CTRI/2025/07/091443 [Registered on: 22/07/2025] Trial Registered Prospectively
Last Modified On:
26/02/2026
Post Graduate Thesis
No
Type of Trial
BA/BE
Type of Study
Study Design
Other
Public Title of Study
Clinical endpoint trial to evaluate the bioequivalence of Tapinarof cream 1%
Scientific Title of Study
A Randomized, Multicenter, Double-blind, Three-arm, Placebo-controlled, Parallel Design Study to Evaluate the Bioequivalence (with Clinical Endpoint) of Tapinarof Cream 1 Percent of Encube Ethicals Private Limited, India with VTAMA® (tapinarof) cream 1 Percent of Dermavant Sciences, Inc. in Participants with Plaque Psoriasis.
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
Protocol No.: C2A05625 Version: 01 Date: 01 May 2025
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
Cliantha Research Limited, Cliantha Corporate, TP 86, FP 28/1, Off S.P. Ring Road, Sarkhej, Ahmedabad - 382210, Gujarat, India
Ahmadabad GUJARAT 382210 India
Phone
2717698500
Fax
Email
ddomadia@cliantha.com
Details of Contact Person Scientific Query
Name
Dr Ankesh Barnwal
Designation
Director – Clinical Trials
Affiliation
Cliantha Research Limited
Address
Cliantha Research Limited, Cliantha Corporate, TP 86, FP 28/1, Off S.P. Ring Road, Sarkhej, Ahmedabad - 382210, Gujarat, India
Ahmadabad GUJARAT 382210 India
Phone
07966219500
Fax
Email
abarnwal@cliantha.com
Details of Contact Person Public Query
Name
Mr Devesh Verma
Designation
Director - Clinical Trials
Affiliation
Cliantha Research Limited
Address
Cliantha Research Limited, Cliantha Corporate, TP 86, FP 28/1, Off S.P. Ring Road, Sarkhej, Ahmedabad - 382210, Gujarat, India
Ahmadabad GUJARAT 382210 India
Phone
9712908404
Fax
Email
dverma@cliantha.com
Source of Monetary or Material Support
Encube Ethicals Private Limited, Encube Advance Research Center, Palava Phase-II, Hedutane Kalyan - 421204, Maharashtra, India
Primary Sponsor
Name
Encube Ethicals Private Limited
Address
Encube Advance Research Center, Palava Phase-II, Hedutane Kalyan-421204, Maharashtra, India
Type of Sponsor
Pharmaceutical industry-Global
Details of Secondary Sponsor
Name
Address
Cliantha Research Limited
Cliantha Corporate, TP 86, FP 28/1, Off S P Ring Road, Sarkhej Ahmedabad - 382210 Gujarat, India
1. Male or non-pregnant, non-lactating female aged between 18 to 75 years with a clinical diagnosis of stable plaque psoriasis for at least 6 months prior to the study.
2. BSA involvement greater than or equals to 3 percent and less than or equals to 20 percent (the participants face, scalp, groin, palms and soles should be excluded from the percent of total BSA (percent BSA) calculations) to determine trial participants eligibility.
3. A PGA score for plaque psoriasis of 2 (mild), 3 (moderate) or 4 (severe) at screening and baseline visit.
4. Female participant with postmenopausal status (spontaneous amenorrhea for at least 12 consecutive months) OR surgically sterilized OR female of child bearing potential with a negative pregnancy test must use acceptable methods of contraception throughout the study period and until 4 weeks after the last dose of investigational product.
5. 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.
6. Participant willing to provide written informed consent.
7. Participant willing and able to comply with the procedures and requirements of the study.
ExclusionCriteria
Details
1. Female who is 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. Any sign of infection of any of the psoriatic lesions.
4. 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).
5. Presence of pigmentation, extensive scarring, or pigmented lesions in the treatment areas, which could interfere with the rating of efficacy parameters.
6. History of psoriasis unresponsive to topical treatments and/or biologic treatments.
7. History of hypersensitivity to any component of the test product or reference listed drug.
8. Current immunosuppression
9. Concurrent or medical history of uncontrolled, clinically significant intercurrent medical condition(s):
a. Immunocompromised (eg, lymphoma, acquired immunodeficiency syndrome) or medical history of positive human immunodeficiency virus (HIV) antibody
b. Chronic or acute systemic infection requiring treatment with systemic antibiotics, antivirals, antiparasitic, antiprotozoals, or antifungals within 4 weeks prior to the baseline visit.
c. Acute active bacterial, fungal, or viral (herpes simplex, herpes zoster, chicken pox) skin infection within 1 week prior to the baseline visit.
d. Significant dermatologic or inflammatory condition other than plaque psoriasis that, in the Investigators opinion, would make it difficult to interpret data or assessments during the study.
e. System disorder, organ disorder, cardiovascular, gastrointestinal, hematological, hepatic, neurological, pancreatic, renal disease, severe psychiatric condition, etc. which in the opinion of the investigator, would interfere with optimal participation in the study or produce significant risk to the participant.
