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Clinical Trials/CTRI/2025/09/094957
CTRI/2025/09/094957Not yet recruitingNot Applicable

Comparative study of Microneedling with Topical 5- Fluorouracil 5 percent cream versus Topical Clobetasol propionate 0.05% in stable vitiligo

Dhyani Vyas1 site in 1 country40 target enrollmentStarted: October 1, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
40
Locations
1
Primary Endpoint
The response to therapies of vitiligo are variable but it is seen that combining medical management with better drug delivery enhancing systems like microneedling will increase the chances of repigmentation leading to better outcome and faster results. Hence, this will help in comparing and finding out a better treatment option for providing safe, effective and easily reproducible option for stable vitiligo, while taking into consideration the side effects observed within 3 months of study.

Study Overview

Brief Summary

Vitiligo is an acquired primary disorder of pigmentation of unknown etiology, characterized clinically by depigmented macules and patches. Stability in vitiligo is defined as the absence of new lesions, no progression of existing lesions, and no occurrence of the Koebner phenomenon over the past year. Current treatment options include topical and systemic medications, phototherapy, laser therapy, and surgical interventions. Combined treatments, which integrate conventional and newer therapeutic methods, have shown superior efficacy, faster response, and better safety profiles compared to monotherapies. Microneedling is employed as a transdermal drug delivery technique to enhance the absorption of topical immunomodulators. The application of a microneedling device creates microchannels or pores in the stratum corneum, facilitating better drug penetration. This technique helps improve drug efficacy and may reduce the duration of treatment. 5-Fluorouracil (5-FU), an antimitotic agent known to stimulate melanocyte migration and proliferation, is being investigated for topical and intradermal use in the treatment of vitiligo. Topical corticosteroids are considered the first-line treatment for vitiligo. They are typically applied once or twice daily over the entire affected lesion and are especially useful in early or localized disease. The primary outcome of the study includes the clinical repigmentation, evaluated using G-score to compare the efficacy of such combined medical and surgical modalities with the standard treatment of vitiligo, that is, topical potent corticosteroid. Hence, this will help in comparing and finding out a better treatment option for providing safe, effective and easily reproducible option for stable vitiligo, while taking into consideration the side effects, if any, observed in the study.

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
None

Eligibility Criteria

Ages
12.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • All cases of stable vitiligo who have given consent for participation in the study and came to Skin OPD of Dhiraj Hospital or being referred from other departments Patients who have not taken treatment or who have stopped all treatment for more than 1 month will be included in the study.

Exclusion Criteria

  • Patients with unstable vitiligo Patients with a history of photosensitive conditions, keloid, hypertrophic scar, Koebner’s phenomenon on the abraded areas will be excluded from the study Pregnant as well as lactating women will be excluded.
  • Patients on treatment with topical or systemic steroids, immunosuppressive therapy, immunomodulators, phototherapy at the time of attending the OPD will be excluded.
  • Lesions over face, intertriginous areas, genitals, palms and soles will be excluded.
  • Patients who have undergone vitiligo surgery recently, for less than 1 year will be excluded.
  • Patients less than 12 years will be excluded.
  • Patients with other skin diseases like eczema, psoriasis or infection which can affect the treatment and the results will also be excluded.
  • Patients with minimal general health will be excluded.
  • Patients with bleeding disorder or coagulopathy will be excluded Patients with hypersensitivity to 5- Fluorouracil or Clobetasol will be excluded Patients with active skin or systemic infections will be excluded Patients with associated disorders like diabetes mellitus, thyroid disorder, atopic dermatitis, pernicious anemia, internal malignancy and neurological disorders will also be excluded.

Outcomes

Primary Outcomes

The response to therapies of vitiligo are variable but it is seen that combining medical management with better drug delivery enhancing systems like microneedling will increase the chances of repigmentation leading to better outcome and faster results. Hence, this will help in comparing and finding out a better treatment option for providing safe, effective and easily reproducible option for stable vitiligo, while taking into consideration the side effects observed within 3 months of study.

Time Frame: Baseline, 1 month, 2 months, 3 months

Secondary Outcomes

  • The response to therapies of vitiligo are variable but it is seen that combining medical management with better drug delivery enhancing systems like microneedling will increase the chances of repigmentation leading to better outcome & faster results. Hence, this will help in comparing & finding out a better treatment option for providing safe, effective & easily reproducible option for stable vitiligo, while taking into consideration the side effects observed at baseline, 1 month, 2 months & 3 months of study(baseline, 1 month, 2 months, 3 months)

Investigators

Sponsor
Dhyani Vyas
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Dhyani Vyas

Sumandeep Vidyapeeth SBKS MIRC

Study Sites (1)

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