.5% ivermectin lotion (IVL) and potential for ivermectin absorption after application was investigated in an open-label study in young children, and a human repeat insult patch test (HRIPT) and cumulative irritation test (CIT) assessed any potential for cumulative dermal irritation and contact sensitization. In the pharmacokinetic and safety study, 30 head louse-infested children ages 6 months to 3 years received a 10-minute application of IVL on day 1. Blood was collected before application; 0.5, 1, and 6 hours after rinsing; and on days 2 and 8. Samples from 20 subjects were assayed for ivermectin (test sensitivity 0.05 ng/mL). Liver panel and complete blood counts were completed for all subjects. For the HRIPT/CIT, occlusive patches containing IVL or vehicle control lotion (CL) were repeatedly applied to 220 healthy adult subjects to assess contact sensitization; for cumulative dermal irritation testing, additional patches with normal saline and sodium dodecyl sulfate (SDS) were applied to 36 subjects. In the open-label study, all detected ivermectin plasma concentrations were <1 ng/mL. No safety signals emerged, and treatment was well tolerated. In the HRIPT/CIT, IVL was significantly less irritating than normal saline and SDS, with no evidence of dermal irritation or sensitization in human skin. IVL was safe when applied topically, absorption was de minimus, there was no evidence of irritation or sensitization from repeated exposures, and results support the safety of topical IVL use in children as young as 6 months.
Our objective was to conduct a randomized, investigator-blinded evaluation of the pediculicidal and ovicidal activity of a reduced application time (20 minutes) of Ovide (0.5% malathion) compared to Nix (1% permethrin) in a south Florida population infested with Pediculus humanus capitis. Either Ovide or Nix was applied according to the label instructions. However, Ovide application time was reduced to 20 minutes. At day 8, subjects with live lice were re-treated with the same product and procedure as on day 1. Ovicidal and pediculicidal efficacy were evaluated at days 8 and 15. A subject free of lice and viable eggs at day 15 was considered to be a treatment success. Percent efficacy was calculated using the number of subjects free of lice and viable eggs per total number of subjects treated. We found that a 20-minute application of Ovide was significantly more pediculicidal and ovicidal (98%) compared to Nix (55%) at day 15 (p < 0.0001). The percentage of Ovide subjects who required treatment at day 8 was half that of the Nix group. The reinfestation rate was 0% with Ovide and 33% with Nix. In conclusion, a 20-minute treatment with Ovide, instead of the approved 8- to 12-hour application, cured 40 of 41 subjects (98%), demonstrating superior efficacy to Nix. The poor efficacy of Nix confirms the resistance of head lice to permethrin in south Florida.
Linear scleroderma is a connective tissue disorder that characteristically involves the skin. Skin induration and pigmentary changes present in a linear distribution. Severe functional and cosmetic disability may occur, especially in growing children. No effective therapy for the fibrotic stage of scleroderma is available at present. Recently a beneficial effect of oral 1, 25-dihydroxyvitamin D3 (calcitriol) treatment was reported in adults. Calcitriol has a dose-dependent inhibition on fibroblast proliferation and collagen synthesis and has immunoregulatory activities. We assessed the efficacy of oral calcitriol treatment in seven pediatric patients with linear scleroderma. During the treatment dietary calcium intake was restricted. Calcium, inorganic phosphate, creatinine, and urea in the serum and urine was monitored. The urinary calcium:creatinine ratio was measured. The effects of the treatment were evaluated using a clinical scoring system. No side effects were observed. Five of the seven patients showed a good to excellent improvement of their lesions. One of them partly relapsed after 19 months, but showed an excellent response to a second therapy session with calcitriol. One patient with rapidly progressive disease failed to respond to therapy. Our results indicate that calcitriol can be an effective agent for treating localized scleroderma in children.
In follicular keratosis of the chin, keratotic follicular papules occur on the chin and jaw due to localized prolonged pressure and friction on the naked skin. We present one patient with this disorder. The dermatoscopic examination revealed many well-demarcated yellow spindle bodies in the patchy lesion. Therapy with 1.24R-dihydroxyvitamin D3 ointment was effective during the treatment but had no residual positive effect.
Skin diseases are common in children. However, only a very few prospective epidemiologic surveys are available in the literature. The present survey was directed at determining the spectrum and pattern of skin diseases of children in Kuwait. A total of 10,000 consecutive new patients were studied; 96% were children of Arab descent. A female preponderance (52%) was observed, and infants constituted the largest group within the patient population (28.7%). A total of 162 dermatoses were recorded. Atopic dermatitis was the most prevalent dermatosis (31.3%), followed by viral warts (13.1%), alopecia areata (6.7%), pityriasis alba (5.25%), psoriasis (4%), and diaper dermatitis (4%). Atopic dermatitis was the most frequently seen dermatosis in children of all age groups, whereas, viral warts were more prevalent in school-age children. The prevalence of alopecia areata and psoriasis was higher than reported earlier in other ethnic groups. A female preponderance was seen in children with alopecia areata, psoriasis, vitiligo, acne vulgaris, contact dermatitis, and pityriasis rosea. Dermatitis, superficial cutaneous infections, and nevi/nevoid disorders were the important groups studied.
Our objective was to study skin disorders in neonates within the first 48 hours of life in Ahvaz, Iran. One thousand consecutive neonates were examined in a descriptional prospective cohort study for 1 year (2002-03). The rate of skin disorders and their relationship to age of gestation and sex were calculated and analyzed using the computerized program SPSS version 10 and chi-squared test (chi2). Our findings were Mongolian spots (71.3%), Epstein pearls (70.2%), sebaceous hyperplasia (43.7%), salmon patch (26.2%), hypertrichosis (25.7%), erythema toxicum (11.1%), milia (7.5%), desquamation (1.9%), hemangioma (1.3%), and miliaria (1.3%). The most frequent skin disorders were Mongolian spots, Epstein pearls, and sebaceous hyperplasia. Differences between our study findings and those of others may be based on racial differences and study method.
Angioblastoma usually develops in infancy or early childhood on the neck or upper trunk. It is known to be slowly progressive and benign in nature, but treatment guidelines have not yet been established. Spontaneous regression has been occasionally documented, and treatment with pulsed dye laser, excision, high-dose steroids, and interferon alpha have been successful in individual patients. Our patient experienced partial response to interferon alpha injection, and for further treatment, long-pulsed Nd:YAG laser (1064 nm) treatment was performed. However, unexpectedly, the tumor was rapidly aggravated. We report this occurrence to increase awareness of trauma-induced aggravation phenomena in angioblastoma.
The study reports the observations after propranolol therapy in 109 Chinese patients with infantile hemangioma. Response to treatment was favorable; 19 (17.4%) showed total regression, 89 (81.7%) partial regression, and 1 (0.9%) had no response. Twenty-three patients (21.1%) had some reactions, possibly due to the medication, but no life-threatening adverse effects were observed.