This study is conducted to know the effectiveness of Adapalene 0.1% gel on patients having mild, moderate and severe pimples and to know how such patients will tolerate the medicine and how safe it is in these patients.

Not yet recruiting

• Conditions: Acne vulgaris,

• Registration Number: CTRI/2020/11/028831
• Lead Sponsor: THINQ PharmaCRO Private Limited

Brief Summary

This study is multicentre, double-blind, randomized, three arm, active and placebo controlled, parallel study to evaluate the bioequivalence (with clinical endpoint) of Adapalene Gel, 0.1% daily where study medication will be applied to affected areas of the face once daily in the evening before retiring for 84 consecutive days in 675 acne vulgaris patients. Total study duration for the clinical study will be around 98 days that includes screening period of 14 days plus treatment period of 84 days. The study will be conducted in 10 centres in India. Primary endpoint will be mean percent change from baseline to week 12 (Day 84) in the inflammatory (papules and pustules) lesion count and mean percent change from baseline to week 12 (Day 84) in the non-inflammatory (open and closed comedones) lesion count. The secondary endpoints is proportion of subjects with a clinical response of “Success†at week 12. Safety endpoints are Treatment Emergent Adverse events(TEAE) and local tolerability assessment.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2021-08-17
• Study Start: 2021-11-01

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 675

Inclusion Criteria

• 1)Male or non-pregnant, non-lactating female aged 12 to 40 years with a clinical diagnosis of acne vulgaris with facial involvement.
• 2)Written informed consent had to be obtained and for Subjects aged 12 to 17 years, had to sign an assent for the study and a parent or a legal guardian had to sign the informed consent.
• 3)On the face, 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).
• 4)Investigator’s Global Assessment (IGA) of acne severity grade 2, 3 or 4 (refer the table below).
• ScoreDescription 0 Clear skin with no inflammatory or non-inflammatory lesions.
• 2 Mild severity; greater than Grade 1;Some non-inflammatory lesions with no more than a few inflammatory lesions (papules/pustules only, no nodular lesions) 3 Moderate Severity; greater than Grade 2; up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesion.
• 4 Severe; greater than Grade 3; up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than a few nodular lesions 5.Willing to refrain from use of all other topical acne medications or antibiotics during the 12 weeks treatment period.
• 6.Male subjects and female of childbearing potential, willing to use an acceptable form of birth control during the study period.
• 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.

Exclusion Criteria

• 1.Females who are breast feeding, pregnant or planning to become pregnant.
• 2.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).
• 3.Subjects who have acne conglobata, acne fulminans and secondary acne (e.g., chloracne and drug induced acne).
• 4.Excessive facial hair (e.g. beards, sideburns, moustaches, etc.), tattoos that would interfere with diagnosis or assessment of acne vulgaris.
• Well-trimmed moustaches are allowed.
• Subjects who have performed wax epilation of the face within 14 days prior to baseline.
• 5.History of hypersensitivity or allergy to adapalene, retinoids and/or any of the study medication ingredients.
• 6.Subjects who have a severe or intense irritation on the Face.
• 7.Use within 6 months prior to baseline (Randomization) or during the study 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 baseline (Randomization) of estrogens or oral contraceptives; use of such therapy is allowed, if it will remain constant throughout the study.
• 9.Use on the face within 1 month prior to baseline (Randomization) or during the study of: a) cryo destruction or chemo destruction, b) dermabrasion, c) photodynamic therapy, d) acne surgery, e) intralesional steroids, or f) x-ray therapy, or g) chemical or laser peel.
• 10.Use within 1 month prior to baseline (Randomization) of: a) androgen receptor blockers for acne (such as spironolactone or flutamide), b) systemic steroids (including intranasal and inhaled corticosteroids),c)systemic antibiotics, d) systemic treatment for acne vulgaris (other than oral retinoids, which require a 6-month washout), or e) systemic anti-inflammatory agents.
• 11)Use within 2 weeks prior to baseline or during the study of a) topical steroids, b) topical retinoids,c)topical acne treatments including over-the-counter preparations, d) topical anti-inflammatory agents, or e) topical antibiotics.
• l2)Use of astringents and toners for less than 2 weeks prior to the start of the study.
• 13)Use of abradants, facials, peels containing glycolic or other acids, masks; washes or soaps containing benzoyl peroxide, salicylic acid, or sulfacetamide sodium; non-mild facial cleansers; moisturizers that contained retinol, salicylic acid or alpha or beta hydroxy acids within the previous 2 weeks.
• 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)Anti-pruritic, including antihistamines, within 24 hours of baseline visits.
• 16)Use of tanning booths or tanning lamps within 1 week prior to baseline and an unwillingness to refrain from use during the study.
• 17)A significant medical history of or are currently immunocompromised or receiving immunomodulators/biologics since last 3 months.
• 18)Have any systemic or dermatologic disease that may affect the evaluation of study results.
• 19)Subjects with clinically significant unstable medical disorders, life-threatening disease, or current malignancies.
• 20)Subjects who engage in activities that involve excessive or prolonged exposure to sunlight or weather extremes, such as wind or cold.
• 21)Subjects who are institutionalized.
• 22)Current drug abuse (including, but not limited to, cannabinoids and cocaine) or alcohol abuse (greater than two drinks per day).
• 23)Subjects with any local tolerability assessment score 3 (severe, marked/intense).
• 24)Lived in the same household as currently enrolled subjects.
• 25)Subjects who have been treated with an investigational product or investigational device within a period of 30 days prior to study enrollment.
• 26)Subjects who have been previously enrolled in the study.
• 27. 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.

Study & Design

• Study Type: BA/BE
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean percent change from baseline to week 12 (Day 84) in the inflammatory (papules and pustules) lesion count.	Baseline to week 12 (Day 84)
Mean percent change from baseline to week 12 (Day 84) in the non-inflammatory (open and closed comedones) lesion count.	Baseline to week 12 (Day 84)

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects with a clinical response of “Success†at week 12.	At week 12

Trial Locations

Locations (10)

Abhinav Multispeciality Hospital; 🇮🇳 Nagpur, MAHARASHTRA, India

Ajanta Hospital and IVF Centre; 🇮🇳 Lucknow, UTTAR PRADESH, India

All Inidia Institute of Medical Sciences; 🇮🇳 Nagpur, MAHARASHTRA, India

Janta Hospital; 🇮🇳 Varanasi, UTTAR PRADESH, India

KIMS Hospital & Research Centre; 🇮🇳 Bangalore, KARNATAKA, India

Mandya Institute of Medical Sciences; 🇮🇳 Mandya, KARNATAKA, India

Om Sai Onco Surgery Multispeciality Hospital; 🇮🇳 Kolhapur, MAHARASHTRA, India

Signus Hospital; 🇮🇳 Nashik, MAHARASHTRA, India

Sudbhawana Hospital; 🇮🇳 Varanasi, UTTAR PRADESH, India

Vijay Vallabh Hospital and Medical Research Centre; 🇮🇳 Mumbai, MAHARASHTRA, India

Abhinav Multispeciality Hospital

🇮🇳Nagpur, MAHARASHTRA, India

Dr Sudhir Kumar Bhatnagar

Principal investigator

9823148978

abhinavhospitalres13@gmail.com