CTRI/2026/03/106402 [Registered on: 17/03/2026] Trial Registered Prospectively
Last Modified On:
26/05/2026
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
A study to evaluate the effectiveness and safety of Tapinarof topical cream compared with Tacrolimus ointment for treating moderate to severe atopic dermatitis.
Scientific Title of Study
A prospective, interventional, randomized, multicentric, assessor blinded, active-controlled, parallel-group, non-inferiority clinical trial to evaluate the efficacy, safety, and tolerability of Tapinarof Topical Cream compared with Tacrolimus ointment in patients with moderate to severe atopic dermatitis.
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
CE-25-07 Version: 2.0 Dated 06 Jan 2026
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Jayesh Sanmukhani
Designation
Head - Medical Services
Affiliation
Clinexcel Research
Address
297, SoBo Centre, South Bopal, Ahmedabad, Gujarat 380058
Ahmadabad GUJARAT 380058 India
Phone
7600012192
Fax
Email
drjayesh@clinexcelresearch.com
Details of Contact Person Scientific Query
Name
Dr Kanaiyalal Prajapati
Designation
General Manager, Clinical Research
Affiliation
Emcure Pharmaceuticals Ltd.
Address
Emcure Pharmaceuticals Ltd., India., FP-67, TP-44, Behind Ishan Square, Nr. Tapovan Circle, Visat-Gandhinagar Highway, Chandkheda, Ahmedabad, 382424, India.
Ahmadabad GUJARAT 382424 India
Phone
9099060474
Fax
Email
kanaiyalal.praiapati@emcure.com
Details of Contact Person Public Query
Name
Dr Jayesh Sanmukhani
Designation
Head - Medical Services
Affiliation
Clinexcel Research
Address
297, SoBo Centre, South Bopal, Ahmedabad, Gujarat 380058
Ahmadabad GUJARAT 380058 India
Phone
7600012192
Fax
Email
drjayesh@clinexcelresearch.com
Source of Monetary or Material Support
Emcure Pharmaceuticals Ltd., India.
Plot No. P1 & P2, ITBT Park, MIDC, Phase II, Hinjewadi, Pune 411057, India.
Primary Sponsor
Name
Emcure Pharmaceuticals Limited
Address
Emcure Pharmaceuticals Ltd., India.
Plot No. P1 & P2, ITBT Park, MIDC, Phase II,
Hinjewadi, Pune 411057, India.
OPD Room ,1st Floor, Department of Dermatology,
BBSR AIIMS, Khordha, Orissa- 751019
Khordha ORISSA
9437742488
arpita@aiimsbhubaneswar.edu.in
Dr Revathi Vavilapalli
Government Medical College and Government General Hospital
Room Number 16, 3rd Floor, Department of Dermatology, Srikakulam, Andhra Pradesh 532001.
Srikakulam ANDHRA PRADESH
9908066043
drrevathivggh@gmail.com
Dr Trusha Janak Gajjar
Harshil Medical Nursing Home
Clinical Study Room 2nd Floor, 19, Asha Society, Near Verai Mata Temple, Near Isanpur Bus Stop, Isanpur-Bhairavnath Road, Isanpur, Ahmedabad, Gujarat 382443
Ahmadabad GUJARAT
9537218298
hmnhcr@gmail.com
Dr Nibedita Patro
Hi-Tech Medical College and Hospital
OPD Room , Ground Floor, Department of Skin, Health Park Pandara,
Rasulgarh, Bhubaneswar Khordha
Orissa – 751025
Khordha ORISSA
9937740401
nibeditapatro@gmail.com
Dr Rajkumar Kothiwala
Jawahar Lal Nehru Medical College
Room Number 34, GF, Medicine Building, Dermatology Department, Kala Bagh, Ajmer – 305001, Rajasthan.
Ajmer RAJASTHAN
9414118811
drrkkothiwala@gmail.com
Dr Asha Kiran Alajangi
Medigene Multispecialty Hospital
1st Floor, Room Number 3, Dermatology Department, Railway New Colony, Visakhapatnam, Andhra Pradesh.
Visakhapatnam ANDHRA PRADESH
9440037979
bioexperts21@gmail.com
Dr Bansri Mahadevia
Medilink Hospital and Research Centre
1st Floor, Room Number-03, Clinical Research Department, Nr. Shyamal Cross Road, 132 Ft. Ring Road, Satellite, Ahmedabad-380015 Gujarat, India.
