Author(s): Mango D, Ricci S, Manna P, Miggiano GA, Serra GB
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Abstract The effect of gestodene 75 micrograms (GTD) versus desogestrel 150 micrograms (DSG) combined with 30 micrograms of ethinylestradiol (EE) on acne lesions and plasma androstenedione (A), total testosterone (T), sex hormone binding globulin (SHBG) and "free androgen index" (FAI) was evaluated in an open study on 19 patients aged 18-35 years affected with postpubertal or persistent non-severe acne vulgaris. The patients were randomly allocated into two groups receiving EE-GTD (n = 8) and EE-DSG (n = 11), 21 tablets per cycle for 9 consecutive cycles. Clinical and hormonal evaluations were made between days 17-21 in the cycle before treatment and between days 17-21 of the cycle 3, 6 and 9 of treatment. During treatment, acne improved in most patients, reaching at cycle 9 a low score (absent or minimal) in 62\% of the cases in the GTD group (mean acne score = 1.25) and in 90\% of the cases in the DSG group (mean acne score = 0.90). Before treatment, about 75\% of the patients showed one or more signs of biochemical hyperandrogenism, including elevated FAI (57\%), elevated A (15\%), elevated total T (15\%) and decreased SHBG (21\%), and there was evidence of inverse correlation between SHBG and acne scores (p < 0.05). The echogenic texture of the ovaries was multifollicular in 55\% of the cases. By the end of the third cycle of treatment, the hormonal changes observed in both groups included significant decreases, with normalization of individual elevated levels of T, and a 3-fold rise of the initial values of plasma SHBG, which showed a further gradual increase at cycle 9 of EE-DSG administration. At cycle 9, normalization of the echogenic ovarian texture was observed. Acne improvement under treatments with estrogen and progestin (EP) could be significantly correlated with the normalization of biochemical hyperandrogenism. In conclusion, the biochemical and clinical efficacy of EE-GTD and EE-DSG indicate that both these preparations can be a good choice in the therapy of acne vulgaris, with a non-significant better clinical result with EE-DSG. PIP: At the Sacred Heart Catholic University in Rome, Italy, health researchers randomly allocated 19 nulligravidae aged 18-35 with either postpubertal or persistent non-severe acne vulgaris to receive either the combined oral contraceptive (OC) containing 30 mcg ethinyl estradiol (EE) and 75 mcg gestodene (GTD) (Minulet) or 30 mcg EE and 150 mcg desogestrel (DSG) (Marvelon). They aimed to evaluate the effect of GTD and DSG combined with low doses of EE on acne lesions and on hormone levels. The women used the OCs (21 tablets/cycle) for nine consecutive cycles. At baseline, about 75\% of all patients had at least one sign of biochemical hyperandrogenism (57\% for elevated free androgen index, 15\% for elevated androstenedione, 15\% for elevated total testosterone, and 21\% for reduced sex hormone binding globulin [SHBG]). At baseline, the higher the acne score was, the lower the SHBG level was (p 0.05). The ovaries of 55\% of the women had multiple follicles. Acne improved significantly in both groups (mean acne score, 2.9-0.9 for EE/DSG and 2.87-1.25 for EE/GTD; p 0.05). In fact, 62\% of cases in the EE/GTD group and 90\% of those in the EE/DSG group had either minimal or no acne lesions. Acne improvement during treatment was significantly associated with normalization of biochemical hyperandrogenism. At completion of the third cycle of treatment, both groups experienced significant decreases in hormones. Individual elevated levels of testosterone normalized. The initial values of plasma SHBG had increased 3-fold. SHBG increased gradually to cycle 9 of EE-DSG OC use. At completion of cycle 9, the echogenic ovarian texture returned to normal. These findings suggest that, since both OCs are biochemically and clinically effective, these OCs may be a good treatment for acne vulgaris.
This article was published in Contraception
and referenced in Journal of Bioequivalence & Bioavailability