Microneedling Combined With Topical Crisaborole 2 % Ointment in Treatment of Vitiligo.

Microneedling Combined With Topical Crisaborole 2 % Ointment in Treatment of Vitiligo. A Prospective Controlled Trial.

The goal of this clinical trial is to learn if topical crisaborole ointment works to treat vitiligo. It will also learn about the safety of the drug. The main questions it aims to answer are:

Can the drug cause repigmentation of vitiligo lesions when used as topical form after microneedling? What medical problems do participants have when the drug used?

Participants will:

Visit the clinic once every 2 weeks to have the microneedling sessions for 3 months. and also they will have narrow band UVB sessions two times per week.

Record any side effect they have during or after the sessions.

Study Overview

• Status: Not yet recruiting
• Conditions: Vitiligo
• Intervention / Treatment: Procedure: microneedling with topical crisaborole

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients suffer from non-segmental stable vitiligo.
• Patients who will accept to be included in the study and will sign a written consent.

Exclusion Criteria:

• Patients with history of koebnerization or any sign of disease activity.
• Patients with keloid tendency.
• Patients with active infection.
• Pregnant or lactating woman.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: the main patch with microneedling and topical crisaborole and two patches as control; each patient will have 3 vitiligo patches one will be treated by microneedling and topical application of crisaborole and the other 2 patches will be considered as control patches	Procedure: microneedling with topical crisaborole; From each patient 3 patches will be selected The first will have microneedling and topical crisaborole and NB UVB sessions The second will have microneedling and NB UVB sessions The third will be exposed only to NB UVB sessions The microneedling sessions will be every 2 weeks for 6 sessions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Repigmentation of vitiligo lesions	The repigmentation responses will be expressed qualitatively as the following No change (0%-25%) = mild improvement (26%-50%) = moderate improvement (51%-75%) = good improvement (76%-100%) = excellent improvement	3 months from the start of treatment

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2025
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: July 20, 2025
• First Submitted That Met QC Criteria: July 20, 2025
• First Posted (Actual): July 28, 2025

Study Record Updates

• Last Update Posted (Actual): July 30, 2025
• Last Update Submitted That Met QC Criteria: July 25, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Hypopigmentation; Pigmentation Disorders; Vitiligo
• Other Study ID Numbers: 36264MS976/6/25

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No