CTRI/2022/04/042178CompletedNot Applicable
A Randomized, Double-Blind, Multicenter, Three arm, Active and Placebo-Controlled, Parallel Study to Evaluate the Bioequivalence (with Clinical Endpoint) of Tretinoin Cream USP, 0.025% (Cadila Healthcare Ltd., India) toRETIN-A® (Tretinoin) Cream, 0.025% (Valeant Pharmaceuticals North AmericaLLC., USA) in Subjects with Acne Vulgaris.
Cadila Healthcare Limited19 sites in 1 country715 target enrollmentStarted: July 23, 2022Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Cadila Healthcare Limited
- Enrollment
- 715
- Locations
- 19
- Primary Endpoint
- 1. To evaluate bioequivalence (with clinical endpoint) of Tretinoin cream USP, 0.025 % of Cadila
Study Overview
Brief Summary
This clinical trial intended to Evaluate the Efficacy andSafety of Tretinoin cream USP, 0.025 % of Cadila Healthcare Ltd. with RETIN-A®Cream, 0.025 % of Valeant Pharmaceuticals North America LLC., USA in Subjectswith Acne Vulgaris.
Objectives
Primary Objective –
1. To evaluate bioequivalence (with clinicalendpoint) of Tretinoin cream USP, 0.025% of Cadila Healthcare Ltd. with RETIN-A® Cream,0.025 % of Valeant Pharmaceuticals North America LLC.,USA in subjects with acne vulgaris.
2. Toevaluate the superiority of Tretinoin cream USP, 0.025 % of Cadila HealthcareLtd. and RETIN-A® Cream, 0.025 % of ValeantPharmaceuticals North America LLC., USA over placebo in subjectswith acne vulgaris.
Secondary Objective
To assess safety and tolerabilityof the study treatments
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 12.00 Year(s) to 40.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Subjects will be eligible for inclusion in this study only if all of the following criteria apply:
- •Male or non-pregnant, non-lactating female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris.
- •On the face, ≥ 25 non-inflammatory lesions (i.e., open and closed comedones) AND ≥ 20 inflammatory lesions (i.e., papules and pustules) AND ≤ 2 nodulocystic lesions (i.e., nodules and cysts).
- •Investigator’s Global Assessment (IGA) of acne severity grade 2, 3 OR
- •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.
- •Willing to provide written informed consent or assent (as applicable).
- •If female of childbearing potential, willing to use an acceptable form of birth control during the study.
- •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.
- •Subject who received COVID-19 vaccine should have recovered from vaccine related side effects prior to screening.
Exclusion Criteria
- •Subjects will not be eligible for inclusion in this study if any of the following criteria apply:
- •Females who are breastfeeding, pregnant or planning to become pregnant.
- •Subjects who have acne conglobata, acne fulminans, nodulocystic acne and secondary acne (e.g., chloracne and drug induced acne).
- •Subjects who have a severe or intense irritation on the face.
- •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).
- •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.
- •History of hypersensitivity or allergy to tretinoin, retinoids, or any of the investigational product ingredients.
- •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).
- •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.
- •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.
- •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.
- •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.
- •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.
- •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, hydration and phenobarbital.
- •A significant medical history of or are currently immunocompromised or receiving immunomodulators/biologics since last 3 months.
- •Subjects who have been treated with an investigational product or investigational device within a period of 30 days prior to study enrollment.
- •Have any systemic or dermatologic disease that may affect the evaluation of study results.
- •Subjects who have been previously enrolled in this study.
- •Subjects who engage in activities that involve excessive or prolonged exposure to sunlight or weather extremes, such as wind or cold.
- •Current drug abuse (including, but not limited to, cannabinoids and cocaine) or alcohol abuse (greater than two drinks per day) or relevant abuse history (within the past year).
- •Subjects with any application site reaction assessment score 3 (severe, marked/intense).
- •Anti-pruritic, including antihistamines, within 24 hours of baseline visit.
- •Use of tanning booths or tanning lamps within one week prior to baseline and an unwillingness to refrain from use during the study.
- •Subjects with signs and symptoms suggestive of COVID 19 infection.
- •Institutionalized subject.
- •Live in the same household as currently enrolled subjects.
- •Clinically significant abnormal findings or condition (other than acne vulgaris), which might, in the opinion of the Investigator, interfere with study evaluations or pose a risk to subject safety during the study.
Outcomes
Primary Outcomes
1. To evaluate bioequivalence (with clinical endpoint) of Tretinoin cream USP, 0.025 % of Cadila
Time Frame: 15 weeks
Healthcare Ltd. with RETIN-A® Cream, 0.025 % of Valeant Pharmaceuticals North America LLC., USA in subjects with acne vulgaris.
Time Frame: 15 weeks
2. To evaluate the superiority of Tretinoin cream USP, 0.025 % of Cadila Healthcare Ltd. and RETIN-A® Cream, 0.025 % of Valeant Pharmaceuticals North America LLC., USA over placebo in subjects with acne vulgaris.
Time Frame: 15 weeks
Secondary Outcomes
- To assess safety and tolerability of the study treatments(Safety will be assessed for total study duration of)
Investigators
Study Sites (19)
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