Long-term (6 and 12 months) follow-up of two prospective, randomized, controlled phase III trials of photodynamic therapy with BF-200 ALA and methyl aminolaevulinate for the treatment of actinic keratosis.

BACKGROUND: Two phase III trials of photodynamic therapy (PDT) with BF-200 ALA, a recently approved nanoemulsion formulation of 5-aminolaevulinic acid (ALA) demonstrated high clearance rates in mild-to-moderate actinic keratosis (AK). The comparison to a registered methyl aminolaevulinate (MAL) cream demonstrated significantly superior total patient clearance rates. OBJECTIVES: To evaluate long-term efficacy and safety of PDT for AK 6 and 12 months after the last PDT with BF-200 ALA, MAL or placebo. METHODS: The follow-up phase (FUP) was performed with patients of two phase III studies. Both studies compared BF-200 ALA with placebo, one of the studies additionally with MAL. Overall recurrence rates and various subgroups (light source, lesion severity, lesion location, complete responders after first PDT) were assessed 6 and 12 months after the last PDT. RESULTS: Recurrence rates were similar for BF-200 ALA and MAL, with a tendency to lower recurrence rates for BF-200 ALA. The proportion of patients who were fully cleared during PDT and remained completely clear for at least 12 months after PDT were 47% for BF-200 ALA (both studies) and 36% for MAL treatment. The subgroup that was illuminated with narrow wavelength LED lamps reached 69% and 53% for BF-200 ALA (both studies, respectively) and 41% for MAL. No safety concerns were reported. CONCLUSIONS: The FUP data confirmed the high efficacy and safety of PDT with BF-200 ALA. The slightly lower recurrence rates after BF-200 ALA treatment compared with MAL treatment enhanced the better treatment outcome due to the significantly superior efficacy.

Photodynamic therapy with BF-200 ALA for the treatment of actinic keratosis: results of a multicentre, randomized, observer-blind phase III study in comparison with a registered methyl-5-aminolaevulinate cream and placebo.

BACKGROUND: Photodynamic therapy (PDT) with 5-aminolaevulinic acid (ALA) or its methylester [methyl-5-aminolaevulinate (MAL) or 5-amino-4-oxopentanoate] was recently ranked as first-line therapy for the treatment of actinic keratosis (AK) and is an accepted therapeutic option for the treatment of neoplastic skin diseases. BF-200 ALA (Biofrontera Bioscience GmbH, Leverkusen, Germany) is a gel formulation of ALA with nanoemulsion for the treatment of AK which overcomes previous problems of ALA instability and improves skin penetration. OBJECTIVES: To evaluate the efficacy and safety of PDT of AKs with BF-200 ALA in comparison with a registered MAL cream and with placebo. METHODS: The study was performed as a randomized, multicentre, observer-blind, placebo-controlled, interindividual trial with BF-200 ALA, a registered MAL cream and placebo in a ratio of 3:3:1. Six hundred patients, each with four to eight mild to moderate AK lesions on the face and/or the bald scalp, were enrolled in 26 study centres in Germany, Austria and Switzerland. Patients received one PDT. If residual lesions remained at 3months after treatment, PDT was repeated. RESULTS: PDT with BF-200 ALA was superior to placebo PDT with respect to patient complete clearance rate (78·2% vs. 17·1%; P<0·0001) and lesion complete clearance rate (90·4% vs. 37·1%) at 3months after the last PDT. Moreover, superiority was demonstrated over the MAL cream regarding the primary endpoint patient complete clearance (78·2% vs. 64·2%; P<0·05). Significant differences in the patient and lesion complete clearance rates and severity of treatment-related adverse events were observed for the narrow- and broad-spectrum light sources. CONCLUSIONS: BF-200 ALA is a very effective, well-tolerated new formulation for AK treatment with PDT and is superior to a registered MAL medication. Efficacies and adverse events vary greatly with the different light sources used.

5-Methoxypsoralen plus ultraviolet (UV) A is superior to medium-dose UVA1 in the treatment of severe atopic dermatitis: a randomized crossover trial.

