| CTRI Number |
CTRI/2025/04/083785 [Registered on: 01/04/2025] Trial Registered Prospectively |
| Last Modified On: |
27/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Other (Specify) [Dermabrasion followed by application of tacrolimus cream and dinoprostone ointment] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To assess the effectiveness and safety of dermabrasion followed by tacrolimus and dermabrasion followed by dinoprostone in stable vitiligo patients. |
|
Scientific Title of Study
|
A comparative study to evaluate the efficacy and safety of dinoprostone and tacrolimus following dermabrasion in the treatment of stable vitiligo. |
| 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 Monika V |
| Designation |
Postgraduate |
| Affiliation |
Bangalore medical college and research institute |
| Address |
Department of dermatology, Bangalore medical college, fort, kr road, kalasipalya, 560002.
Bangalore KARNATAKA 560002 India |
| Phone |
9632470190 |
| Fax |
|
| Email |
drmonikavasanth@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Shilpa K |
| Designation |
Professor and head |
| Affiliation |
Bangalore medical college and research institute |
| Address |
Department of dermatology, Bangalore medical college, fort, kr road, kalasipalya, 560002.
Bangalore KARNATAKA 560002 India |
| Phone |
9886553646 |
| Fax |
|
| Email |
shilpakvinod1980@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Shilpa K |
| Designation |
Professor and head |
| Affiliation |
Bangalore medical college and research institute |
| Address |
Department of dermatology, Bangalore medical college, fort, kr road, kalasipalya, 560002.
KARNATAKA 560002 India |
| Phone |
9886553646 |
| Fax |
|
| Email |
shilpakvinod1980@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bangalore medical college and research institute. Fort, Krishna Rajendra road, Kalasipalya, Bengaluru, Karnataska, 560002 |
|
|
Primary Sponsor
|
| Name |
Dr Monika V |
| Address |
Department of dermatology, Bangalore medical college and research institute, fort, kr road, kalasipalya, 560002 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Monika V |
Bangalore medical college and research institute. |
Department of dermatology, Bangalore medical college and research institute, fort, kr road, kalasipalya, 560002 Bangalore KARNATAKA |
9632470190
drmonikavasanth@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee , bangalore medical college and research institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L80||Vitiligo, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dermabrasion followed by 0.1% tacrolimus ointment. |
One session of dermabrasion followed by 0.1% tacrolimus ointment followed by twice daily application of 0.1% tacrolimus ointment for 6 months |
| Intervention |
Dermabrasion followed by 0.5mg/3g Dinoprostone gel. |
One session of dermabrasion followed by 0.5mg/3g dinoprostone gel followed by twice daily application of 0.5mg/3g dinoprostone gel for 6 months |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients willing to give informed consent.
2.Patient of either gender aged more than 15yrs
3.Patients willing for follow up
4. Patients with clinically diagnosed Stable Vitiligo
|
|
| ExclusionCriteria |
| Details |
1.Patient not willing to give informed consent
2.Patients having unstable vitiligo
3.Pregnant and lactating females
4.Patients having keloidal tendency
5.Patients having documented hypersensitivity to lignocaine, tacrolimus and dinoprostone.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in vitiligo area severity index (VASI). |
Change in vitiligo area severity index (VASI) at: 4,8,12,16,20 and 24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Safety. |
Adverse effects at: 4,8,12,16,20 & 24 weeks. |
|
|
Target Sample Size
|
Total Sample Size="52" Sample Size from India="52"
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)
|
04/05/2025 |
| 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="1" Months="0" 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
|
Dermabrasion is a commonly used surgical modality in the
treatment of stable vitiligo. This minimal invasive method can be combined with
various topical therapies for better drug penetration hence better results. As vitiligo is proposed to be a result of autoimmunity, topical
immunomodulator drugs like Calcineurin inhibitors like pimecrolimus and
tacrolimus are used in treatment of vitiligo. There is increased
expression of various Prostaglandin receptors like Prostaglandin E2(PGE2) type1
and 3 over melanocytes. PGE2 analogue like Dinoprostone was used in the
treatment of vitiligo in the year 2002. Combination
of dermabrasion and topical agents have given better results in few clinical
studies. Here the aim of study is
to compare and evaluate Tacrolimus and Dinoprostone following dermabrasion in
the treatment of stable vitiligo using VASI (Vitiligo Area Scoring Index) and
record adverse effects if any. Based on the previous study conducted by Kaur J et al, after 24 weeks, Grade 4 repigmentation in Group A and Group B are 25% and 0% respectively, sample size was calculated and found to be 52. After obtaining approval and clearance from the institutional ethics committee, the patients fulfilling the inclusion criteria will be enrolled for the study after obtaining informed consent. A detailed clinical history will be taken in terms of demographic data, age, sex, occupation, presenting complaints, past history, treatment history, family history duration of skin lesions, course and progression of disease and clinical examination findings will be recorded in the case record form. Appropriate photographs will be taken at each visit with informed consent. After detailed history taking and thorough clinical examination, patients diagnosed with Stable Vitiligo will be allocated into two study groups of 26 each, randomized in 1:1 ratio using computer random sequence generator. Patients in both groups A and B will be taken up for Dermabrasion and following steps will be done: · A desired area of depigmented vitiligo patch is selected. · Patch is sterilized using povidine iodine solution. · Patch is anesthetized using 2% lignocaine injection. · Using Manekshaw’s dermabrader, dermabrasion is done 3-4 times in each direction horizontally, vertically and diagonally until pinpoint bleeding occurs. · Hemostasis is achieved and following treatment is given for each group. a. Group A patients will be taken up for tacrolimus 0.1% ointment application. b. Group B patients will be taken up for Dinoprostone 0.5mg/3g gel application. After application of topical creams, dressing is done. Patients are advised to remove dressing after 24 hours and then are advised to apply tacrolimus 0.1% ointment twice daily and Dinoprostone 0.5mg/3g gel twice daily in group A and B respectively. Patients will be given oral analgesics, Tab.Paracetamol 500mg, as needed. This drug does not interfere with the topicals used in the study. Patients will be followed up on Day 3 and Day 7 for assessment of any side effects. VASI (Vitiligo Area Severity Index) will be assessed at weekly intervals from week 4 to 24 along with simultaneous serial digital photographs and recording of side effects if any.
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