10. Use within one month or within 5 half-lives (whichever is longer) prior to baseline of:
a) Systemic steroids
b) Systemic antibiotics
c) Systemic antipsoriatic treatment
d) Vitamin D3 and analogs (greater than 5000 IU/day), retinoids (eg, acitretin, isotretinoin), or adrenocorticotropic hormone analogs
e) Psoralen plus ultraviolet A (PUVA) therapy
f) Ultraviolet B (UVB) therapy
g) Systemic anti-inflammatory agents
h) Any systemic immunosuppressive or immunomodulating agents
11. Use of any of the following therapies within two weeks prior to baseline:
a) Topical anti-psoriatic drugs (e.g., salicylic acid, anthralin, coal tar, calcipotriene, tazarotene)
b) Topical corticosteroids
c) Topical immunosuppressive drugs (e.g., tacrolimus, pimecrolimus)
d) Topical retinoids
12. Clinically significant abnormalities in ECG or Screening laboratory parameters.
13. Participant who has received chemotherapy or radiation therapy and/or anti-neoplastic agents within 3 months prior to screening/baseline.
14. Use of biological treatments for psoriasis within the last 6 months of the baseline evaluation.
15. Within 2 weeks of immunizations with a live viral component; drugs known to possibly worsen psoriasis, such as beta blockers (e.g. propranolol), lithium, iodides, angiotensin converting enzyme inhibitors, and indomethacin, unless on a stable dose for greater than 12 weeks.
16. Current or a history of cancer within 5 years except for fully excised skin basal cell carcinoma, squamous cell carcinoma or carcinoma in situ of the cervix.
17. Participant who consumes excessive amounts of alcohol (greater than two drinks per day) or use drugs of abuse (including, but not limited to, cannabinoids, cocaine and barbiturates) within one year prior to screening.
18. Ultraviolet (UV) light therapy or prolonged exposure to natural or artificial sources of UV radiation (eg, phototherapy, tanning beds/booths, or therapeutic sunbathing) within one month prior to the baseline visit and/or plans to have such exposures during the study.
19. Employees of the Investigator or research center or their immediate family members.
20. Living in the same household of a participant who is currently participating or living in the same household of a participant who has previously participated in the study.
Method of Generating Random Sequence
Other
Method of Concealment
Other
Blinding/Masking
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
Primary Outcome
Outcome
TimePoints
The primary efficacy endpoint is the proportion of participants with treatment success defined as a Physician Global Assessment (PGA) score of clear (0) or almost clear (1) with a minimum 2- grade improvement from baseline to the end of treatment (Week12).
12 weeks
Secondary Outcome
Outcome
TimePoints
1. Body sites and size of treatment area.
2. Proportion of participants with greater than or equals to 75 percent (PASI75) improvement in Psoriasis Area and Severity Index (PASI) from baseline at Week 12
12 weeks
Target Sample Size
Total Sample Size="450" Sample Size from India="450" 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)
11/08/2025
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="4" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Open to Recruitment
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
·This will be a
Randomized, Multicenter, Double-blind, Three-arm, Placebo-controlled, Parallel
Design Study to Evaluate the Bioequivalence (with Clinical Endpoint) of Tapinarof Cream 1 percent of Encube Ethicals Private Limited, India with VTAMA (tapinarof) cream 1 percent of Dermavant Sciences, Inc. in Participants with Plaque
Psoriasis
·Sample size of
the study will be approximately 450 participants; male or non-pregnant, non-lactating
females aged between 18 to 75 years with a clinical diagnosis of stable (at
least 6 months) plaque psoriasis involving BSA greater than or equals to 3 percent and less than or equals to 20 percent (the participants face, scalp, groin, palms and
soles should be excluded from the percent of total BSA (percent BSA) calculations) to
determine trial participants eligibility.
·Participants will receive either Encube
Ethicals Private Limited Tapinarof Cream (n equals to 180), RLD (VTAMA cream 1 percent, n equals to 180) or Placebo (n equals to 90), once daily for 84 days (12 weeks). Participants will take the trial drug
home and self-administer trial drug or have caregiver apply, if necessary, to
affected areas once daily.
·At each contact
with the participant, the investigator will seek information on adverse events
by different safety assessments like physical examination, vital signs and
clinical laboratory investigations etc.
·Telephonic
follow-ups are scheduled between visits to assess AEs and concomitant
medications, to review trial drug application procedure, and to confirm participant
has continued participation in the trial.
End of the Study (EOS) and Follow-up safety assessment
will be conducted one week after EOT Visit through telephonic or in person.