Health Condition 1: L700- Acne vulgaris
Conditions
Interventions
Intervention1: Tretinoin cream 0.025 Percent: Dose: half inch or less of medication onto a fingertip (approximately 0.5 to 1 gram)
Route of administration: Topical use only
Frequency: Once daily at b
Sponsors
Aurobindo Pharma Limited
AXIS Clinicals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1 Healthy male or non-pregnant and non-lactating female aged between Greater than or equal to 12 and less than or equal to 40 years with a clinical diagnosis of acne vulgaris. 2.Subject having greater than or equal to 25 non-inflammatory lesions i.e., open and closed comedones and greater than or equal to 20 inflammatory lesions i.e., papules and pustules and less than or equal to 2 nodulocystic lesions i.e., nodules and cysts at baseline on the face. 3.Subject having clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per IGA scale in Appendix-3. 4.Subject must be willing to refrain from use of all other topical products moisturizer, new brands of make-up, creams, lotions, powders or any other treatment period other than the investigational products. 5.Subjects and LAR applicable for adolescents subjects willing to give their written informed consent in case of subject with age greater than or equal to 18 years and written informed assent in case of subject greater than or equal to 12 years and less than 18 years to participate in the study. 6.Female of childbearing potential, willing to use an acceptable form of birth control during the study. Tubal sterilization tubal ligation performed more than one month before Study Day 1 transcervical tubal occlusion procedure performed more than six months before Study Day 1 Intrauterine Device IUD Two barrier methods used together cervical cap, diaphragm contraceptive sponge, or vaginal spermicide plus a male or female condom Absolute sexual abstinence no sexual intercourse or genital contact with a male partner during the study conduct 7.Male subject must agree to use accepted methods of birth control with their partners, from the day of the first dose administration to 07 days after the last administration of IP. 8.Subject who uses make-up must have used the same brands/types of make-up for a minimum period of 14 days prior to study entry and must agree to not change make-up brand/type or frequency of use throughout the study
Exclusion criteria
Exclusion criteria: 1.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. 2.Subject having excessive facial hair e.g. beards, sideburns, moustaches etc. that would interfere with diagnosis or assessment of acne vulgaris 3. Subject with history of hypersensitivity or allergy to Tretinoin, retinoids and/or any of study medication ingredients. 4.Subject with a significant medical history of or are currently immunocompromised or receiving immunomodulators/ biologics since last 3 months. 5.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. 6.Subject used estrogens or oral contraceptives or any other hormonal therapy for less than 3 months prior to baseline; use of such therapy must remain constant throughout the study. 7.Subject used cryodestruction or chemodestruction, dermabrasion, photodynamic therapy, acne surgery, any facial surgery, intralesional steroids, or x-ray therapy on face within 1 month prior to baseline or planning to use during the study. 8. Subject used spironolactone, 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. 9. 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. 10.Subject who engages in activities that involve excessive or prolonged exposure to sunlight or weather extremes, such as wind or cold. 11.Subject who is using preparations containing sulfur, resorcinol, or salicylic acid. 12.Subjects who could not be able to read and write. 13.Subject who had participated in another investigational drug or device research study within 90 days of enrolment. 14.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. 15.Female subject who is pregnant, nursing or planning a pregnancy during the study. 16.Subject with known history of HIV, HBsAg and HCV.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean percent change from baseline to week 12 in the inflammatory papules and pustules lesion count. Mean percent change from baseline to week 12 in the non-inflammatory open and closed comedones lesion count. Timepoint: Week 4, Week 8 and Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects with a clinical response of success at week 12Timepoint: Proportion of subjects with a clinical response of success at week 12 | — |
Countries
India
Contacts
Public ContactDr Subhra Lahiri
AXIS Clinicals Ltd
Outcome results
None listed