This Study will evaluate the therapeutic equivalence and safety of topical Tretinoin cream in comparison to marketed product Retin-A® (Tretinoin) cream in males and nonpregnant, non-lactating female subjects with acne vulgaris.

Phase 3

Not yet recruiting

• Conditions: Acne vulgaris,

• Registration Number: CTRI/2025/06/089731
• Lead Sponsor: Aurobindo Pharma Limited

Brief Summary

1.This is a double blind, randomized, parallel, three arm, placebo-controlled, multicentric study of topical Tretinoin Cream 0.025% and Retin-A Cream 0.025% in the treatment of AV.



2.A total of five visits will be scheduled to the Investigators site i.e., Screening/Randomization/Baseline Visit i.e visit 1: Day -2/Day -1 to Day 1; and three On-treatment Visits i.e visit 2, 3 and 4: Day 15, Day 29, and Day 57 and End of Treatment EOT visit i.e visit 5: Day 85. There will be a window period of plus or minus 4 days after the start of treatment for visit 2, 3, 4 and 5. An additional telephonic follow-up visit will be conducted after 7 days of EOT visit with a window period of plus or minus 2 days for assessing safety. The total duration for each subject will be a maximum of 96 Days. If the subjects have completed all the screening assessment procedures and were eligible for randomization either on Day-2 or Day -1, then the subjects can be randomized on the same day and will be instructed to start the medication application from this day or subsequent day. Day 1 will be accounted from the start of application of study medication.



3.On visit 1, subjects will be explained about the study and an Informed Consent Form will be obtained from subjects aged greater than or equal to 18 years and from parents of subjects aged less than 18 years. Informed Assent Form will be obtained from subjects aged greater than or equal to 12 years and less than 18 years in addition to ICF obtained from parents. After signing the ICF/ IAF, subjects will complete the screening procedures such as obtaining demographics, medical and medication history, evaluation of general and systemic examination, vital signs examination, urine pregnancy test females of childbearing potential, lesion count assessment, application site evaluation\* and Investigator’s Global Assessment IGA. Concomitant medication, and adverse event recording will be performed.



All eligible subjects will be randomly assigned in 2:2:1 ratio to one of the three treatment groups in double blinded manner after review of inclusion/exclusion criteria by assessing lesion count and IGA. Subjects will be dispensed with investigational product (IP) and non-medicated cleanser and sunscreen with SPF (equal or greater than 50) along with instructions on application and shall be instructed not to open the IP at the study site. Subjects will be provided with a diary to record application details of IP, adverse events, side effects, and concomitant medication details. Any additional application and missed applications shall also be noted in the subject diary. Subjects will be instructed regarding prohibited medications and procedures during the study. Subjects will be instructed to apply the IP once daily at bedtime starting from Day 1.



4.Subjects will be requested to return to site for three evaluation visits visit 2: Day 15, visit 3: Day 29 and visit 4: Day 57 with window period of plus or minus 4 days for each visit, for efficacy and safety assessments. Subjects will be dispensed with new IP on Day 29 and Day 57 and collect the IP tube dispensed at Day 1 on Day 29 and at Day 29 on Day 57, respectively. Subjects will be instructed to bring subject diary on all these visits for evaluation of treatment compliance.



5.Application site reactions erythema, dryness, burning/stinging, erosion, edema, pain, and itching will be evaluated using 4-point scale will be assessed at each post study treatment application visit.



6.Subjects will be instructed to return to the study site on Day 85 plus or minus 4 for final assessments. General and Systemic examination, vital signs recording, urine pregnancy test for females of childbearing potential, concomitant medication, and adverse event recording will be performed. Efficacy evaluation will be done by assessing lesion count and application site reaction assessments will also be evaluated. Subjects will be requested to return the issued IP and subject diaries for compliance checking.



7.Subjects will be followed up telephonically 7 days plus or minus 2 days End of study/ Safety follow-up visit after the end of the treatment visit.