BACKGROUND: Ultraviolet (UV) A1 and psoralen plus UVA (PUVA) are effective treatment options for severe atopic dermatitis (AD); however, their relative efficacy has not yet been determined in a head-to-head study. OBJECTIVES: To compare UVA1 and oral 5-methoxypsoralen (5-MOP) plus UVA with respect to efficacy, tolerability and duration of response in patients with severe generalized AD. METHODS: Forty patients were included in this randomized observer-blinded crossover trial. The patients received either 15 exposures to medium-dose UVA1 as the first treatment and, in cases of relapse, another 15 exposures to 5-MOP plus UVA as the second treatment, or vice versa. All patients were followed until 12 months after discontinuation of the last treatment. The SCORAD score was determined by a blinded investigator at baseline, after 10 and 15 treatments each and during the follow-up period. In addition, all adverse events were recorded during the whole study period. RESULTS: Twenty-three patients completed the crossover treatment. Both phototherapies resulted in clinical improvement; however, PUVA reduced the baseline SCORAD score to a significantly greater extent than UVA1 (mean +/- SD 54.3 +/- 25.7% vs. 37.7 +/- 22.8%; P = 0.041). The median length of remission was 4 weeks (interquartile range 4-12) after UVA1 and 12 weeks (interquartile range 4-26) after PUVA therapy (P = 0.012). CONCLUSIONS: PUVA provides a better short- and long-term response than medium-dose UVA1 in patients with severe AD.

European S3-guidelines on the systemic treatment of psoriasis vulgaris.

Of the 131 studies on monotherapy or combination therapy assessed, 56 studies on the different forms of phototherapy fulfilled the criteria for inclusion in the guidelines. Approximately three-quarters of all patients treated with phototherapy attained at least a PASI 75 response after 4 to 6 weeks, and clearance was frequently achieved (levels of evidence 2 and 3). Phototherapy represents a safe and very effective treatment option for moderate to severe forms of psoriasis vulgaris. The onset of clinical effects occurs within 2 weeks. Of the unwanted side effects, UV erythema from overexposure is by far the most common and is observed frequently. With repeated or long-term use, the consequences of high, cumulative UV doses (such as premature aging of the skin) must be taken into consideration. In addition, carcinogenic risk is associated with oral PUVA and is probable for local PUVA and UVB. The practicability of the therapy is limited by spatial, financial, human, and time constraints on the part of the physician, as well as by the amount of time required by the patient. From the perspective of the cost-bearing institution, phototherapy has a good cost-benefit ratio. However, the potentially significant costs for, and time required of, the patient must be considered.

Antinuclear antibodies in patients with polymorphic light eruption: a long-term follow-up study.

BACKGROUND: Previous studies have shown elevated titres of antinuclear antibodies (ANA) in 2.9-19% of patients with polymorphic light eruption (PLE). A diagnosis of lupus erythematosus (LE) was finally established in some of these ANA-positive patients. OBJECTIVES: To investigate whether the presence of ANA in patients with PLE merely represents an epiphenomenon or is associated with an increased risk of eventual progression to LE. METHODS: We identified 472 patients with PLE who had received prophylactic photo(chemo)therapy between 1986 and 2003 and were routinely tested for the presence of ANA. All ANA-positive (ANA titre of>or=1:80) patients were asked to attend for a follow-up examination comprising a medical history, complete skin inspection and a detailed laboratory analysis including ANA and antibodies against extractable nuclear antigens. RESULTS: Of all the patients, 55 (11.7%) were found to be ANA positive on one or several occasions, and three (0.6%) also had antibodies to SS-A/Ro. Thirty-nine (71%) of all ANA-positive patients including all Ro+ subjects were available for follow-up after a median follow-up period of 8 years (interquartile range 5-11.5). Twenty-five patients showed persistence of ANA positivity with a median titre of 1:160 (range 1:80-1:640), whereas in 14 patients ANA titres had returned to normal levels. None of the patients revealed additional clinical, histopathological or laboratory abnormalities suggestive of LE. CONCLUSIONS: After a median follow-up period of 8 years none of the ANA-positive patients developed LE. Our findings indicate that PLE is a benign disease without tendency to progress to LE.

A prospective, randomized, double-blind, placebo-controlled study on the influence of a hormone replacement therapy on skin aging in postmenopausal women.

