Abstract | BACKGROUND: OBJECTIVE: In this study, we sought to evaluate the safety and efficacy of 3mg DRSP/0.02 mg EE versus placebo in the treatment of truncal acne in women.<BR> METHODS: Females, age 18-45, with 10 to 50 truncal acne lesions, were randomized in this double-blind study to 3mg DRSP/0.02 mg EE (n=15) or placebo (n=10) administered in a 24/4 regimen given for 24 weeks. Noninflammatory, inflammatory and total truncal acne lesion counts were assessed from baseline to endpoint and mean percent change compared. Investigator Global Assessment ( IGA) and Subject Global Assessment (SGA) were assessed based on scoring scales, and the percentage of subjects rated as success with clear (score 0) or almost clear (score 1) were computed.<BR> RESULTS: The 3mg DRSP/0.02 mg EE group had significant reductions in mean percent change in noninflammatory, inflammatory and total lesions by 52.1%, 53.2%, and 57.3%, respectively, compared to placebo with -9.2%, 18.2% and 17.0 %, respectively, by week 24 (p = 0.02, 0.05 and 0.02, respectively). The percentage of subjects on 3mg DRSP/ 0.02 mg EE rated as treatment success were 53.3% and 60% based on IGA and SGA respectively. The regimen was also well tolerated by patients.<BR> CONCLUSIONS: 3mg DRSP/ 0.02 mg EE is a safe and significantly effective treatment for moderate truncal acne.
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Authors | Ma Beatrice Alora Palli, Claire Marie Reyes-Habito, Xinaida T Lima, Alexa B Kimball |
Journal | Journal of drugs in dermatology : JDD
(J Drugs Dermatol)
Vol. 12
Issue 6
Pg. 633-7
(Jun 01 2013)
ISSN: 1545-9616 [Print] United States |
PMID | 23839178
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Androstenes
- Contraceptives, Oral, Combined
- drospirenone and ethinyl estradiol combination
- Ethinyl Estradiol
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Topics |
- Acne Vulgaris
(drug therapy, pathology)
- Adolescent
- Adult
- Androstenes
(administration & dosage, adverse effects, therapeutic use)
- Contraceptives, Oral, Combined
(administration & dosage, adverse effects, therapeutic use)
- Double-Blind Method
- Ethinyl Estradiol
(administration & dosage, adverse effects, therapeutic use)
- Female
- Humans
- Inflammation
(drug therapy, pathology)
- Middle Aged
- Severity of Illness Index
- Torso
- Treatment Outcome
- Young Adult
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