Microneedling and Latanoprost in Acrofacial Vitiligo

Vitiligo Clinical Trial

Official title:

Effectiveness of Microneedling and Topical Latanoprost in Treatment of Acrofacial Vitiligo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03611348
• Other study ID #: VIT.LT2018
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: September 1, 2018
• Est. completion date: December 1, 2019

Study information

• Verified date: August 2018
• Source: Sohag University
• Contact: Noreen IS Abdelghany, M.B.B.Ch.
• Phone: 1093744655
• Email: noreen.ismael[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To compare efficacy of topical latanoprost preceded by microneedling versus topical latanoprost alone in treatment of acrofacial vitiligo.

Description:

patients meeting inclusion and exclusion criteria presented to Dermatology Outpatient Clinic, Sohag University Hospital will be enrolled in the study after obtaining a written consent from them. Full history will be obtained and meticulous examination will be carried out. Patients will be randomly divided into 2 groups, one group will receive topical latanoprost with microneedling, and the other one will receive topical latabnoprost alone.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: December 1, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Acrofacial stable vitiligo for 6 months duration (without new lesions appearance or change in size of the existing lesions).

Exclusion Criteria:

• History of scar formation.

• Patients with systemic diseases (diabetes, bleeding disorders, chronic renal diseases, chronic liver diseases, asthma and hypertension).

• Patients who are receiving chemotherapy or radiotherapy.

• Pregnant and lactating females.

Related Conditions & MeSH terms

• Vitiligo

Intervention

Drug:
• Latanoprost
Topical application of latanoprost 0.005% eye drops solution only twice daily for 3 months. To apply latanoprost solution, one drop of the solution will be distributed over 1cm2 of depigmented skin. Side effects will be recorded.

Device:
• Microneedling
A superficial micro-needling technique will be done in millimeters according to depth of skin. The vitiliginous area and a thin surrounding rim (about 2 mm) will be subjected to micro-needling with dermapen. The depth of abrasion will be guided by the depth adjustor according to depth of skin on the affected area. This will be followed by the appearance of multiple, tiny, punctate, bleeding points

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in VASI score	VASI score: The percentage of vitiligo involvement is calculated in terms of hand units. One hand unit is approximately equivalent to 1% of the total body surface area. The degree of pigmentation is estimated to 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 depigmented areas are equal; 25% - pigmented area exceeds depigmented 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 = S All body sites [Hand Units] x [Residual depigmentation]. (Feily et al., 2014).	6 months