Health Condition 1: L700- Acne vulgaris
Conditions
Interventions
Intervention1: Tretinoin cream USP, 0.1%: Subjects or guardian will be
instructed to apply a small
amount of IP topically once daily at bedtime for 84 consecutive days from Day 0 as per randomization
Sponsors
Cadila Healthcare Limited
Eligibility
Inclusion criteria
Inclusion criteria: Subjects will be eligible for inclusion in this study only if all of the following criteria apply: 1. Male or non-pregnant, non-lactating female aged >= 12 and 2. On the face, >= 25 non-inflammatory lesions (i.e., open and closed comedones) AND >= 20 inflammatory lesions (i.e., papules and pustules) AND 3. Investigatorâ??s Global Assessment (IGA) of acne severity grade 2, 3 OR 4. 4. Willing and able to refrain from use of all other topical products, all acne medications and all antibiotics (other than study treatment) during the 12-week treatment period. 5. Willing to provide written informed consent or assent (as applicable). 6. If female of childbearing potential, willing to use an acceptable form of birth control during the study. 7. Have used the same brand of make-up for a minimum period of 2 weeks prior to randomization, for subjects who use make-up and agree to not change make-up brands or types during the study. 8. Subject who received COVID-19 vaccine should have recovered from vaccine related side effects prior to screening.
Exclusion criteria
Exclusion criteria: Subjects will not be eligible for inclusion in this study if any of the following criteria apply: 1. Females who are breastfeeding, pregnant or planning to become pregnant. 2. Subjects who have acne conglobata, acne fulminans, nodulocystic acne and secondary acne (e.g., chloracne and drug induced acne). 3. Subjects who have a severe or intense irritation on the face. 4. 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. 5. Excessive facial hair (e.g., beards, sideburns, moustaches, etc.) that would interfere with the diagnosis or assessment of acne vulgaris. Well-trimmed moustaches are allowed. 6. History of hypersensitivity or allergy to tretinoin, retinoids, or any of the investigational product ingredients. 7. Use within 6 months prior to the baseline of oral retinoids (e.g., Accutane®) or therapeutic Vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed). 8. Use for less than 3 months prior to the baseline of estrogens or oral contraceptives; use of such therapy must remain constant throughout the study. 9. Use on the face within 1 month prior to baseline of 1) Cryodestruction or Chemodestruction, 2) Dermabrasion, 3) Photodynamic therapy, 4) Acne surgery, 5) Intralesional steroids, or 6) X-ray therapy. 10. Use within 1 month prior to baseline of 1) Spironolactone 2) Systemic steroids 3) Systemic antibiotics 4) Systemic treatment for acne vulgaris (other than oral retinoids which require a 6-month washout) or 5) Systemic anti-inflammatory agents. 11. Use within 2 weeks prior to baseline of 1) Topical steroids, 2) Topical retinoid 3) Topical acne treatments including over-the-counter preparations 4) Topical anti-inflammatory agents, or 5) Topical antibiotics. 12. Use of astringents and toners for less than 2 weeks prior to baseline. 13. Use of abradants, facials, peels containing glycolic or other acids, masks; washes or soaps containing benzoyl peroxide, salicylic acid, or sulfacetamide sodium; nonmild facial cleansers; moisturizers that contained retinol, salicylic acid or α- or β-hydroxy acids within the previous 2 weeks prior to baseline. 14. Concomitant use/planned to use of mega-doses of certain vitamins (such as vitamin D [ > 2000 IU/day], vitamin B6 [ > 2 mg/day] and vitamin B12 [ > 1 mg/day]), haloperidol, halogens such as iodide and bromide, lithium, hydantoin and phenobarbital. 15. A significant medical history of or are currently immunocompromised or receiving immunomodulators/biologics since last 3 months. 16. Subjects who have been treated with an investigational product or investigational device within a period of 30 days prior to study enrollment. 17. Have any systemic or dermatologic disease that may affect the evaluation of study results. 18. Subjects who have been previously enrolled in this study. 19. Subjects who engage in activities that involve excessive or prolonged exposure to sunlight or weather extremes, such as wind or cold. 20. Cu
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.To evaluate bioequivalence (with clinical endpoint) of test product (Tretinoin cream USP, 0.1 %) of Cadila Healthcare Ltd., India with reference product (RETIN-A® Cream, 0.1 %) of Valeant Pharmaceuticals North America LLC., USA 2.To evaluate the superiority of Tretinoin cream USP, 0.1 % of Cadila Healthcare Ltd. and RETIN-A® Cream, 0.1 % of Valeant Pharmaceuticals North America LLC., USA over placebo in subjects with acne vulgaris. Timepoint: 15 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess safety and tolerability of the study treatmentsTimepoint: Safety will be assessed for total study duration of 15 weeks. | — |
Countries
India
Contacts
Public ContactMr Harsh Trivedi
Cliantha Research Limited
Outcome results
None listed