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ABSTRACT: Actinic keratoses (AK) are squamous cell carcinomas in situ and require treatment. Betulin-based oleogel prepared from a standardized triterpene dry extract from birch bark represents a new topical agent with anti-inflammatory and anti-tumor potential.
In the prospective, randomized, monocentric phase 2a study 45 patients with < 10 AK were included and randomly assigned to one of the three treatment groups. Intervention consisted of topical betulin-based oleogel twice daily versus cryotherapy with liquid nitrogen versus the combination of cryotherapy with topical betulin-based oleogel. Treatment response was assessed clinically after three months. The clinical response was graded into complete clearing (100 %), therapy responders (> 75 % clearing of the lesions) and non-responders (< 75 % clearing). Additionally, punch biopsies were obtained from some patients before and at the end of treatment.
Therapy with betulin-based oleogel was well tolerated.Three patients discontinued therapy because of personal reasons. After three months, the 100% (and > 75%) clearing rates of the lesions were as follows: 64% (86%) with betulin-based oleogel (n = 14),79% (93%) with cryotherapy (n = 14),and 71% (71%) with the combined therapy (n = 14). Histological analysis of biopsies taken before and after treatment (n = 8) showed a reduced degree of dysplasia in the epidermis in all study arms.
Betulin-based oleogel seems to be an effective novel approach in the topical treatment of actinic keratoses. However,the clinical and histological findings of the present pilot study have to be verified against placebo with larger case numbers.
Journal der Deutschen Dermatologischen Gesellschaft 09/2008; 7(2):128-33. · 1.47 Impact Factor
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ABSTRACT: Coriander oil is used as an antimicrobial agent and as a natural fragrance. The present study investigated the anti-inflammatory potency of coriander oil in the ultraviolet (UV) erythema test in vivo.
40 volunteers were enrolled in this monocentric,randomized,placebo-controlled double-blind study.Test areas on the back were irradiated with the 1.5 fold minimal erythema dose UV-B. Subsequently, the test areas were treated under occlusion for 47 hours with a lipolotion containing 0.5% or 1.0% essential coriander oil. Hydrocortisone (1.0%) and betamethasone valerate (0.1%) in the vehicle served as positive controls.The vehicle was used as place-bo.The effect of the test substances on the UV-induced erythema was measured photometrically after 48 hours.Additionally,the skin tolerance of the test preparations was assessed on non-irradiated skin.
Compared to placebo, the lipolotion with 0.5% coriander oil significantly reduced the UV-induced erythema, but it was not as effective as hydrocortisone. The skin tolerance of both coriander oil concentrations was excellent.
The lipolotion containing coriander oil displayed a mild antiinflammatory effect in this study. It could be useful in the concomitant treatment of inflammatory skin diseases.
Journal der Deutschen Dermatologischen Gesellschaft 04/2008; 6(10):847-51. · 1.47 Impact Factor
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ABSTRACT: Plants of the Schisandraceae family contain a variety of pharmacologically active lignans like schizandrin, deoxyschizandrin, deangeloylgomisin B, gomisin A, gomisin O, gamma-schizandrin and isogomisin O. Here we have compared the composition of different polar and non-polar extracts of Schisandra sphenanthera and Schisandra chinensis. We also have screened the extracts for antiproliferative and anti-inflammatory effects in different cell-based and cell-free assays. Extracts produced with the non-polar solvents CO(2), hexane and CO(2)/5% ethanol had a similar composition. In contrast, polar extraction with ethanol provided a considerably higher yield, but a lower content of volatiles and lignans in comparison to the non-polar extracts. The proliferation of the epidermal cell lines HaCaT and A431 was dose-dependently inhibited by both the Schisandra sphenanthera and Schisandra chinensis extracts, the non-polar extracts being superior to the polar ones. The non-polar Schisandra sphenanthera extract was the most active with a half-maximal inhibitory concentration of 20 microg/mL. In a cell-free enzyme inhibition assay with recombinant cyclooxygenase-2 (COX-2) the non-polar Schisandra sphenanthera extract dose-dependently inhibited COX-2 catalysed prostaglandin (PG) production (IC(50) = 0.2 microg/mL). It also reduced the ultraviolet-B (UVB)-induced PGE (2) production (IC(50) = 4 microg/mL) and COX-2 expression in HaCaT keratinocytes. We conclude that non-polar SChisandra extracts obtained by CO(2) extraction might be useful in the prevention and treatment of hyperproliferative and inflammatory skin diseases.
