A Randomized, Double-Blind, Multicenter, Three arm, Active and Placebo-Controlled, Parallel Design Study to Evaluate the Bioequivalence (with Clinical Endpoint) of Tretinoin Cream USP, 0.10% of Encube Ethicals Pvt. Ltd., India Versus RETIN-A® (Tretinoin) Cream, 0.10% of Bausch Health US, LLC Bridgewater, NJ 08807 USA in Subjects with Acne Vulgaris
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 610
- 试验地点
- 20
- 主要终点
- 1. Mean percent change from baseline to Week 12 (Day 84) for inflammatory (papules and pustules) lesion count.
研究概览
简要总结
This clinical trial intended to Evaluate the Efficacy andSafety of Tretinoin cream USP, 0.10%) of Encube Ethicals Pvt. Ltd., India withreference product (RETIN-A® Cream, 0.10%) of Bausch Health US, LLCBridgewater, NJ 08807 USA. in Subjects with Acne Vulgaris.
Objectives:
1. To evaluate bioequivalence (with clinicalendpoint) of test product (Tretinoin Cream USP, 0.10%) of Encube Ethicals Pvt.Ltd., India with reference product (RETIN-A® Cream, 0.10%) of BauschHealth US, LLC Bridgewater, NJ 08807 USA.
2. To evaluate the superiority in efficacy oftest and reference products over the placebo.
3. To assess safety and tolerability of thestudy treatments.
Number of Subjects:
Approximately 610 subjects shall beenrolled/randomized into the study with 2:2:1 allocation ratio (i.e. Testproduct: 244 subjects, Reference product: 244 subjects and Placebo: 122 subjects).
Clinical evaluations will beperformed at the following visits:
Visit 1#: Screening visit (Up to 3Days prior to Randomization)
Visit 2#/ Day 0: Baseline /Randomization visit
Visit 3/ Week 2/ Day 14 (± 2 days):Interim Visit
Visit 4/ Week 4/ Day 28 (± 2 days):Interim Visit
Visit 5/ Week 8/ Day 56 (± 4 days):Interim Visit
Visit 6/ Week 12/ Day 84 (± 4days): End of Treatment Visit *
Visit 1 & 2 activities can beperformed on same day. Common
activities will be performed onlyonce.
*Activities to be performed in caseof early termination as per end
of treatment visit.
Safety Follow-up/ End of Study: 7days (± 2 days) after the last
application of study treatment. Itmay be performed telephonically
or subject may visit thestudy site.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 12.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •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 4 (Refer Table 8-2).
- •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 entire study duration.
- •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.
排除标准
- •Subjects will not be eligible for inclusion in this study if any of the following criteria apply:
- •Female who is breastfeeding, pregnant or planning to become pregnant.
- •Subject who has acne conglobata, acne fulminans, nodulocystic acne and secondary acne (e.g., chloracne and drug induced acne).
- •Subject who has clear symptoms of 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 (e.g., oral or injectable) antibiotics 4) Systemic treatment for acne vulgaris (other than oral retinoids which require a 6-month washout) or 5) Systemic anti-inflammatory agents or immunosuppressive drugs.
- •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 6) Astringents and toners 7) abradants, facials, peels containing glycolic or other acids 8) masks 9) washes or soaps containing benzoyl peroxide, salicylic acid, or sulfacetamide sodium 10) non-mild facial cleansers 11) moisturizers that contained retinol 12) moisturizers that contained retinol, salicylic acid or α- or β-hydroxy acids.
- •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.
- •A significant medical history of or are currently immunocompromised or receiving immunomodulators/biologics since last 3 months.
- •Subject who has 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.
- •Subject who has been previously enrolled in this study.
- •Subject 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).
- •Subject with any application site reaction assessment score 3 (severe, marked/intense).
- •(Refer to Table 8-3)
- •Use of Anti-pruritic, including antihistamines, within 24 hours of baseline visit.
- •Subject with clinically significant unstable medical disorders, life-threatening disease, or current malignancies.
- •Subject with signs and symptoms suggestive of COVID 19 infection.
- •Institutionalized subject.
- •Living in the same household of a subject who is currently participating or living in the same household of a subject who has previously participated in the study.
- •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.
结局指标
主要结局
1. Mean percent change from baseline to Week 12 (Day 84) for inflammatory (papules and pustules) lesion count.
时间窗: Mean percent change from baseline to Week 12 (Day 84)
2. Mean percent change from baseline to Week 12 (Day 84) in the non-inflammatory (open and closed comedones) lesion count.
时间窗: Mean percent change from baseline to Week 12 (Day 84)
次要结局
- Proportion of subjects with a clinical response (IGA) of “Success†at Week 12.(Note: Success will be defined as an IGA score that is at least 2 grades less than the baseline assessment. Failure will be defined as an IGA score that is the same, higher or one grade lower than the baseline assessment.)