Table 1.
COC formulations, efficacy and safety reported in current literature
| Duration of Study | Dosage Studied | Type of Study | Efficacy Results | Safety Results | |
|---|---|---|---|---|---|
| EE and DRSP (Yasmin) | |||||
| Efficacy and safety of 3 mg DRSP/20 mcg EE oral contraceptive administered in 24/4 regimen in the treatment of acne vulgaris: A randomized, double-blind, placebo-controlled trial (Koltun et al., 2008. | Six 28-day cycle treatments (approximately 6 months) | 3 mg DRSP/20 μg EE | Randomized double-blind placebo controlled trial (sponsored study) | COC group had 4.31 odds of clear/almost clear skin as assessed by investigators after six 28-day cycles compared with placebo (p = .001) | COC group experienced three most common AEs: metorrhagia, headache, and nausea at a higher rate compared with placebo. COC group experienced one serious AE: depression (not drug-related according to authors) |
| Treatment of moderate acne vulgaris using a COC formulation that contain EE 20 μg plus DRSP 3mg administered in a 24/4 regimen: A pooled analysis (Koltun et al., 2011). | Six 28-day cycle treatments (approximately 6 months) | 3 mg DRSP/20 μg EE | Pooled analysis of two large randomized placebo-controlled clinical trials (sponsored study) | Total, inflammatory, and non-inflammatory lesion counts were more greatly reduced for COC users vs. placebo by cycle 3 and at end point (p < .0001). COC group had approximately three times odds of clear/almost clear skin by endpoint compared with placebo by investigator assessment. | N/A |
| A single-center, randomized double-blind, parallel-group study to examine the safety and efficacy of 3 mg DRSP/0.02 mg EE compared with placebo in the treatment of moderate truncal acne vulgaris (Palli et al., 2013). | Six 28-day cycle treatments (approximately 6 months) | 3 mg DRSP/20 μg EE | Randomized double-blind parallel-group study | COC group experienced significantly greater reductions in noninflammatory and total acne count by week 24 compared with placebo (p = .02). | No severe AEs were reported in the study. |
| EE and DSG (e.g., Desogen, Novial, Oilezz, Mircette) | |||||
| Effect of a DSG-containing oral contraceptive on the skin (Katz et al., 2000). | Six 28-day cycle treatments (approximately 6 months) | 50/100/150 μg DSG and 35/30/30 μg EE given in a 7/7/7-day regimen | Double-blind placebo controlled pilot study | COC group had significant reduction in sebum production on cheeks compared with placebo. No differences seen in acne lesion count between groups. Both patient and physician assessment of skin condition (VAS) significantly better in COC group. | N/A |
| Effects of biphasic oral contraceptives containing DSG (Oilezz) on cycle control facial acne and seborrhea in healthy Thai women (Wonglikhitpanya and Taneepanichskul, 2006). | 6 months | N/A | Prospective, open, non-comparative, single center study | Patients experienced significant improvements in facial seborrhea. A total of 80% of the COC group had complete clearance of acne. | No serious AEs reported |
| The effect of a phasic oral contraceptive containing DSG on seborrhea and acne (Kränzlin and Nap, 2006). | Four 28-day cycles (16 weeks) | 50/100/150 μg DSG and 35/30/30 μg EE given in a 7/7/7-day regimen | Non-randomized group-comparative trial (sponsored study) | COC users experienced statistically significant reduction in sebum production compared to controls. No difference in acne reduction. Both investigators and patients reported better skin condition in COC group (VAS). | Most common AE in COC group was headache and 26.1% of users experienced irregular bleeding during the first cycle. |
| EE and LNG (e.g., Lybrel, Alesse, Tri-levlen) | |||||
| A randomized, controlled trial of a low-dose contraceptive containing 20 microg of EE and 100 microg of levonorgestrel for acne treatment (Thiboutot et al., 2001). | Six 28-day cycles (approximately 6 months) | 20 μg of EE and 100 μg of LNG | Multicenter, randomized, double-blind, placebo-controlled clinical trial (Investigator-initiated) | By cycle 6, inflammatory, noninflammatory, and total lesion counts were significantly reduced in COC group compared with placebo (p < .05). Physician and patient assessments were also significantly better in COC group (p = .016, and p < .05). | Menorrhagia, metrorrhagia, menstrual disorder, and emotional lability was significantly higher in the COC group. One serious AE occurred in the COC group: depression (and hospitalization). |
| Efficacy of a low-dose oral contraceptive containing 20 microg of EE and 100 microg of LNG for the treatment of moderate acne: A randomized, placebo-controlled trial (Leyden et al., 2002). | Six 28-day cycles (approximately 6 months) | 20 μg of EE and 100 μg of LNG | Randomized, double-blind, placebo-controlled clinical trial | Total and inflammatory acne lesion count (p < .05) clinician and patient assessments (p < .05), and biochemical androgenicity markers were improved in COC group compared with placebo. | N/A |
| EE and CMA (e.g., Belara) | |||||
| Efficacy of an oral contraceptive containing EE 0.03 mg and CMA 2 mg (Belara) in moderate acne resolution: A randomized, double-blind, placebo-controlled Phase III trial (Plewig et al., 2009). | Six 28-day cycles (approximately 6 months) | EE 0.03 mg and CMA 2 mg | Randomized, double-blind, placebo-controlled Phase III trial (sponsored study) | Both papulopustular and comedonal acne was reduced in a significantly greater percentage of COC users compared with placebo (p < .05). Patient self-assessments were also superior in the COC group compared with placebo. | Headache, nausea, intermenstrual bleeding, breast pain, and fluor vaginalis were the most common AEs at a higher incidence in the COC group. Two severe AEs ovarian cyst (possibly related) and influenza (not related) were reported in the COC group. |
| Effects of an oral contraceptive that contains CMA and EE on acne-prone skin of women of different age groups: An open-label, single-center, phase IV study (Kerscher et al., 2008). | Six 28-day cycles (approximately 6 months) | CMA 2 mg and EE 0.03 mg | Open-label, prospective, single-center, phase IV study (sponsored study) | Statistically significant improvements in seborrhea and pore size in COC group compared with placebo after six cycles of treatment. | N/A |
| EE and NGM (e.g., Ortho Tri-Cyclen, Vivelle) | |||||
| Clinical evidence of the endocrinological influence of a triphasic oral contraceptive containing NGM and EE in women with acne vulgaris. A pilot study (Sator et al., 2003). | 28-day cycles for 6 months | NGM (0.18 mg days 1–7; 0.216 mg days 8–14; 0.25 mg days 15–21) and EE (35 μg days 1–21) | Prospective single group (investigator-initiated) | At endpoint of 6 months, sex hormone profile improved, nine out of ten patients who completed study reported improvement, acne counts were reduced, and skin surface lipids were reduced. | Two patients withdrew: One patient reported headaches and intracyclic bleeding, one patient reported exhaustion. Two subjects who completed study experienced headaches and weight gain. |
CMA, chlormadinone acetate; COC, combined oral contraceptive; DRSP, drosperinone; DSG, desogestrel; EE, ethinylestradiol; N/A, not applicable; LNG, levonorgestrel; NGM, norgestimate; VAS, visual analogue scale.