If it is necessary to see a subject other than a scheduled visit date, the unscheduled visit procedures shall be followed. If the Investigator decides to discontinue a subject at any time during the study, a standard care of treatment shall be advised at the investigator’s discretion and an early termination visit shall be performed for this purpose.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2025-06-23
• Study Start: 2025-10-07

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 980

Inclusion Criteria

• 1 Healthy male or non-pregnant and non-lactating female aged between Greater than or equal to 12 and less than or equal to 40 years with a clinical diagnosis of acne vulgaris.
• 2.Subject having 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 at baseline on the face.
• 3.Subject having clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per IGA scale in Appendix-3.
• 4.Subject must be willing to refrain from use of all other topical products moisturizer, new brands of make-up, creams, lotions, powders or any other treatment period other than the investigational products.
• 5.Subjects and LAR applicable for adolescents’ subjects willing to give their written informed consent in case of subject with age greater than or equal to 18 years and written informed assent in case of subject greater than or equal to 12 years and less than 18 years to participate in the study.
• 6.Female of childbearing potential, willing to use an acceptable form of birth control during the study.
• •Tubal sterilization tubal ligation performed more than one month before Study Day 1 transcervical tubal occlusion procedure performed more than six months before Study Day 1 •Intrauterine Device IUD •Two barrier methods used together cervical cap, diaphragm contraceptive sponge, or vaginal spermicide plus a male or female condom •Absolute sexual abstinence no sexual intercourse or genital contact with a male partner during the study conduct 7.Male subject must agree to use accepted methods of birth control with their partners, from the day of the first dose administration to 07 days after the last administration of IP.
• 8.Subject who uses make-up must have used the same brands/types of make-up for a minimum period of 14 days prior to study entry and must agree to not change make-up brand/type or frequency of use throughout the study.

Exclusion Criteria

• 1.Subject having 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.
• 2.Subject having excessive facial hair e.g. beards, sideburns, moustaches etc.
• that would interfere with diagnosis or assessment of acne vulgaris 3.
• Subject with history of hypersensitivity or allergy to Tretinoin, retinoids and/or any of study medication ingredients.
• 4.Subject with a significant medical history of or are currently immunocompromised or receiving immunomodulators/ biologics since last 3 months.
• 5.Subject used oral retinoids e.g. Accutane or therapeutic vitamin A supplements of greater than 10,000 units/day multivitamins are allowed within 6 months prior to baseline.
• 6.Subject used estrogens or oral contraceptives or any other hormonal therapy for less than 3 months prior to baseline; use of such therapy must remain constant throughout the study.
• 7.Subject used cryodestruction or chemodestruction, dermabrasion, photodynamic therapy, acne surgery, any facial surgery, intralesional steroids, or x-ray therapy on face within 1 month prior to baseline or planning to use during the study.
• Subject used spironolactone, systemic steroids, systemic antibiotics, systemic treatment for acne vulgaris other than oral retinoids, which require a 6-month washout, or systemic anti-inflammatory agents within 1 month prior to baseline or planning to use during the study.
• Subject used topical steroids, topical retinoids, topical acne treatments including over-the-counter preparations, topical anti-inflammatory agents, or topical antibiotics within 2 weeks prior to baseline or planning to use during the study.
• 10.Subject who engages in activities that involve excessive or prolonged exposure to sunlight or weather extremes, such as wind or cold.
• 11.Subject who is using preparations containing sulfur, resorcinol, or salicylic acid.
• 12.Subjects who could not be able to read and write.
• 13.Subject who had participated in another investigational drug or device research study within 90 days of enrolment.
• 14.Subject who used any medication or has any disease which in the judgment of the Investigator will interfere with the conduct or interpretation of the study.
• 15.Female subject who is pregnant, nursing or planning a pregnancy during the study.
• 16.Subject with known history of HIV, HBsAg and HCV.

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.	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.	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	Proportion of subjects with a clinical response of success at week 12

Trial Locations

Locations (24)

Anand surgical hospital pvt. Ltd.; 🇮🇳 Ahmadabad, GUJARAT, India

Assam Medical College and Hospital; 🇮🇳 Dibrugarh, ASSAM, India

Calcutta School of Tropical Medicine; 🇮🇳 Kolkata, WEST BENGAL, India

Care Multispeciality Hospital; 🇮🇳 Pune, MAHARASHTRA, India

D.Y. Patil Medical college Hospital and research center; 🇮🇳 Mumbai, MAHARASHTRA, India

Darakh Nursing Home & Kidney Stone Centre; 🇮🇳 Aurangabad, MAHARASHTRA, India

Divine Multispeciality Hospital; 🇮🇳 Gandhinagar, GUJARAT, India

Global Hospital; 🇮🇳 Surat, GUJARAT, India

Health 1 super speciality hospital; 🇮🇳 Ahmadabad, GUJARAT, India

Health point hospital; 🇮🇳 Kolkata, WEST BENGAL, India

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Anand surgical hospital pvt. Ltd.

🇮🇳Ahmadabad, GUJARAT, India

Dr Khushbu Prajapati

Principal investigator

8866770916

drkhushbuprajapati.research@gmail.com