Planta Medica 09/2007; 73(10):1116-26. · 2.15 Impact Factor
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ABSTRACT: Birch bark contains a variety of apoptosis-inducing and anti-inflammatory substances such as betulinic acid, betulin, oleanolic acid and lupeol. Therefore, birch bark extract may be effective in the treatment of actinic keratoses. To address this issue, a pilot study using a standardized birch bark ointment was performed.
Twenty-eight patients with actinic keratoses were enrolled in this prospective, non-randomized pilot study. Fourteen patients were treated with birch bark ointment only; fourteen patients received a combination therapy with cryotherapy and birch bark ointment. Treatment response was assessed clinically after two months.
Clearing of more than 75 % of the lesions was seen in 79 % of the patients treated with birch bark ointment monotherapy. The response rate of the combined treatment modality was 93 %. Therapy with birch bark ointment was well tolerated.
In this pilot study, a standardized birch bark extract was effective in the treatment of actinic keratoses. This therapy is easy to perform and it has no side effects. Birch bark ointment may be a new therapeutic option for actinic keratoses.
Journal der Deutschen Dermatologischen Gesellschaft 03/2006; 4(2):132-6. · 1.47 Impact Factor
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ABSTRACT: Background: Birch bark contains a variety of apoptosis-inducing and anti-inflammatory substances such as betulinic acid, betulin, oleanolic acid and lupeol. Therefore, birch bark extract may be effective in the treatment of actinic keratoses. To address this issue, a pilot study using a standardized birch bark ointment was performed.Methods: Twenty-eight patients with actinic keratoses were enrolled in this prospective, non-randomized pilot study. Fourteen patients were treated with birch bark ointment only; fourteen patients received a combination therapy with cryotherapy and birch bark ointment. Treatment response was assessed clinically after two months.Results: Clearing of more than 75 % of the lesions was seen in 79 % of the patients treated with birch bark ointment monotherapy. The response rate of the combined treatment modality was 93 %. Therapy with birch bark ointment was well tolerated.Conclusion: In this pilot study, a standardized birch bark extract was effective in the treatment of actinic keratoses. This therapy is easy to perform and it has no side effects. Birch bark ointment may be a new therapeutic option for actinic keratoses.ZusammenfassungHintergrund: Birkenkork ist reich an Triterpenen (Betulin, Betulinsure, Oleanolsure, Lupeol, Erythrodiol), für die Apoptose induzierende und antientzündliche Wirkungen beschrieben sind. Deshalb könnte sich ein Extrakt aus Birkenkork für die Therapie von aktinischen Keratosen eignen. Mit der hier untersuchten Birkenkork-Creme liegt erstmals eine galenische Formulierung vor (Birkenkorkextrakt, pflanzliche Öle, Wasser), in der die Wirkstoffe des Birkenkorks in therapeutisch ausreichender Menge vorhanden sind.Methoden: Im Rahmen der prospektiven, nicht randomisierten Pilotstudie wurden 28 Patienten mit aktinischen Keratosen behandelt. 14 Patienten erhielten eine Creme mit Birkenkorkextrakt als Monotherapie, 14 Patienten wurden zustzlich kryotherapeutisch behandelt. Die Birkenkork-Creme wurde von den Patienten zweimal tglich aufgetragen. Das klinische Ansprechen wurde nach zwei Monaten erfasst.Ergebnisse: Bei Behandlung mit Birkenkorkextrakt als Monotherapie zeigten 79 % der Patienten nach einem Beobachtungszeitraum von zwei Monaten eine klinische Abheilung von über 75 % der Lsionen. Bei der Kombinationsbehandlung mit Kryotherapie kam es bei 93 % der Patienten zu einem Ansprechen auf die Behandlung. Die Vertrglichkeit der Birkenkork-Creme war in allen Fllen sehr gut.Schlussfolgerung: Im Rahmen dieser Pilotstudie zeigte die lokale Anwendung eines standardisierten Birkenkorkextraktes eine gute Wirksamkeit bei der Behandlung aktinischer Keratosen. Die Anwendung ist einfach und die Vertrglichkeit sehr gut. Deshalb stellt Birkenkorkextrakt eine interessante neue Therapieoption für aktinische Keratosen dar.
Journal der Deutschen Dermatologischen Gesellschaft 01/2006; 4(2). · 1.47 Impact Factor
