CTRI/2022/04/042178 [Registered on: 26/04/2022] Trial Registered Prospectively
Last Modified On:
19/09/2023
Post Graduate Thesis
No
Type of Trial
BA/BE
Type of Study
Study Design
Other
Public Title of Study
Comparison of Tretinoin Cream 0.025% from Cadila Healthcare Limited with RETIN-A (Tretinoin) Cream, 0.025% (Valeant Pharmaceuticals North America LLC., USA) and placebo in the treatment of acne vulgaris
Scientific Title of Study
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) to
RETIN-A® (Tretinoin) Cream, 0.025% (Valeant Pharmaceuticals North America
LLC., USA) in Subjects with Acne Vulgaris.
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
Protocol No.: CRL121951 Version: 02 Date: 25 Oct 2021
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Dharmesh Domadia
Designation
Vice President - Global Clinical Operations
Affiliation
Cliantha Research Limited
Address
Department Clinical Trials, Room no. 01, 2nd floor, 6, Arista@Eight Corporate House, Near Satyam House, Behind Rajpath Club, Bodakdev, Ahmadabad-380054, Gujarat, India.
Ahmadabad GUJARAT 380054 India
Phone
079-66219555
Fax
07966219549
Email
ddomadia@cliantha.com
Details of Contact Person Scientific Query
Name
Dr Ankesh Barnwal
Designation
Associate Director- I– Clinical Trial Medical Services
Affiliation
Cliantha Research Limited
Address
Department Clinical Trials, 1st floor, 6, Arista@Eight Corporate House, Near Satyam House, Behind Rajpath Club, Bodakdev, Ahmadabad-380054, Gujarat, India.
Ahmadabad GUJARAT 380054 India
Phone
Fax
079-66219549
Email
abarnwal@cliantha.com
Details of Contact Person Public Query
Name
Mr Harsh Trivedi
Designation
Project Manager - Clinical Trials
Affiliation
Cliantha Research Limited
Address
Department Clinical Trials, Room
no. 01, 2nd floor, 6, Arista@Eight Corporate House,
Near Satyam House, Behind Rajpath Club,
Bodakdev, Ahmadabad-380054, Gujarat, India.
Ahmadabad GUJARAT 380054 India
Phone
Fax
079-66219549
Email
htrivedi@cliantha.com
Source of Monetary or Material Support
Cadila Healthcare Limited,Zydus Corporate Park, Scheme No. 63, Survey No. 536, Khoraj (Gandhinagar), Nr. Vaishnodevi Circle, S.G. Highway, Ahmedabad – 382 481, India.
Primary Sponsor
Name
Cadila Healthcare Limited
Address
Zydus Corporate Park, Scheme No.63, Survey No. 536, Khoraj (Gandhinagar), Nr. Vaishnodevi Circle, S.G. Highway, Ahmedabad-382481, India
Room no. 230, 2nd floor, dept. of Skin & V.D, Indira Gandhi Institution of Medical science, Patna, Bihar Patna BIHAR
7764049225
sinhaderma@gmail.com
Dr Hemant Talanikar
Jivanrekha Multispeciality Hospital
OPD No. 03, 1st Floor, Jivanrekha Multispeciality Hospital, Sr. No. 28, Prabhu Complex, Opp. To Republic School, Dehuroad, Pune-412101, Maharashtra, India Pune MAHARASHTRA
9422087726
hemant.vasant16@gmail.com
Dr P Guru Prasad
King george Hospital, Andhra Medical College,
OPD, 2nd floor, Clinical research room, Dept. of Dermatology, King george Hospital, Maharanipeta, Vishakhapatnam- 530002, Andhra pradesh Visakhapatnam ANDHRA PRADESH
Room no.2, 5th floor, Saptashrungi Hospital, Surya Avenue, Pathardi road, above State Bank of India, Dnyaneshwar nagar, Pathardi Phata, Nashik-422010 Maharashtra, India Nashik MAHARASHTRA
9224702306
drsachinyeole@gmail.com
Dr Neela Patel
Sheth L.G Muncipal General Hospital
OPD, 2nd floor, Dept. of Dermatology, Sheth L.G Muncipal General Hospital, near Rambaug, Maninagar, Ahmedabad-380008, Gujarat Ahmadabad GUJARAT
Subjects or guardian will be
instructed to apply a small
amount of IP topically once daily at bedtime for 84 consecutive days from Day 0 as per randomization schedule
Intervention
Tretinoin cream USP, 0.025%
Subjects or guardian will be
instructed to apply a small
amount of IP topically once daily at bedtime for 84 consecutive days from Day 0 as per randomization schedule
Inclusion Criteria
Age From
12.00 Year(s)
Age To
40.00 Year(s)
Gender
Both
Details
Subjects will be eligible for inclusion in this study only if all of
the following criteria apply:
