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CTRI Number  CTRI/2025/07/091090 [Registered on: 17/07/2025] Trial Registered Prospectively
Last Modified On: 19/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Exploring two topical skin creams for Vitiligo - Crisaborole vs Mometasone Furoate  
Scientific Title of Study   To evaluate the efficacy and safety of 2 percent Crisaborole Ointment versus 0.1 percent Mometasone Furoate Cream in Vitiligo - A Comparative Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Saoji Ojasvi Virendra 
Designation  Post-graduate Junior Resident 
Affiliation  Chettiand Hospital and Research Institute 
Address  Department of Dermatology, Venereology and Leprosy OP-18 Chettinad Hospital and Research Institute, Chettiand health city , Rajiv Gandhi Salai(OMR) Kelambakkam chennai Tamil Nadu

Kancheepuram
TAMIL NADU
603103
India 
Phone  9545469455  
Fax    
Email  ojasvisaoji@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Gopalakrishnan 
Designation  Professor and HOD 
Affiliation  Chettiand Hospital and Research Institute 
Address  Department of Dermatology, Venereology and Leprosy OP-18 Chettinad Hospital and Research Institute, Chettiand health city , Rajiv Gandhi Salai(OMR) Kelambakkam chennai Tamil Nadu

Kancheepuram
TAMIL NADU
603013
India 
Phone  9884070883  
Fax    
Email  dermdrgopalakrishnan@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Gopalakrishnan 
Designation  Professor and HOD 
Affiliation  Chettiand Hospital and Research Institute 
Address  Department of Dermatology, Venereology and Leprosy OP-18 Chettinad Hospital and Research Institute, Chettiand health city , Rajiv Gandhi Salai(OMR) Kelambakkam chennai Tamil Nadu

Kancheepuram
TAMIL NADU
603013
India 
Phone  9884070883  
Fax    
Email  dermdrgopalakrishnan@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr Saoji Ojasvi Virendra 
Address  Department of Dermatology, Venereology and leprosy OP NO -18 chettinad hospital and research Institute , chettinad Health City Rajiv gandhi Salai (OMR) kelambakkam ,chennai tamil nadu 603103 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Gopalakrishnan  Chettinad Hospital and Research Institute, Chettinad Academy of Research and Education  Department of Dermatology, Venereology and leprosy OP NO -18 chettinad hospital and research Institute , chettinad Health City Rajiv gandhi Salai (OMR) kelambakkam ,chennai tamil nadu 603103
Kancheepuram
TAMIL NADU 		 09884070883

dermdrgopalakrishnan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Chettinad Academy of Research and Education, Institutional Human Ethics Committee for Student Research(CARE-IHEC-I)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L80||Vitiligo,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  0.1 percent Mometasone Furoate Ointment  Total 40 patients will be divided randomly in 2 groups- other 20 patients will be using 0.1percent mometasone furoate ointment for a period of 8 months 
Intervention  2 percent Crisaborole ointment  Total 40 patients will be divided randomly in 2 groups - 20 patients will be asked to use 2percent crisaborole ointment on focal vitiligo patches for a period of 8 months 
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients who are willing to undergo topical
therapy with their signed informed consent. The percentage of body surface area affected by vitiligo is less than 20 percent.
Patients who did not take any vitiligo therapy for 2 months before the study.  
 
ExclusionCriteria 
Details  Cases of post inflammatory hypopigmentation. Lesions involving mucosal area.
Pregnant and lactating women.
Allergy or hypersensitivity to PDE4 inhibitors or steroids.
Known history of malignancy, immunodeficiency, cardiovascular diseases, impaired renal or liver functions.
Patients with signs of skin atrophy. Patients lost to follow up after initial visits.  
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To compare effectiveness, safety and adverse effects of 2 percent Crisaborole versus 0.1 percent Mometasone Furoate Cream in vitiligo.   outcome will be assessed/estimated i.e. at baseline, 4 weeks and 8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   31/07/2025 
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="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
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  
INTRODUCTION
Vitiligo is a common autoimmune condition, mostly chronic pigmentation disorder that causes depigmentation of the skin, often due to degeneration or absence of melanocytes of involved skin and affected hair. It is clinically manifested by achromic macules often associated with leukotrichia (white hairs). Vitiligo commonly involves type 3 and 4 skin types but can occur in any skin type. . While most bilateral non-dermatomal lesions start in the second to fourth decades of life, if the disease manifests within ten years of age, it usually appears along the dermatome. Almost half of the patients develop this disease before 20 years of age. Approximately 1-2 PERCENTof the general population is affected irrespective of age, sex or ethnicity. Although vitiligo is difficult to treat various modalities for treatment are present. Various hypothesis have been put forward for the pathogenesis of this condition. One hypothesis suggests that high amounts of pro-inflammatory cytokines cause oxidative stress and inflammation, worsening melanocyte survival and increasing cytotoxicity. So we need to reduce pro-inflammatory cytokines and increase anti-inflammatory cytokines. Twenty vitiligo patients tissue and serum samples had considerably greater PDE4 enzyme levels than those of age- and sex-matched healthy controls. PDE4-dependent pathways could therefore be crucial to the pathophysiology of vitiligo. Crisaborole is a small molecule boron-based, PDE4 inhibitor approved as a topical nonsteroidal medication by FDA. Due to this inhibition cAMP levels will increase, which will cause an increase in anti-inflammatory cytokines which will cause an increase in anti-inflammatory cytokines like IL-10, and a decrease in pro-inflammatory cytokines like IL-17, IL-4, and IL-13. Mometasone Furoate is a class IV nonfluorinated corticosteroid with high potency and safe records. It will reduce inflammatory cells, chemical mediators, and reduce secretion of cytokines such as IL-2 &TNF 