Ahmadabad GUJARAT
8141745369
bethechangeclinic@gmail.com
Dr Mukta Sharma
Mitras Multispecialty Hospital
1,Tilak Road, Ward No-12, Hakim Para, Siliguri-734001, District-Darjeeling, West Bengal. Darjiling WEST BENGAL
7602255163
mukta1454@gmail.com
Dr Dipankar De
Post Graduate Institute of Medical Education and Research Hospital
Room Number 5007, 5th Floor, New OPD Building, Sector-12, Chandigarh -160012, India.
Chandigarh CHANDIGARH
9316123724
dr_dipankar_de@yahoo.in
Dr B C Ghiya
Sardar Patel Medical College and AG hospital
Room Number 1, Department of Dermatology, Ground Floor, Bikaner-334001, India
Bikaner RAJASTHAN
Tacrolimus ointment 0.03 percent or 0.1 percent will be applied topically to affected areas twice daily. Participants aged 2 to 15 years will apply Tacrolimus ointment 0.03 percent, whereas participants aged 16 years and above will apply Tacrolimus ointment 0.1 percent for 56 days.
Intervention
Tapinarof topical cream 1 percent
Tapinarof topical cream 1 percent will be applied topically to affected areas once daily for 56 days.
1.Male or female participants 2 years and above (Cohort 2: pediatric participants 2 to less than 18 years; Cohort 1: adult participants 18 years and above).
2.Clinical diagnosis of atopic dermatitis (atopic eczema) confirmed according to the diagnostic criteria of Hanifin and Rajka, as determined by the investigator.
3.Participants with body surface area involvement 5 to 35 percent, with vIGA-AD score 3 or higher and EASI score 7.1 or higher, consistent with moderate to severe atopic dermatitis at screening and baseline.
4.Generally good health apart from atopic dermatitis, based on medical history, physical examination, and screening laboratory tests.
5.Willingness and ability to apply the study medication as directed, maintain permitted skin care routines, and avoid prohibited treatments during the study.
6.Willingness to attend all scheduled visits, comply with follow-up schedules, and complete study diary requirements.
7.The participant and or their parent or legal guardian is willing and able to provide signed informed consent additional written assent for 12 to less than 18 years age group and oral assent for 7 to less than 12 years age group prior to any study related procedures to be performed.
ExclusionCriteria
Details
1.Participants with any clinically significant immunocompromised state, including primary immunodeficiencies, active malignancy, lymphoma, or acquired immunodeficiency syndrome AIDS, or those receiving systemic immunosuppressive therapy within 4 weeks prior to screening.
2.Current active infection at baseline, including clinically infected AD lesions, or a serious infection within the past 4 weeks requiring hospitalization and or intravenous anti infective therapy, or systemic anti infectives within 2 weeks prior to baseline.
3.Presence of dermatologic conditions other than AD for example psoriasis, rosacea, ichthyosis, erythroderma, Netherton syndrome, generalized eczema, extensive scarring, or severe sunburn that, in the opinion of the investigator, may interfere with study assessments or safety evaluation.
4.Lesion distribution limited to areas unsuitable for standard assessment for example only scalp, palms, or soles without other evaluable sites.
5.Clinically significant hepatic, renal or thyroid abnormalities at screening, including alanine aminotransferase ALT or aspartate aminotransferase AST 2 times or more the upper limit of normal ULN, total bilirubin more than 1.5 times ULN, serum creatinine more than 1.5 times ULN, TSH more than ULN.
6.History of malignancy within 5 years prior to screening.
7.Positive test for hepatitis B surface antigen HBsAg, hepatitis C virus HCV, or human immunodeficiency virus HIV infection at screening.
8.Use of prohibited medications or procedures prior to baseline:
8.1 Biologics for AD: 5 half lives or 12 weeks whichever is longer.
8.2 Systemic immunomodulators, systemic corticosteroids, phototherapy UVA, UVB, PUVA, or topical or oral Janus kinase JAK inhibitors: 4 weeks.
8.3 Topical corticosteroids, topical calcineurin inhibitors, topical phosphodiesterase 4 PDE 4 inhibitors, Tapinarof, or other topical prescription medications to treatment areas: 1 week.
8.4 Systemic antibiotics, antifungals, antivirals, or antiparasitics: 2 weeks.
8.5 Topical antibiotics or antifungals applied to treatment areas: 1 week.
9.Receipt of any live or live-attenuated vaccine within 4 weeks prior to baseline or planned during the study period.
10.Pregnant or lactating females, females of childbearing potential or male participants with partners of childbearing potential who are unwilling to use an acceptable method of contraception during the study.
