Randomized, double-blind, placebo-controlled, three-arm parallel design, multiple-site bioequivalence study with clinical endpoints

Phase 1

Completed

• Conditions: Acne vulgaris,

• Registration Number: CTRI/2020/07/026391
• Lead Sponsor: Encube Ethicals Private Limited

Brief Summary

| |

| --- |

|A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Three-arm, Parallel Study to Evaluate the Bioequivalence using Clinical Endpoint of Tretinoin Gel microsphere, 0.08% in the Treatment of 981 Subjects with Subjects with Acne Vulgaris. At screening/baseline visit, subjects shall be randomly (Double’blind) assigned in 1:1:1 fashion to one of the 3 treatment groups at visit 2.  Statistical comparisons shall be made between test and reference, test and placebo, and reference and placebo. The primary endpoint is test/reference ratio of the mean percent change from baseline to week 12 in the inflammatory (papules and pustules) and non- inflammatory (Comedones) lesion count at Visit 6. The secondary endpoint is the proportion of subjects who are considered a Clinical Success at Week 12. Safety shall be evaluated from reported adverse events and application site reaction assessments.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-25
• Last Update Posted: 2021-09-25

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 981

Inclusion Criteria

• Healthy male or non-pregnant, non- lactating female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of Acne vulgaris (AV).
• On the face, having ≥ 20 inflammatory (i.e., papules and pustules), ≥ 25 non-inflammatory (i.e., open and closed comedones) lesions and ≤ 2 nodulocystic lesions (i.e, nodules and cysts).
• 3.Investigator’s Global Assessment (IGA) of acne severity grade 2, 3 or 4.
• 4.Willing to refrain from use of all other topical products (moisturizer, new brands of make-up, creams, lotions, powders or any other topical product), all acne medications and antibiotics during the 12 weeks treatment period.
• 5.Female subjects of child bearing potential practicing an approved method of contraception and willing to continue its use from study entry to 7 days after the administration of study drug and have a negative Urine Pregnancy Test at the time of screening or Female subjects of non-child bearing potential.
• Note: Approved methods of contraception include Hormonal contraception including oral, systemic injectable or Intra-uterine Contraceptive Devices must have been on a stable dose for 3 months prior to study entry, bilateral tubal ligation or tubectomy, non-hormonal IUCD, double barrier or strict abstinence.
• Use of oral contraceptive therapy is allowed if it shall remain constant throughout the study.
• Non-child bearing potential is defined as pre-menarche, postmenopausal absence of menstrual bleeding for 1 year prior to enrolment, hysterectomy or bilateral oophorectomy.
• Male subjects must use accepted methods of birth control or must agree to practice abstinence from study entry to 7 days after the administration of study drug.
• Willing to provide written informed consent or assent, as applicable.
• For subjects who are considered minors (< 18 completed years), the parent or legal guardian shall sign the consent form and the child shall be required to sign a subject “assent†form, as appropriate.

