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Seborrhea
Contraception 68 (2003) 239 –245
Original research article

Effects of a phasic oral contraceptive containing
desogestrel on facial seborrhea and acne

V.N. Prilepskayaa, V.N. Serovb, E.V. Zharovb, I.J. Golousenkob, E.A. Mejevitinovaa, E.V. Gogaevaa, V.V. Yaglova, O.N. Golubevab
aScientific Center of Obstetrics, Gynecology and Perinatology, Russian Academy of Medical Science, Moscow, Russia
bMoscow State Medico-Stomatological University, Moscow, Russia

Received 23 October 2002; received in revised form 16 June 2003; accepted 23 June 2003

Abstract

Background: The combined oral contraceptive containing ethinylestradiol and the selective progestogen, desogestrel, in a phasic regimen (DSG-OC, Tri-merci.) has been shown to reduce facial oiliness.

Objective: This study was designed to evaluate further the effects of this OC on the skin of women with facial seborrhea and mild or moderate acne.

Design and methods: This was an open, noncomparative, bicenter study in 60 healthy Russian women, aged 18 –30 years, with facial seborrhea and mild or moderate facial acne, who wished to use oral contraception. All women received the OC containing desogestrel (50/100/150 .g) and ethinylestradiol (35/30/30 .g) for three phases of 7 days followed by a 7-day pill-free interval, for six cycles. Seborrhea was assessed using the Sebutape technique, in which strips of adhesive microporous polymeric film pressed onto facial sites are used to assess sebaceous activity. Acne was assessed by counting facial lesions. Subjective evaluations of skin and hair condition, patients’ feelings to them and satisfaction with the OC were made using a visual analogue scale (VAS). Assessments were made at baseline, and after one, three and six treatment cycles.

Results: Sebutape assessments of seborrhea were significantly improved, on the right and left cheeks, after one treatment cycle, and on the forehead after three treatment cycles. These improvements increased steadily and were much larger at the end of Cycle 6. Acne grades were significantly improved after three and six treatment cycles. VAS scores in response to questions dealing with self-esteem and self-confidence were significantly improved after three cycles and in some cases after just one cycle. The women’s views of their skin and hair (greasiness) were correspondingly significantly improved. Subjective assessments indicated that after one, three and six cycles, 69%, 93% and 98%, respectively, of women were satisfied or very satisfied with the DSG-OC.

Conclusion: In women with facial seborrhea and mild or moderate acne, the use of DSG-OC appears to improve seborrhea after just one cycle and acne grades after three cycles. These improvements are accompanied by increases in self-esteem and confidence. © 2003 Elsevier Inc. All rights reserved.

1. Introduction

The overproduction of sebum by the sebaceous glands resulting in greasy or oily skin and hair is a common condition, particularly in teenagers, and affects two thirds to three quarters of this group [1,2]. Seborrhea is also a major contributory factor in the development of acne and can be considered a precondition for acne [3,4]. Acne also affects a high proportion of teenage girls, although survey estimates vary from about half of 14 –16-year-olds [5] to 80– 90% of 13–18-year-olds [6] and as many as 40% of women aged 25– 40 years [7]. Surveys indicate that, like acne, seborrhea itself has a negative effect on self-esteem and self-confidence of women. Physicians, however, view skin conditions as less important than do women, and give relatively low priority to treating it [1,2].

The oral contraceptive DSG-OC, which contains ethinylestradiol and desogestrel in a triphasic regimen, is a safe and effective contraceptive [8]. Desogestrel is a highly selective progestogen with minimal androgenic activity compared with other synthetic progestogens [9]. Thus, DSG-OC presents a favorable balance between estrogenic and androgenic effects and results in correspondingly increased levels of serum sex hormone-binding globulin and decreased percentages of free testosterone [10]. Free androgens, such as testosterone, bind to receptors in the sebaceous glands and stimulate the secretion of sebum. The reported favorable effects of a desogestrel-contain-ing monophasic OC (150 .g desogestrel and 30 .g ethinylestradiol) on seborrhea [11] and acne [11–15] are considered to be due to the low androgenicity of desogestrel. DSG-OC has also been found to have favorable effects on the skin, producing a reduction in facial oiliness in a double-blind placebo-controlled study of groups of 41 women [10].

This study was designed to evaluate further the effects of a phasic OC containing desogestrel on the skin of women with facial seborrhea and mild or moderate acne.

2. Methods

2.1. Participants

The inclusion criteria were age between 18 and 30 years, a body mass index of 18–29 kg/m2, otherwise healthy. Women should have facial seborrhea (oily skin) and/or mild to moderate acne (see definitions below), and should wish to use oral contraception.

Exclusion criteria included a history of severe acne, contraindications for oral contraceptives, a cycle length of .21 or .35 days prior to first pill use; use of systemic anti-acne treatments and/or Diane. within 2 months before the study; use of contraceptive implants and IUDs within 1 month before the study; use of hormonal contraceptives and sex steroids other than oral contraceptives within one cycle before the study; pregnancy within 2 months before the study; participation in another trial within 30 days before the study; and any other disorder in the pretreatment period that was considered relevant by the investigator.

