This is a placebo-controlled trial to evaluate the clinical equivalence of Tapinarof cream 1% of Dr Reddy’s Laboratories Ltd versus VTAMA® (Tapinarof cream 1%, Dermavant Sciences Inc.) using the clinical endpoint in patients with plaque psoriasis.

Phase 3

Not yet recruiting

Conditions: Diseases of the skin and subcutaneous tissue,

Registration Number: CTRI/2025/05/086689

Lead Sponsor: Dr. Reddy’s Laboratories Ltd.

Brief Summary: Primary objective is to evaluate the efficacy of Tapinarof cream, 1% compared with Vtama Cream and Placebo (vehicle) cream in adults with plaque psoriasis and secondary objective is to evaluate the safety and tolerability of Tapinarof cream, 1% compared with Vtama Cream and Placebo (vehicle) cream in adults with plaque psoriasis.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 400

Inclusion Criteria

1. Adult Human trial participants 18 to 65 years of age (both inclusive).
1. Trial participants with Clinical diagnosis of plaque psoriasis and stable disease for at least 6 months prior to the study.
1. Trial participants with a diagnosis of plaque psoriasis as evidenced by Body surface area (BSA) involvement greater than or equal to 3 percentage and less than or equal to 20 percentage (the participants face, scalp, groin, palms, and soles should be excluded from the percent of total BSA (percentage BSA) calculations).
1. A Physicians Global Assessment (PGA) score of 2 (mild), 3 (moderate) or 4 (severe) at screening.
1. Participant must be willing to refrain from using all other topical plaque psoriasis products during the 12 week treatment period, other than the investigational product.
1. Females of childbearing potential must have a negative serum pregnancy test at the Screening.
1. Females of child-bearing potential and male trial participants who are engaging in sexual activity with females of child-bearing potential that could lead to pregnancy must use at least 1 of the following adequate birth control methods while on study and for 4 weeks after the last exposure to investigational product.
Acceptable contraception methods are: Male partner with vasectomy, OR Male condom AND partner use of 1 of the contraceptive options below: i) Spermicide ii) Contraceptive subdermal implant that meets effectiveness criteria including a less than 1 percentage rate of failure per year, as stated in the product label.
iii) Intrauterine device or intrauterine system that meets effectiveness criteria including a less than 1 percentage rate of failure per year, as stated in the product label.
iv) Oral contraceptive, either combined or progestogen alone.
v) Injectable progestogen vi) Contraceptive vaginal ring.
1. Capable of giving written informed consent, as applicable, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF); written informed consent must be obtained prior to any study related procedures.

Exclusion Criteria

1. Females who are pregnant, breast feeding, or who wish to become pregnant during the study period 2) Current diagnosis of unstable forms of psoriasis in the treatment area, including guttate, erythrodermic, exfoliative or pustular psoriasis 3) Other inflammatory skin disease in the treatment area that may confound the evaluation of the plaque psoriasis (e.g., atopic dermatitis, contact dermatitis, tinea corporis) 4) Presence of pigmentation, extensive scarring, or pigmented lesions in the treatment areas, which could interfere with the rating of efficacy parameters 5) History of hypersensitivity to any component of the test product or reference standard 6) Current immunosuppression 7) Use within one month or within 5 half-lives (whichever is longer) prior to baseline of: (i) systemic steroids, (ii) systemic antibiotics, (iii) systemic antipsoriatic treatment, (iV) psoralen plus ultraviolet A (PUVA) therapy, (v) ultraviolet B (UVB) therapy, or (vi) systemic anti-inflammatory agents 8) Use within 2 weeks prior to baseline of: (i) topical anti-psoriatic drugs (e.g., salicylic acid, anthralin, coal tar, calcipotriene, tazarotene, (ii) topical corticosteroids, (iii) immunosuppressive drugs (e.g., tacrolimus, pimecrolimus), or (iv) topical retinoids 9) Other prescription and over-the-counter drug products, procedures, and activities that are prohibited during the study, such as a) Topical product other than the assigned treatment (including moisturizers, new brands of make-up, creams, ointments, lotions, and powders) applied on or near the treatment area b) Topical or systemic antipsoriatic treatment (e.g., anthralin, coal tar, tazarotene, retinoids, tacalcitol, infliximab, adalimumab, alefacept, PUVA therapy, UVB therapy) c) Topical or systemic corticosteroids d) Immunosuppressive drugs e) Initiation of or changes to non-antipsoriatic concomitant medication that could affect psoriasis (e.g., beta blockers, lithium) during the study f) Tanning booths, sun lamps, or nonprescription UV light sources g) Phototherapy h) The treated areas should not be bandaged, covered or wrapped as to be occlusive i) Subjects should be instructed to minimize exposure to natural sunlight, to not allow the ointment to come in contact with the face or eyes and to always wash hands thoroughly after use 10) Concurrent or history of other inflammatory, infectious and immunocompromised diseases 11) Current or chronic history of liver disease, known hepatic or biliary abnormalities 12) Current or a history of cancer within 5 years 13) A history of or ongoing serious illness or medical, physical, or psychiatric condition(s) that, in the Investigator’s opinion, may interfere with the subjects’ participation in the trial and ability to understand and give informed consent.
1. Planned surgery or hospitalization (anticipated to last greater than 72 hours) during the trial.
1. Any other medical condition that, in the opinion of the Investigator, renders the participants unable to or unlikely to complete the trial or that would interfere with optimal participation in the trial or produce significant risk to the participant.
1. Clinically significant abnormalities in ECG or Screening laboratory parameters 17) Non-cooperation with clinical trial staff.

Study & Design

Study Type: BA/BE

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the efficacy of Tapinarof cream, 1% compared with Vtama Cream and Placebo (vehicle) cream in adults with plaque psoriasis	Proportion of trial participants who achieve a Physician’s Global Assessment (PGA) score of clear (0) or almost clear (1) with a minimum 2-grade improvement from Baseline to Week 12

Secondary Outcome Measures

Name	Time	Method
To evaluate the safety and tolerability of Tapinarof cream, 1% compared with Vtama Cream and Placebo (vehicle) cream in adults with plaque psoriasis	i) Mean change in percentage Body Surface Area (BSA) affected from Baseline to Week 12.

Trial Locations

Locations (26): Aartham Multi Super Speciality Hospital
🇮🇳
Ahmadabad, GUJARAT, India
All India Institute of Medical Sciences Bathinda
🇮🇳
Bathinda, PUNJAB, India
Apex Hospital Pvt. Ltd.
🇮🇳
Jaipur, RAJASTHAN, India
Asian Institute of Medical Sciences
🇮🇳
Mumbai, MAHARASHTRA, India
Department of Skin VD, Indira Gandhi Institute of medical Sciences(IGIMS)
🇮🇳
Patna, BIHAR, India
Dhiraj Hospital
🇮🇳
Vadodara, GUJARAT, India
DHS Multispeciality Hospital
🇮🇳
Ahmadabad, GUJARAT, India
Dr. B R Ambedkar Medical College
🇮🇳
Bangalore, KARNATAKA, India
Dr. Sachans Skin, Hair and Cosmetic Clinic
🇮🇳
Dehat, UTTAR PRADESH, India
Excel care Hospital
🇮🇳
Jaipur, RAJASTHAN, India
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Aartham Multi Super Speciality Hospital
🇮🇳Ahmadabad, GUJARAT, India
Dr Anshul Warman
Principal investigator
9898105539
anshulwarman@rediffmail.com