Exclusion Criteria

• 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, acneform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis).
• Excessive facial hair (e.g. beards, sideburns, moustaches, etc.) that shall interfere with diagnosis or assessment of acne vulgaris.
• Well-trimmed moustaches are allowed.
• History of hypersensitivity or allergy to tretinoin, retinoids and/or any of the study medication ingredients.
• Use within 6 months prior to baseline (Randomisation) 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 baseline (Randomisation) of estrogens or oral contraceptives or any other hormonal therapy; use of such therapy is allowed if it shall remain constant throughout the study.
• Use on the face within 1 month prior to baseline (Randomisation) cryo-destruction or chemo-destruction, dermabrasion / microdermabrasion, photodynamic therapy, acne surgery, intralesional steroids, X-ray therapy, chemical or laser peel.
• Use within 1 month prior to baseline (Randomisation) of androgen receptor blockers for acne (spironolactone, Flutamide etc.,), systemic steroids (Including intra-nasal and in-haled corticosteroids), systemic antibiotics, systemic treatment for acne vulgaris (other than oral retinoids, which require a 6-month washout) or systemic anti-inflammatory agents.
• Use within 2 weeks prior to baseline (Randomisation) of topical steroids, topical retinoids and topical acne treatments including over-the-counter preparations, topical anti-inflammatory agents, medicated cleansers/shampoo or topical antibiotics.
• Use within 2 weeks prior to baseline (Randomisation) of abradants, facials, peels containing glycolic or other acids, masks, washes or soaps, containing glycolic acid, salicylic acid, Alpha- or beta-hydroxy acids or other acids, benzoyl peroxide (BPO) or sulfacetamide sodium, non-mild facial cleansers, moisturizers that contained retinol.
• Subjects who have undergone a facial procedure (e.g., laser peel, microdermabrasion or blue light treatment, etc.) within the past 4 weeks or if it is planned to be performed during the conduct of the study.
• Concomitant use/planned to use of mega-doses of certain vitamins (such as mega-doses of vitamin D [> 2000 IU/day], vitamin B6 [> 2 mg] or vitamin B12 [> 1 mg/day]), haloperidol, halogens such as iodide and bromide, lithium, hydantoin and phenobarbital.
• Use of tanning booths or tanning lamps or ultraviolet light within 1 week prior to Baseline and an unwillingness to refrain from use during the study.
• Subjects with planned unprotected and intense UV exposure during the study (mountain sports, UV radiation, sunbathing, etc.).
• A significant medical history of or are currently immunocompromised or receiving immunomodulators/ biologics since last 3 months.
• Subjects with clinically significant vital sign abnormality.
• Subjects with clinically significant unstable medical disorders, life-threatening disease, or current malignancies.
• Subjects who engage in activities that involve excessive or prolonged exposure to sunlight or weather extremes, such as wind or cold.
• History of drug or alcohol abuse within last 6 months.
• Lived in the same household as currently enrolled subjects.
• Female subjects who are breast-feeding or planning to become pregnant.
• Subjects who have been treated with an investigational drug or investigational device within a period of 30 days prior to study enrolment.
• Subjects with clinically significant abnormal laboratory value which may affect the participation of the subject in the study.
• Subjects with a clinically significant disease(s) or disorder(s) other than facial acne vulgaris that in the opinion of the Investigator may (i) put the subject at risk because of participation in the study (ii) interfere with the study evaluations or (iii) cause concern regarding subject’s ability to participate in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean percent change from baseline to week 12 in the inflammatory (papules and pustules) lesion count	Day 1, Week 2, Week 4, Week 8 and Week 12
Mean percent change from baseline to week 12 in the Non-inflammatory (open and closed comedones) lesion count.	Day 1, Week 2, Week 4, Week 8 and Week 12

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects with a clinical response of “success†at week 12. (IGA score)	Day 1, Week 2, Week 4, Week 8 and Week 12
The incidence of treatment-emergent adverse events	Day 1, Week 2, Week 4, Week 8 and Week 12
Application site reaction assessments	Week 2, Week 4, Week 8 and Week 12

Trial Locations

Locations (30)

MMF Joshi Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Anand Multispecialty Hospital and Research Centre; 🇮🇳 Gandhinagar, GUJARAT, India

Asian Institute of Medical Sciences (AIMS); 🇮🇳 Thane, MAHARASHTRA, India

Bodyline Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

Dhadiwal Hospital in coaliation with Shreeji Healthcare; 🇮🇳 Nashik, MAHARASHTRA, India

DR D Y Patil Hospital and Research centre; 🇮🇳 Mumbai, MAHARASHTRA, India

GCS Medical College, Hospital and Research Centre; 🇮🇳 Ahmadabad, GUJARAT, India

Ishwar Institute of Health care; 🇮🇳 Aurangabad, MAHARASHTRA, India

Kanoria Hospital and Research Centre; 🇮🇳 Gandhinagar, GUJARAT, India

Kempegowda Institute of Medical Sciences; 🇮🇳 Bangalore, KARNATAKA, India

Scroll for more (20 remaining)

MMF Joshi Hospital

🇮🇳Pune, MAHARASHTRA, India

Dr Deshpande Ajay Jaywant

Principal investigator

08793226922

deshpandeajay.68@gmail.com