All participants gave written informed consent. The study was approved by local Ethics Committees.

2.2. Study design and treatment

This was an open-label, noncomparative, bicenter trial performed in Russia. All women received one tablet a day of Tri-merci(Laurina., Novial., Trimiron.; N.V. Organon, Oss, The Netherlands) containing 50/100/150 .g desogestrel plus 35/30/30 .g ethinylestradiol for three phases of 7 days followed by a 7-day pill-free interval, for six cycles.

2.3. Assessments

Assessments were done before treatment, and after one, three and six cycles of treatment.

Medical, skin and gynecological histories were taken and physical and gynecological examinations, including pretreatment signs and symptoms and cervical cytology, were done at the pretreatment visit. A gynecological examination was also done at the final visit. Bleeding data, Sebutape(DuDerm Corp, Dallas, TX, USA) assessments, a nonvalidated skin/hair questionnaire and counting skin lesions, and drug and concomitant medication assessments were done at the pretreatment visit and at the end of Cycles 1, 3 and 6. Adverse events were noted at the end of Cycles 1, 3 and 6.

Sebum output was assessed on the forehead and cheeks using Sebutape strips, made of adhesive microporous polymeric film. Sampling sites were cleansed with detergent (Tri-ton-X-100), defatted using hexane and allowed to dry before the tapes were gently pressed onto the facial sites. After1hthe strips were gently removed and placed on black storage cards (with each tape placed on the appropriate area of a facial diagram). The samples were compared visually with reference patterns, and graded from 0 to 5 [10,16].

Acne was assessed by counting the acne lesions (comedones, papules, pustules, nodules) on the face and divided into four severity categories which were: none (no visible lesions); mild [maximum of five comedones or papules and no inflamed lesions (pustules)]; moderate [6–15 comedones or papules and/or a maximum of three inflamed lesions (pustules)]; severe [more than 15 comedones or papules and/or more than three inflamed lesions (pustules) and/or any nodules].

Subjective evaluations of the condition of the facial skin, and of patients’ reactions to their skin condition, were made using a visual analogue scale (VAS), on a questionnaire. Scores ranged from 1 to 10, where 1 was the least favorable and 10 was the most favorable score.

Adverse events were reported in response to a nonspecific question at each evaluation.

2.4. Statistics

Changes in mean weight, blood pressure, responses to skin/ hair questionnaire, sebum production and acne lesion counts were analyzed by the Friedman test to assess overall changes with time. Changes in questionnaire results, sebum production and acne lesion counts were also compared with baseline in the Newman–Keuls test. Changes in user satisfaction and vaginal bleeding patterns were analyzed by the McNemar X2 test.

3. Results

3.1. Study population

Of the 60 women enrolled in the study, 3 discontinued, 1 because of weight change, 1 because of a family objection and 1 because she no longer needed contraception. As a result, there were 60 women in the analysis at baseline, 58 at Cycle 1, and 57 at Cycles 3 and 6. Two women with severe acne were enrolled in violation of the protocol.

Those enrolled ranged in age from 18 to 30 years, with a mean (SD) of 23.1 (3.7). There were no statistically significant changes in body weight or blood pressure during the study.


Fig. 1. Sebum output by women using desogestrel-containing phasic OC, assessed by the Sebutape technique. Range from Grade 1 (i.e., sparsely distributed spots representing low sebum activity) to 5 (i.e., densely distributed spots representing high sebum activity). *p < 0.05; #p < 0.0001 compared with baseline (Wilcoxon matched pairs test)


Fig. 2. Semi-quantitative analysis of acne vulgaris in women using desogestrel-containing phasic OC. *p < 0.01; #p < 0.0001 compared with baseline (Wilcoxon matched pairs test)

3.2. Vaginal bleeding pattern

The percentage of women with spotting or bleeding increased after Cycle 1, compared with baseline and gradually decreased during subsequent cycles. At Cycle 1, 7 (12%) of the 58 women had spotting or bleeding but by Cycle 6 only 1 woman was affected, though the difference between Cycles 1 and 6 was not statistically significant (p=0.08).
3.3. Skin and hair data

Statistically significant improvements in facial seborrhea grades (as indicated by the Sebutape assessments) were found after Cycle 1 in the case of the right and left cheeks (p<0.05), and after Cycle 3 in the case of the forehead (p<0.0001). These improvements increased steadily and were much larger after Cycle 6; forehead and both cheeks showed the same improvements (Fig. 1). The majority of women (78%, 63% and 62% for the forehead, left and right cheeks, respectively) had seborrhea grades of 3 or above at baseline, whereas the majority (87%, 93% and 91%) had seborrhea grades of 1 and 2 by Cycle 6. By Cycle 6, none of the women had seborrhea grades of 4 or 5 at any of the three sites.