11.Known hypersensitivity to Tapinarof Topical Cream 1 percent or Tacrolimus ointment 0.03 percent or 0.1 percent or to any excipients in the Tapinarof Topical Cream 1 percent or Tacrolimus ointment 0.03 percent or 0.1 percent formulation.
12.Participants who would not be considered suitable for topical therapy for atopic dermatitis.
13.Participation in another interventional clinical trial within 4 weeks or 5 half lives of the investigational product whichever is longer prior to baseline.
14.History of alcohol or drug abuse within 1 year prior to screening.
15.Any uncontrolled chronic illness or clinically significant medical, psychiatric, or laboratory abnormality that, in the investigator judgment, may pose additional risk, interfere with study participation, or confound interpretation of study results.
16.Any other reason that, in the opinion of the investigator, makes the participant unsuitable for participation in the study.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
An Open list of random numbers
Blinding/Masking
Outcome Assessor Blinded
Primary Outcome
Outcome
TimePoints
1.Proportion of participants achieving a validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of clear (0) or almost clear (1) with at least a 2-grade or more improvement.
Baseline (Visit 2) to Visit 6 (Day 56)
Secondary Outcome
Outcome
TimePoints
Proportion of participants achieving 50 percent (EASI-50), 75 percent (EASI-75), and 90 percent (EASI-90) improvement from baseline in Eczema Area and Severity Index (EASI) score.
At Day 28 (Visit 4) to Day 56 (Visit 6)
Mean percentage change from baseline in Eczema Area and Severity Index (EASI) score.
Baseline (Visit 2) to Day 28 (Visit 4) and Day 56 (Visit 6).
Proportion of participants achieving a validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of clear (0) or almost clear (1) with at least a 2 grade improvement.
Baseline (Visit 2) to Day 28 (Visit 4).
Mean change from baseline in percentage of Body Surface Area affected by atopic dermatitis.
From Baseline (Visit 2) to Day 28 (Visit 4) and Day 56 (Visit 6).
Mean percentage change from baseline in the SCORing Atopic
Dermatitis index (SCORAD) total score
From Baseline (Visit 2) to Day 28 (Visit 4) and Day 56 (Visit 6).
Proportion of participants with a baseline Peak Pruritus Numeric Rating Scale (PP-NRS) score of 4 or more who achieve a 4 point or greater reduction in average weekly Peak Pruritus Numeric Rating Scale (PP-NRS)score.
From Baseline (Visit 2) to Day 28 (Visit 4) and Day 56 (Visit 6).
Mean change from baseline in Sleep Disturbance Numeric Rating Scale (SD-NRS) score.
From Baseline (Visit 2) to Day 14 (Visit 3) Day 28 (Visit 4) day 42 (Visit 5) and Day 56 (Visit 6).
Proportion of patients withdrawn due to lack of efficacy
Up to Day 56 (End of Study).
Target Sample Size
Total Sample Size="286" Sample Size from India="286" 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
Phase 3
Date of First Enrollment (India)
28/03/2026
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="6" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Not Yet Recruiting
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 is a multicenter, prospective, randomized, assessor-blinded, active-controlled, parallel-group, non-inferiority Phase III clinical study designed to evaluate the efficacy, safety, and tolerability of Tapinarof topical cream compared with Tacrolimus ointment in patients with moderate to severe atopic dermatitis. Potentially eligible patients including adults aged 18 years and above and pediatric patients aged 2 years to less than 18 years with a clinical diagnosis of atopic dermatitis will be screened up to 7 days prior to enrollment to confirm eligibility based on protocol defined inclusion and exclusion criteria.
Following baseline clinical and laboratory assessments, participants will be randomized in a one to one ratio at Day 0 to receive either Tapinarof topical cream 1 percent (test) applied topically once daily or Tacrolimus ointment 0.03 percent or 0.1 percent (reference) applied topically twice daily to affected areas for a treatment period of 56 days.
Participants will be evaluated at scheduled visits on Day 14, Day 28, Day 42, and Day 56 for efficacy assessments including validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD), Scoring Atopic Dermatitis (SCORAD), Eczema Area and Severity Index (EASI), percentage of body surface area affected, Peak Pruritus Numeric Rating Scale, and Sleep Disturbance Numeric Rating Scale. Safety assessments will include monitoring of adverse events, vital signs, physical examinations, and laboratory evaluations.
Efficacy and safety data will be analyzed using descriptive and inferential statistical methods to evaluate the incidence, magnitude, and clinical relevance of treatment effects in the Tapinarof topical cream 1 percent group compared with the Tacrolimus ointment 0.03 percent or 0.1 percent reference group.