Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Balmoral Medical company
Age
12–40
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or non-pregnant, non-lactating female, ≥12 and ≤40 years of age with a clinical diagnosis of acne vulgaris.
Must have ≥ 25 but ≤ 100 non-inflammatory lesions (open and closed comedones) AND ≥ 20 but ≤ 70 inflammatory lesions (papules and pustules) AND ≤ 2 nodulocystic lesions (nodules and cysts) on the face (e.g., forehead, nose, cheeks, chin, upper lip) at Baseline.
Must be willing and able to refrain from use of all other topical products in the treatment area, all acne medications other than test article, and all antibiotics (other than test article) during the 12-week treatment period.
Women must be surgically sterile, or use an effective method of birth control with a negative urine pregnancy test (UPT) at the Baseline Visit (Day 1).
In good general health and free of any other clinically significant disease state or physical condition.
Subject has provided written informed consent / assent.
You may not be if
Subject is pregnant, breastfeeding, or is planning to become pregnant or breastfeed during the study.
Subject has more than 2 facial nodular lesions; any nodules present will be documented but not included in the inflammatory lesion count for analysis.
Subject has excessive facial hair (e.g., beards, sideburns, moustaches), facial tattoos, or other facial attributes that would interfere with diagnosis or assessment of acne vulgaris in the opinion of the investigator.
Subject is planning surgery during the study.
Subject has a history of hypersensitivity or allergy to clindamycin or lincomycin and/or any of the ingredients in the test articles.
Other Eligibility Criteria not listed above will be reviewed for each prospective subject by the study staff.
Clareo Health | Bioequivalence Study of Clindamycin Phosphate Topical Lotion, 1% in Subjects With Acne Vulgaris