1. Male or non-pregnant, non-lactating female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris.
2. 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).
3. Investigator’s Global Assessment (IGA) of acne severity grade 2, 3 OR 4.
4. 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.
5. Willing to provide written informed consent or assent (as applicable).
6. If female of childbearing potential, willing to use an acceptable form of birth control during the study.
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.
8. Subject who received COVID-19 vaccine should have recovered from vaccine related side effects prior to screening.
ExclusionCriteria
Details
Subjects will not be eligible for inclusion in this study if any of
the following criteria apply:
1. Females who are breastfeeding, pregnant or planning to become pregnant.
2. Subjects who have acne conglobata, acne fulminans, nodulocystic acne and secondary acne (e.g., chloracne and drug induced acne).
3. Subjects who have a severe or intense irritation on the face.
4. 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).
5. 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.
6. History of hypersensitivity or allergy to tretinoin, retinoids, or any of the investigational product ingredients.
7. 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).
8. 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.
9. 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.
10. 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.
11. 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.
12. Use of astringents and toners for less than 2 weeks prior to baseline.
13. 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.
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,
hydration and phenobarbital.
15. A significant medical history of or are currently immunocompromised or receiving immunomodulators/biologics since last 3 months.
16. Subjects who have been treated with an investigational product or investigational device within a period of 30 days prior to study enrollment.
17. Have any systemic or dermatologic disease that may affect the evaluation of study results.
18. Subjects who have been previously enrolled in this study.
19. Subjects who engage in activities that involve excessive or prolonged exposure to sunlight or weather extremes, such as wind or cold.
20. 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).
21. Subjects with any application site reaction assessment score 3 (severe, marked/intense).
22. Anti-pruritic, including antihistamines, within 24 hours of baseline visit.
23. Use of tanning booths or tanning lamps within one week prior to baseline and an unwillingness to refrain from use during the study.
24. Subjects with clinically significant unstable medical disorders, life-threatening disease, or current malignancies.
25. Subjects with signs and symptoms suggestive of COVID 19 infection.
26. Institutionalized subject.
27. Live in the same household as currently enrolled subjects.
28. 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
Computer generated randomization
Method of Concealment
Not Applicable
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
1. To evaluate bioequivalence (with clinical endpoint) 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. 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.
15 weeks
Secondary Outcome
Outcome
TimePoints
To assess safety and tolerability of the study treatments
Safety will be assessed for total study duration of
15 weeks
Target Sample Size
Total Sample Size="715" Sample Size from India="715" Final Enrollment numbers achieved (Total)= "715" Final Enrollment numbers achieved (India)="715"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This clinical trial intended to Evaluate the Efficacy and
Safety 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.
Objectives
Primary Objective –
1.To evaluate bioequivalence (with clinical
endpoint) of Tretinoin cream USP, 0.025
% of Cadila Healthcare Ltd. with RETIN-A® Cream,
0.025 % of Valeant Pharmaceuticals North AmericaLLC.,
USA in subjects with acne vulgaris.
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 AmericaLLC., USA over placebo in subjects
with acne vulgaris.
Secondary Objective
To assess safety and tolerability
of the study treatments