BACKGROUND: There is mounting evidence that menopause affects some functions of the skin. Hormone replacement therapy (HRT) appears to limit some of the climacteric aspects of cutaneous aging. OBJECTIVE: In the light of a growing interest in the endocrinological influence of skin, we performed a study evaluating the effects of HRT on skin aging in postmenopausal women. METHODS: Forty non-hysterectomized, postmenopausal women were included in this prospective, randomized, double-blind, placebo-controlled study on the influence of oral sequential treatment with a combination of 2 mg 17beta-estradiol/10 mg dydrogesterone (Femoston) for seven 28-day cycles. Skin elasticity, skin surface lipids, skin hydration and skin thickness were measured by non-invasive methods, and both adverse-event profile and clinical-dermatological status were evaluated. RESULTS: After 7 months of HRT, skin elasticity increased significantly at the right ramus of the mandible, while skin hydration tended to improve significantly at the right upper arm (inner side); skin thickness improved significantly but skin surface lipids did not. Absolute effects did not differ significantly between HRT and placebo patients. A dermatological evaluation was largely consistent with measurement results. Safety and tolerability of HRT were positive. CONCLUSION: The results showed improvements in the parameters involved in skin aging in the HRT group as compared to baseline. While skin aging is no indication for systemic hormone supplementation, a positive effect on aging skin can be observed.

Photodegradation of folic acid during extracorporeal photopheresis.

BACKGROUND: Photodegradation of folic acid (FA) by ultraviolet (UV) radiation is a well-documented photochemical reaction, and decreased serum levels of FA have been found in patients receiving photochemotherapy (psoralen plus UVA). During extracorporeal photopheresis (ECP) leucocytes and plasma are subjected to 8-methoxypsoralen (8-MOP) plus UVA. OBJECTIVES: To investigate whether ECP leads to the photodegradation of FA in the extracorporeal system. METHODS: In 30 patients undergoing ECP on two consecutive days the FA levels were measured in the extracorporeal collected plasma prior to and after UVA exposure. Healthy donor plasma was exposed to 8-MOP and increasing doses of UVA in vitro. In five patients serum folate levels were determined before and after ECP. RESULTS: We found a mean reduction of 44% and 46% on the first and second day of treatment, respectively. This effect could be reproduced in vitro: the irradiation of healthy donor plasma with UVA led to a dose-dependent reduction of FA of up to 54.75% at 16 J cm(-2). This was independent of the presence of 8-MOP and the base concentration of 5-methyltetrahydrofolate; minimal changes were observed for vitamin B(12) and homocysteine, not undergoing photodegradation. Serum folate levels did not change significantly before and after ECP. CONCLUSIONS: We conclude that extracorporeal exposure of plasma to UVA during ECP leads to photodegradation of FA. Further investigations are required to determine the biological effects of folate photoproducts and whether clinically relevant loss of FA might be a consequence of ECP.

Review of the potential photo-cocarcinogenicity of topical calcineurin inhibitors: position statement of the European Dermatology Forum.

Topical Calcineurin Inhibitors (TCIs) used for the treatment of atopic eczema modify the immune regulatory function of the skin and may have the potential to enhance immunosuppressive ultraviolet (UV) effects. Current recommendations on UV protection in eczema patients treated with PCIs are inconsistent and have given rise to uncertainty and anxiety in patients. Therefore, the European Dermatology Forum (EDF) developed a position statement which reviews critically the available data with regard to the problem, especially analysing and commenting the limitations of rodent models for the human situation. There is no conclusive evidence from rodent trials to indicate that long-term application of TCIs is photococarcinogenic. There is a need for further studies to investigate the validity of mouse models as well as long-term cohort studies in patients using TCIs. Available data suggest that long-term application of TCIs is safe, that there is no evidence of increased skin cancer risk and that it is ethical to treat patients with TCIs when indicated.

Effects and side-effects of 2% progesterone cream on the skin of peri- and postmenopausal women: results from a double-blind, vehicle-controlled, randomized study.

BACKGROUND: For many years topical progesterone has been prescribed by gynaecologists as an antiageing and skin-firming treatment, without any clinical scientific evidence of its effects, tolerability and safety when applied to skin. OBJECTIVES: To evaluate the influence of 2% progesterone cream on function and texture of the skin in peri- and postmenopausal women. METHODS: A double-blind, randomized, vehicle-controlled study was conducted in 40 subjects. Objective methods for measuring skin elasticity, epidermal hydration and skin surface lipids, clinical monitoring and self-assessment, and determination of blood hormone levels (luteinizing hormone, follicle-stimulating hormone, oestrogen and progesterone) were used to determine effects and side-effects of this treatment at four visits over a 16-week period. RESULTS: The study demonstrated a significant (P < or = 0.05) increase of the elastic skin properties in the treatment group, as demonstrated by objective measurements of three skin elasticity parameters, whereas in the control group no such effect was observed. This effect in the treatment group was further paralleled by the results of the clinical monitoring, where the 2% progesterone cream yielded consistent superiority over vehicle in counteracting different signs of ageing in the skin of peri- and postmenopausal women. Clinical monitoring showed a greater reduction in wrinkle counts (29.10% vs. 16.50%) and wrinkle depth (9.72% vs. 7.35%) around the right eye, a greater decrease in nasolabial wrinkle depth (9.72% vs. 6.62%) and a significantly higher (P < 0.05) increase in skin firmness (23.61% vs. 13.24%) in the treatment group. Epidermal hydration and skin surface lipids did not change significantly in either group during the study. Progesterone was well absorbed in the systemic circulation: mean blood levels rose minimally, but statistically significantly (P = 0.001), by 0.53 ng mL(-1). No serious side-effects of the treatment were observed. CONCLUSIONS: The results of this study demonstrate that topical 2% progesterone acts primarily in increasing elasticity and firmness in the skin of peri- and postmenopausal women. These effects in combination with good tolerability make progesterone a possible treatment agent for slowing down the ageing process of female skin after onset of the menopause.