 STUDY OBJECTIVE
To compare effectiveness , safety and adverse effects of 2% Crisaborole versus 0.1 %Mometasone Furoate Cream in vitiligo.
STUDY DESIGN -Randomized controlled trial 
 NUMBER OF STUDY SIZE- Minimum Sample size required is 40
Study Methodology or Procedure 

 INCLUSION CRITERIA: Patients who are willing for topical corticosteroids/topical crisaborole therapy with their signed informed consent. 
Percentage of body surface area affected by vitiligo < 20%. 
Male and female ( both ) patients will be included of age group 10 - 60 years.
 Patients who did not take any vitiligo therapy for 2 months prior to the study.

 EXCLUSION CRITERIA: Cases of post inflammatory hypopigmentation. Lesions involving the mucosal area. Pregnant and lactating women. Allergy or hypersensitivity to PDE4 inhibitors or steroids. Known history of malignancy, immunodeficiency, cardiovascular diseases, impaired renal and/or liver functions. Patients with signs of skin atrophy. Patients lost to follow-up after initial visits. 

METHODS AND METHODOLOGY • Patients who fulfil the inclusion criteria will be allocated to the study 
• Patients will be divided randomly in 2 groups - 20 patients will be asked to use 2% crisaborole ointment on focal vitiligo patches and other 20 patients will be using 0.1% mometasone furoate ointment . 
• Informed consent will be obtained from the patient in their regional language after explaining the study in detail to them
 • A detailed history, which includes the patient’s personal history, past medical and surgical history, allergy history, family history, and history of current medications (topical and systemic), will be noted. 
• After thorough history taking, a general physical examination will be done. 
• At the time of follow-up following points will be looked at in the patients 
• The patients were followed up at their first month  and then at 2,4,6,8 months.
 • Patients were asked for the development of any new lesions or increase in the size of previous lesions. • Patients will also be asked if they felt any improvement/color change in the lesions. • Side effects were assessed at each follow-up. 
• Photos of the lesions of every patient are taken and documented for further reference and evaluation. • 

The Vitiligo Area Scoring Index (VASI) was used to assess the effectiveness of treatment. It was recorded at the baseline and at each follow-up. Vitiligo Area Severity Index (VASI) The percentage of vitiligo involvement is calculated in terms of hand units. One hand unit (which encompasses the palm plus the volar surface of all digits) is approximately equivalent to 1% of the total body surface area. The degree of pigmentation is estimated to be the nearest of one of the following percentages 100% Complete depigmentation, no pigment is present 90%- Specks of pigment present 75% depigmented area exceeds the pigmented area 50%- pigmented and depigmeted areas are equal 25%- pigmented area exceeds depigmeted area 10%- only specks of depigmentation present The VASI for each body region is determined by the product of the area of vitiligo in hand units and the extent of depigmentation within each hand unit measured patch Total body VASI = All body sites [Hand Units] × [Residual depigmentation] . Study outcome or end point.
 STUDY OUTCOME OR END POINTS - 1)Though vitiligo is common in our country, it is challenging to treat despite of many medical and surgical treatments both of them having their benefits and side effects. So it is imperative to choose a drug, that can be used for the long term and should have minimal side effects. 
2) While corticosteroids like mometasone furoate are standard for vitiligo, long-term use has side effects like skin thinning, tachyphylaxis, and post-inflammatory hypo or hyperpigmentation. PDE4 inhibitors such as crisaborole may offer a steroid-sparing alternative, but their role in vitiligo is not well studied. Studies on combined or comparative efficacy between these treatments in vitiligo are limited, representing a significant gap in the literature.
 3) Exploring crisaborole’s role in vitiligo could introduce a novel mechanism of action for treatment, leveraging its anti-inflammatory properties while minimizing side effects. Comparing it with mometasone furoate ensures the study addresses a clinical standard, providing valuable insights for treatment decisions. 
4) If crisaborole demonstrates comparable or superior efficacy to mometasone furoate, it could become an important addition to the treatment arsenal for vitiligo. The study could establish the basis for combination therapies or rotational treatments to mitigate steroid-related adverse effects. Findings could influence future guidelines and improve the quality of life for vitiligo patients.

 Ethical Consideration 
Ethical committee approval will be obtained from the Institutional Human Ethics Committee(IHEC) at Chettinad Hospital And Research Institute before starting study. Consent Informed written consent will be collected from all participants. Informed and written consent will be obtained from parents and children less than 18 years , willing to take part in study . 
 Data confidentiality and participant anonymity will be maintained throughout the study.

Study Duration (in Months / Years - 8 months


 
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