Perimenstrual Acne With Clindamycin Phosphate and Benzoyl Peroxide
Status:
Completed
Trial end date:
2018-07-19
Target enrollment:
Participant gender:
Summary
The study team plans to enroll a total of 40 subjects with self-reported perimenstrual acne.
Eligible women will be over the age of 18 and not on any current therapy. The patients will
first arrive for a screening visit, where they will be given questionnaires on acne quality
of life (acne QOL) and subjective assessments as well as flare ups (as used in the study by
Geller et al). The patients' skin will be assessed for inflammatory and non-inflammatory acne
vulgaris. The baseline visit (day 1) will be scheduled for one week prior to the first day of
menses (as studies indicate that most women have their acne flare during this time). The
study team will perform a zit count (counting papules, pustules, and comedones) and global
assessment, and the patient will be instructed to record their menses (which they will do for
the duration of the study). The patients will then return in 2 weeks, at day 15, and they
will be re-assessed. The patients will be dispensed the investigational product and
instructed on its daily use. The patients will continue to return every 14 days to have their
skin assessed until their final visit on day 99, one week after their 3rd menses on treatment
(4th menses on study). The duration of the study per patient is approximately 4 months, and
the study team anticipates an enrollment period of 12 months.
Phase:
Phase 2
Details
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborators:
Bausch Health Americas, Inc. Valeant Pharmaceuticals International, Inc.
Treatments:
Benzoyl Peroxide C 1027 Clindamycin Clindamycin palmitate Clindamycin phosphate