CompletedPhase 3

Bioequivalence Study of Two Treatments in the Treatment of Acne Vulgaris on the Face

United States825 participantsStarted 2017-12-13

Plain-language summary

To compare the safety and efficacy of Perrigo's product to an FDA approved product for the treatment of Acne Vulgaris

Age range12 Years – 40 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Signed IRB approved written informed consent/assent
✓. 12 to 40 years of age, inclusive.
✓. Clinical diagnosis of facial acne vulgaris with an inflammatory lesion (papules and pustules) count of 20-50, inclusive and a non-inflammatory (open and closed comedones) lesion count of 25-100 inclusive and no more than 2 nodulocystic lesions (e.g., nodules and cysts) including those present on the nose.
✓. Baseline Investigator's Global Assessment Score of 3 (moderate) or 4 (severe) on a severity scale of 0 to 4.
✓. Females of child bearing potential (excluding women who are surgically sterilized (tubal ligation or bilateral oophorectomy or hysterectomy) or post-menopausal for at least 2 years), in addition to having a negative urine pregnancy test at Visit 1/Day1(Baseline), must be willing to use an acceptable form of birth control during the study.

✕. Pregnant, breastfeeding or planning a pregnancy within the period of their study participation period.
✕. Presence of more than 2 facial Nodulocystic lesions.
✕. Presence of any other facial skin condition that, in the Investigator's opinion, might interfere with acne vulgaris diagnosis and/or evaluations
✕. Any uncontrolled, chronic or serious disease or medical condition that would prevent participation in a clinical trial, or, in judgment of the investigator, would put the subject at undue risk or might confound the study assessments
✕. Excessive facial hair that would interfere with the diagnosis or assessment of acne vulgaris.
✕. History of unresponsiveness to topical adapalene and/or benzoyl peroxide therapy.
✕. Currently using any product containing adapalene and/or benzoyl peroxide and/or belonging to the same family.
✕. History of hypersensitivity or allergy to adapalene, benzoyl peroxide, retinoids and/or any ingredient in the study medication.

Mean Percent Change From Baseline in the Papules and Pustules Lesion Count

Timeframe: Day 1 to week 12

Mean Percent Change From Baseline in the Open and Closed Comedones Lesion Count

Timeframe: Day 1 to week 12

NCT IDNCT03393494

SponsorPadagis LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-09-30

Results submitted2020-11-13

Who can participate

Age range12 Years – 40 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Signed IRB approved written informed consent/assent
✓. 12 to 40 years of age, inclusive.
✓. Clinical diagnosis of facial acne vulgaris with an inflammatory lesion (papules and pustules) count of 20-50, inclusive and a non-inflammatory (open and closed comedones) lesion count of 25-100 inclusive and no more than 2 nodulocystic lesions (e.g., nodules and cysts) including those present on the nose.
✓. Baseline Investigator's Global Assessment Score of 3 (moderate) or 4 (severe) on a severity scale of 0 to 4.
✓. Females of child bearing potential (excluding women who are surgically sterilized (tubal ligation or bilateral oophorectomy or hysterectomy) or post-menopausal for at least 2 years), in addition to having a negative urine pregnancy test at Visit 1/Day1(Baseline), must be willing to use an acceptable form of birth control during the study.

✕. Pregnant, breastfeeding or planning a pregnancy within the period of their study participation period.
✕. Presence of more than 2 facial Nodulocystic lesions.
✕. Presence of any other facial skin condition that, in the Investigator's opinion, might interfere with acne vulgaris diagnosis and/or evaluations
✕. Any uncontrolled, chronic or serious disease or medical condition that would prevent participation in a clinical trial, or, in judgment of the investigator, would put the subject at undue risk or might confound the study assessments
✕. Excessive facial hair that would interfere with the diagnosis or assessment of acne vulgaris.
✕. History of unresponsiveness to topical adapalene and/or benzoyl peroxide therapy.
✕. Currently using any product containing adapalene and/or benzoyl peroxide and/or belonging to the same family.
✕. History of hypersensitivity or allergy to adapalene, benzoyl peroxide, retinoids and/or any ingredient in the study medication.