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.
Scientific Title of Study
A Multicenter, Double-Blind, Randomized, Three arm, Active and Placebo Controlled, Parallel Study to Evaluate the Bioequivalence (with clinical endpoint) of Adapalene Gel, 0.1% of THINQ Pharma-CRO Private Limited, 111 North bridge road, #16-04, Peninsula plaza, Singapore-179098 to DIFFERIN® (Adapalene Gel, 0.1%) of Galderma Laboratories LP Fort Worth, Texas 76177 USA in subjects with Acne Vulgaris.
Trial Acronym
-
Secondary IDs if Any
Secondary ID
Identifier
iVRS-CD-20-006 Version: 01 Date 17 Apr 2020
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Invitro Research Solutions Pvt. Ltd, Clinical Development Department, Medical Monitoring Divison, Room No 301, 3rd Floor No. 22 & 23, Kodigehalli Main Road, Sahakar Nagar Post, Hebbal.
Bangalore KARNATAKA 560092 India
Phone
9449236330
Fax
-
Email
channa@ivrs.org.in
Details of Contact Person Public Query
Name
Mr T Vijay Bhaskar
Designation
Director-Clinical Development
Affiliation
Invitro Research Solutions Pvt. Ltd
Address
Invitro Research Solutions Pvt. Ltd, Clinical Development Department, Clinical Operations Divison, Room No 302,3rd Floor No. 22 & 23, Kodigehalli Main Road,
Sahakar Nagar Post, Hebbal.
Instituitional Ethics Committe Ajanta Hospital & IVF Centre
Approved
Instituitional Ethics Committee
Submittted/Under Review
Instituitional Ethics Committee
Submittted/Under Review
Institutional Ethics Committee
Approved
Janta Hospital Ethics Committee
Approved
KIMS Institutional Ethics Committee
Approved
Muktai Hospital Institutional Ethics Committee
Submittted/Under Review
Om Sai Onco Institutional Ethics Committee
Approved
Sudbhawana Hospital Ethics Committee
Approved
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: L700||Acne vulgaris,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
Adapalene Gel, 0.1%
A pea size amount of adapalene gel 0.1%(Comparator agent) should be applied on the affected area of the face(e.g., forehead,chin,each cheek) as required.
Avoid contact with the eyes, lips, angles of the nose, and mucous membranes.
Intervention
Test product (T): Adapalene Gel, 0.1% of THINQ Pharma-CRO Private Limited (manufactured by Unique Pharmaceutical Laboratories - A Division of J B Chemicals and Pharmaceuticals limited).
Reference product (R): DIFFERIN® (Adapalene Gel, 0.1%) of Galderma Laboratories LP.
A pea size amount of adapalene gel 0.1% THINQ Pharma-CRO Private Limited (manufactured by Unique Pharmaceutical Laboratories - A Division of J B Chemicals and Pharmaceuticals limited)
should be applied on the affected area of the face(e.g., forehead,chin,each cheek) as required.
Avoid contact with the eyes, lips, angles of the nose, and mucous membranes.
Inclusion Criteria
Age From
12.00 Year(s)
Age To
40.00 Year(s)
Gender
Both
Details
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).
Score Description
0 Clear skin with no inflammatory or non-inflammatory lesions.
1 Almost clear; rare non-inflammatory lesions with no more than one small inflammatory lesion.
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.
ExclusionCriteria
Details
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.
Method of Generating Random Sequence
Other
Method of Concealment
Centralized
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
Mean percent change from baseline to week 12 (Day 84) in the inflammatory (papules and pustules) lesion count.
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
Outcome
TimePoints
Proportion of subjects with a clinical response of “Success†at week 12.
At week 12
Target Sample Size
Total Sample Size="675" Sample Size from India="675" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
N/A
Date of First Enrollment (India)
11/01/2021
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="0" Months="5" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
NIL
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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.