There were also statistically significant improvements in acne grades at Cycles 3 and 6 compared with baseline (p<0.01; Fig. 2). The severity of acne declined steadily, such that the percentage of women with mild or no acne increased from 25% at baseline, to 36% at Cycle 1, 54% at Cycle 3 and 75% at Cycle 6

Women’s subjective ratings of the appearance of their skin showed significant improvements from Cycle 1 (p<0.001) and their views on the frequency with which they had acne were significantly improved by the end of Cycle 1 (p<0.05). Women’s ratings of their skin oiliness, acne lesions and hair condition also showed the same steady improvements throughout the study. Similarly, at each assessment, there were improvements in the women’s scores for lack of confidence or self-esteem, and for feelings of unattractiveness because of their skin condition. In many cases, significant improvements could be seen after just one treatment cycle. These improvements continued until the end of Cycle 6 (Fig. 3).
3.4. User satisfaction and recommendation

Subjective assessments showed that after Cycles 1, 3 and 6, 69%, 93% and 98% of the women, respectively, were satisfied or very satisfied with the DSG-OC (Fig. 4). By Cycle 6 there was a statistically significant improvement in the proportion of women who were very satisfied or satisfied compared with Cycle 1 (p<0.0004). At the end of the study, 68% of women said they would definitely like to continue using this contraceptive and another 30% said they would probably like to continue with it, while 96% would definitely or probably recommend it to a friend.
3.5. Adverse events

No serious adverse events were reported. In total, 18 subjective side effects were reported throughout the study; these included nausea, headache, breast tenderness, body weight increase, mood changes and decrease in libido.

4. Discussion

The present results indicate that DSG-OC has a significant effect on facial sebum secretion even after one cycle, and appears also to have a favorable effect on the presence and severity of acne lesions by the end of three cycles of treatment. The questionnaire results confirm the importance of skin condition to women; seborrhea had a negative effect on women’s self-esteem and self-confidence, which were steadily improved during DSG-OC use in tandem with their skin condition. It has to be taken into consideration that the VAS questionnaire was nonvalidated and therefore the results have to be treated with caution. Nevertheless, there was a steady decline in subjective symptom severity in all questionnaire items throughout the study.

The Sebutape method is an established technique for determining sebum excretion on the skin surface [17]. The sebum output collected using Sebutape can be estimated by visual inspection and comparison with reference patterns, as in the present study, but more quantitative results have been obtained using computerized image analysis or colorimetry [10,17]. Although this study used a semi-quantitative grading system, which may be less detailed than lesion counts, the magnitude of the change found is sufficient to establish an effect. In a previous study, changes in sebum output as estimated by semi-quantitative image analysis were broadly consistent with those indicated by qualitative reference pattern analysis [10].

The results of the current study are consistent with those of Katz et al. [10] in showing a reduction in sebum production on the cheeks and forehead in women taking DSG-OC. In the current study, the majority of women had seborrhea assessments of Grade 3 or 4 at baseline and of Grade 1 or 2 at the end of Cycle 6. These changes in sebum production appear to have been considerably larger than those in the earlier study [10]. This difference may be partly attributable to a placebo effect, in addition to the treatment effect, in the present intra-group comparison. A strong placebo effect has previously been reported in acne studies, possibly resulting at least partly from improved skin care associated with participation in such studies [10,18]. Nevertheless, the steady improvements in skin condition, in the present study, add to the existing evidence that DSG-OC is beneficial for women with seborrhea and is a suitable contraceptive for many young women. Seborrhea is a common condition mainly affecting young women, the prevalence of which is sometimes underestimated by physicians [1,2]. Survey data show that gynecologists and general practitioners indicate that they have tended to give seborrhea treatment low priority, considering treatment only when asked to do so by women, if the condition was severe, or if spots were also present [1,2]. In the same surveys 66–75% of the women aged 15–20 years considered that they had some degree of seborrhea and many reported negative feelings as a result of their greasy skin. Seborrhea may thus reduce self-esteem and self-confidence, and have a negative impact on the quality of life of many young women. The present questionnaire results are consistent with this view and further indicate that using phasic DSG may reduce seborrhea and consequently increase self-esteem and self-confidence of women who are affected.

Seborrhea and acne are undoubtedly closely linked and seborrhea is among the factors that lead to acne [4]. This close relationship suggests that the psychological benefits of reducing seborrhea itself will be matched by beneficial effects on the development of acne. In the present study the phasic OC appears to have resulted in a significant reduction in the severity of acne after three cycles.

In conclusion, facial seborrhea appears to improve significantly even after just one treatment cycle with DSG-OC and this improvement appears to continue steadily during subsequent cycles, though a placebo effect may account for some of the improvement seen in the present study. DSG-OC also seems to lead to a significant improvement in acne after three treatment cycles. Women’s self-esteem and confidence improved alongside the improvements in their skin condition during DSG-OC use.


Fig. 3. Feelings about skin condition in women using desogestrel-containing phasic OC. A higher score indicates an improvement (1=least favorable; 10=most favorable). *p<0.05; **p<0.01; ***p<0.001 compared with baseline (Wilcoxon matched pairs test).


Fig. 4. Satisfaction with the desogestrel-containing phasic OC after one, three and six treatment cycles. The proportion of women who were satisfied or very satisfied increased significantly by the end of Cycle 6 compared with Cycle 1 (p=0.0004, McNemar X2 test).


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