The course of anticoagulation after extracorporeal photochemotherapy.

During extracorporeal photochemotherapy (ECP) heparin is added to the extracorporeal circulation to avoid clotting. It has not been investigated whether and to what extend this procedure influences coagulation in patients after ECP. In this study activated partial thrombaplastin time (aPTT) and anti-factor Xa were monitored for up to 4 h after ECP in 10 patients. We found that anticoagulation followed the typical course of intravenously applied heparin: immediately after reinfusion anti-Xa was high (>1 IU/ml) and aPTT was prolonged to more than 180 s followed by a rapid decline and reaching normal values within 3-4 h in all patients. We conclude that anticoagulation and increased risk of bleeding after ECP is confined to a short period immediately following treatment. Physicians using ECP should be aware of the course of anticoagulation associated with this treatment.

Ultraviolet protective performance of photoprotective lipsticks: change of spectral transmittance because of ultraviolet exposure.

BACKGROUND: Photoinstability of sunscreens because of ultraviolet (UV) exposure is a well-known and common phenomenon. Recently, it was also shown that sunscreens with complex filter combinations are photoinactivated by UV exposures, which can easily be acquired by solar exposure over several hours. OBJECTIVES: To assess the change of the spectral transmission after UV exposure (UV-challenged protective performance) of 27 commercially available photoprotective lipsticks. METHODS: Quartz slides were covered with a lipstick layer (area density 1.0+/-0.1 mg/cm2) and irradiated with increasing doses of solar-simulated radiation. The spectral transmission (T) was measured spectrophotometrically before and after 5, 12.5, 25, and 50 standard erythema doses (SED) of exposure. We calculated the change in transmission (photoinstability) as the difference between the spectral transmission before and after a defined UV exposure, DeltaT, and the arithmetic mean, for both the UVA (DeltaTA) and UVB (DeltaTB) ranges. A product was labelled as photounstable if the mean photoinstability in the UVA, DeltaTA, or UVB range, DeltaTB, was higher than 5% for an UV exposure of 12.5 SED. RESULTS: Eleven products showed a significant photoinstability in the UVA range (DeltaTA between 6% and 27%), only one product in the UVB range (DeltaTB = 13%), and one product in both the UVA (DeltaTA = 31%) and UVB (DeltaTB = 9%) range. In one product photoinstability became significant in the UVA range at higher UV exposures. CONCLUSIONS: Out of 27 lipsticks only 13 products showed a photostable performance (DeltaTA < 5% and DeltaTB < 5% for 12.5 SED). We propose therefore that only products, which fulfil these UV photostability criteria should be marketed.

Topical aminolaevulinic acid-based photodynamic therapy as a treatment option for psoriasis? Results of a randomized, observer-blinded study.

