Health Condition 1: L700- Acne vulgaris
Conditions
Interventions
Intervention1: Adapalene Gel USP, 0.1%: He/ she needs to apply a thin film of either Test gel once daily to the entire face once daily in evening for 12 weeks after cleaning the face with a mild or s
Sponsors
Aurobindo Pharma
Axis Clinicals Limited
Eligibility
Inclusion criteria
Inclusion criteria: Healthy male or non-pregnant female aged between >= 12 and Subject having >= 25 non-inflammatory lesions (i.e., open and closed comedones) and >= 20 inflammatory lesions (i.e., papules and pustules) and Subject having clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per IGA scale in Appendix-3 Subject willing to refrain from use of all other topical acne medications or antibiotics during the 12 week treatment period Subject/ LAR willing to give their written informed consent (incase of subject with age >= 18 years) and written informed assent (incase of subject Female of childbearing potential, willing to use an acceptable form of birth control during the study
Exclusion criteria
Exclusion criteria: Subject having presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris (e.g., on the face: rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acne form eruptions caused by medications, steroid acne, steroid folliculitis or bacterial folliculitis) Subject having excessive facial hair (e.g. beards, sideburns, moustaches etc.) that would interfere with diagnosis or assessment of acne vulgaris Subject with history of hypersensitivity or allergy to Adapalene, retinoids and/or any of study medication ingredients or anaphylactoid/anaphylactic reactions (e.g., skin rash, pruritus, hives, chest pain, edema, and shortness of breath) Subject used oral retinoids (e.g. Accutane®) or therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed) within 6 months prior to baseline Subject used estrogens or oral contraceptives for less than 3 months prior to baseline; use of such therapy must remain constant throughout the study Subject used cryodestruction or chemodestruction, dermabrasion, photodynamic therapy, acne surgery, intralesional steroids, or x-ray therapy on face within 1 month prior to baseline or planning to use during the study Subject used systemic steroids, systemic antibiotics, systemic treatment for acne vulgaris (other than oral retinoids, which require a 6 month washout), or systemic anti-inflammatory agents within 1 month prior to baseline or planning to use during the study Subject used topical steroids, topical retinoids, topical acne treatments including over-the-counter preparations, topical anti-inflammatory agents, or topical antibiotics within 2 weeks prior to baseline or planning to use during the study Subject who is planning to use spironolactone during the study Subject who had participated in another investigational drug or device research study within 30 days of enrolment Subject who used any medication or has any disease which in the judgment of the Investigator will interfere with the conduct or interpretation of the study Female subject who is pregnant, nursing or planning a pregnancy during the study Subject who is using preparations containing sulfur, resorcinol, or salicylic acid Subject with known history of HIV, HBsAg and HCV
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects with a clinical response of success at week 12. Percentage of subjects who achieved at least 50 % reduction in lesion counts (inflammatory, non-inflammatory and total lesion count) at week 12. Timepoint: Visit 2, 3, 4 and 5 | — |
Primary
| Measure | Time frame |
|---|---|
| Mean percent change from baseline to week 12 in the inflammatory (papules and pustules) lesion count. â?¢ Mean percent change from baseline to week 12 in the non-inflammatory (open and closed comedones) lesion count.Timepoint: Visit 2, 3, 4 and 5 | — |
Countries
India
Contacts
Public ContactDr Subhra Lahiri
Axis Clinicals Ltd
Outcome results
None listed