BACKGROUND: Topical aminolaevulinic acid-based photodynamic therapy (ALA-PDT) has recently been tried in small open studies for several inflammatory dermatoses including psoriasis. OBJECTIVES: The purpose of this randomized, within patient comparison study was to investigate whether topical ALA-based PDT using a range of light doses can induce a satisfactory response in localized psoriasis. PATIENTS AND METHODS: Twenty-nine patients with chronic plaque type psoriasis were enrolled in the study. After keratolytic pretreatment three psoriatic plaques in each patient were randomly allocated to PDT with 1% ALA and a light dose of 5 J cm(-2), 10 J cm(-2) or 20 J cm(-2), respectively. Treatment was performed twice weekly until complete clearance or for a maximum of 12 irradiations. As a measure of clinical response the psoriasis severity index (PSI) of the three target plaques was assessed separately by an observer blinded to the treatment at baseline, before each PDT treatment and 3-4 days after the last irradiation. RESULTS: Eight patients withdrew prematurely from the study. Keratolytic pretreatment alone reduced the baseline PSI in all three dose groups by about 25%. Subsequent PDT with 20 J cm(-2) resulted in a final reduction of PSI by 59%, PDT with the lower doses of 10 J cm(-2) and 5 J cm(-2) decreased the baseline PSI by 46% and 49%, respectively. The difference in clinical efficacy between 20 J cm(-2) and 10 J cm(-2) or 5 J cm(-2) was statistically significant (P = 0.003; P = 0.02), whereas no difference was found between 10 J cm(-2) and 5 J cm(-2) (P = 0.4). All patients reported some degree of PDT-induced stinging or burning during irradiation. CONCLUSIONS: The unsatisfactory clinical response and frequent occurrence of pain during and after irradiation renders topical ALA-based PDT an inadequate treatment option for psoriasis.

The oak processionary caterpillar as the cause of an epidemic airborne disease: survey and analysis.

BACKGROUND: Thaumetopoea processionea L. (order Lepidoptera), the oak processionary moth, is found in oak forests in most European countries. Its third to sixth larval instars are armed with poisonous hairs (setae) containing an urticating toxin (thaumetopoein) potentially harmful to humans. Because T. processionea infests trees at the edges of forests or standing alone people frequently come into contact with its setae. In the woodland bordering on the western suburbs of Vienna conditions favouring its increase have led to frequent outbreaks of lepidopterism. OBJECTIVES: To determine the incidence of lepidopterism in a suburban environment with three separate caterpillar-infested oak trees and to ascertain the frequency of the various symptoms of lepidopterism and the manner of contact with setae. METHODS: We conducted a telephone survey of all the households/institutions located within 500 m of the infested trees. To gain more information on patients' symptoms and on situations likely to lead to increased contact with setae we asked those who reported cutaneous reactions to complete a questionnaire. As part of the environmental study we described the outbreak site, examined patients and, with tape-strip samples taken from the surface of the soil, looked for setae persisting in the environment. RESULTS: Of 1025 people surveyed 57 (5.6%) reported one or more symptoms of lepidopterism: 55 (96%) reported pruritus, 54 (95%) dermatitis, eight (14%) conjunctivitis, eight (14%) pharyngitis and two (4%) respiratory distress. The questionnaire was returned by 37 (69%) of the individuals with dermatitis. Of those, 16% had reacted with weal formation, 49% with papular rash and 22% with toxic irritant dermatitis. In 13% of respondents it was not possible to define the reaction. The risk factor analysis showed that airborne contamination was the most important cause: 97% of people had frequently passed an infested tree, 57% lived near a tree (in a neighbouring garden) and 32% had a tree in their own garden. Direct contact with larvae was of minor importance (38%). In four of the tape-strip samples intact setae were identified 1 year after the infestation. CONCLUSIONS: Lepidopterism caused by T. processionea is a public health problem of increasing significance. In years with outbreaks of the pest it can reach epidemic proportions in communities located near infested trees. Contact with airborne setae was mainly responsible for the occurrence of the disease.

Observer-blind, randomized, intrapatient comparison of a novel 1% coal tar preparation (Exorex) and calcipotriol cream in the treatment of plaque type psoriasis.

BACKGROUND: In a recent pilot study a novel, patented fatty acid-based 1% coal tar preparation (Exorex) has been found to be similar in efficacy to calcipotriol in the treatment of psoriasis. OBJECTIVES: Our aim was to investigate the therapeutic efficacy, safety and cosmetic acceptability of the new 1% coal tar preparation in comparison with calcipotriol cream in a larger patient cohort. PATIENTS AND METHODS: Forty patients with chronic plaque type psoriasis were included in this randomized, observer-blind, intrapatient comparison trial. In each patient two comparable target plaques were treated twice daily with 1% coal tar preparation or calcipotriol cream. At the onset of therapy and at weeks 2, 4, 6 and 8, the response to treatment was determined by the psoriasis severity index (PSI) that assesses the degree of erythema, infiltration and scaling of the psoriatic lesions on a five-point scale. In addition, all treatment-related side-effects were recorded and cosmetic acceptability of both treatments was rated every second week by the patients. After complete or near complete clearing the patients were followed up until relapse or for a maximum period of 18 months. RESULTS: Thirty-eight patients completed the study. At termination of the trial the mean +/- SD baseline PSI score of 9.2 +/- 1.5 was reduced to 3.0 +/- 2.9 by 1% coal tar preparation and to 2.8 +/- 2.7 by calcipotriol. The mean PSI reduction between baseline and final assessment did not differ significantly between 1% coal tar preparation and calcipotriol (P = 0.77). The mean intraindividual difference in reduction of PSI score between 1% coal tar preparation and calcipotriol was 0.1 score points (95% confidence interval - 0.84 to + 0.63). No difference between either preparation was observed with regard to time until relapse. Itching was caused by 1% coal tar preparation in four patients and by calcipotriol in one patient. Unpleasant odour or staining of the 1% coal tar preparation was reported by six patients, whereas one patient complained about the smell of the calcipotriol cream. CONCLUSIONS: The novel 1% coal tar preparation was found to be comparably as effective as calcipotriol in treating psoriasis. Tolerability and cosmetic acceptability was better for calcipotriol. Taking into consideration that the coal tar preparation is considerably less expensive than calcipotriol this new product appears as a very useful topical medication for chronic plaque type psoriasis.

Assessment of thickness of photoprotective lipsticks and frequency of reapplication: results from a laboratory test and a field experiment.

BACKGROUND: The thickness of the sunscreen layer that is actually applied by consumers under usual conditions has been determined for photoprotective lotions and creams; however, this question is still unanswered for photoprotective lipsticks. OBJECTIVES: To assess lipstick thickness (area density) and frequency of application per day for two commercially available photoprotective lipsticks with different consistency. METHODS: The study consisted of a laboratory test and a field experiment. In the laboratory test the applied lipstick thickness was determined as area density in mg cm(-2) for a group of 28 panellists under standardized conditions. In a separate group of 18 subjects we assessed the area density and the frequency of application per day for two photoprotective lipsticks during a 6-day skiing course. RESULTS: In the laboratory test the median and 95% confidence interval of the area density was 0.98 mg cm(-2) (0.66-1.65) and 0.86 mg cm(-2) (0.63-1.40) for products A and B, respectively. The respective values of the field experiment were 1.58 mg cm(-2) (0.79-2.23) (product A) and 1.76 mg cm(-2) (1.16-3.50) (product B). Only 11% of all applications of lipstick A and 6% of all applications of lipstick B reached the reference area density of 2.0 mg cm(-2). The difference between the median of the area density for lipstick A (firm consistency) and lipstick B (soft consistency) was not statistically significant. No statistically significant influence on the area density was found for age, sex, photobiological skin type or regular lipstick use. The median daily frequency of application was 2.2 times for lipstick A and 3.0 times for lipstick B. CONCLUSION: Our investigation shows that photoprotective lipsticks are applied in a much thinner layer than recommended by international standards (2 mg cm(-2)). This results in a significant reduction of the photoprotective capacity. Furthermore, the frequency of application is too low for adequate protection. Therefore, we propose that the sun protection factor (SPF) should be assessed for an area density that reflects the actual usage patterns. As long as the test protocol is not adapted to the reduced area density, photoprotective lipsticks with high and ultrahigh SPF should be recommended, especially for individuals with increased risk for the development of lip malignancies.

Clinical evidence of the endocrinological influence of a triphasic oral contraceptive containing norgestimate and ethinyl estradiol in treating women with acne vulgaris. A pilot study.

BACKGROUND AND OBJECTIVE: The aim of this study was to evaluate the efficacy of a triphasic combination oral contraceptive (OC) containing norgestimate and ethinyl estradiol in the treatment of women with acne vulgaris. METHODS: 12 female patients were included and 10 completed the trial. Over a period of 6 months, efficacy was assessed by means of facial acne lesion counts, by an investigator's global assessment, by patients' self-assessments and by measuring epidermal moisture and skin surface lipids. In addition, a photo documentation was compiled and hormone levels were measured. RESULTS: After 6 months of therapy, the number of acne counts improved. The success of treatment was rated positively both by the investigator and by all patients but one who did not report any changes. Skin surface lipids were significantly reduced while skin hydration showed no significant change. Testosterone and progesterone decreased, and sex-hormone-binding globulin increased, significantly. CONCLUSION: Our data show that an OC containing norgestimate and ethinyl estradiol is a good therapeutic option for women of fertile age suffering from mild to moderate acne vulgaris.