Microneedling and Latanoprost in Acrofacial Vitiligo

Sponsor

Sohag University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03611348

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Vitiligo	Drug: Latanoprost Device: Microneedling	Phase 2/Phase 3

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized controlled trialRandomized controlled trial

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Effectiveness of Microneedling and Topical Latanoprost in Treatment of Acrofacial Vitiligo

Anticipated Study Start Date :

Sep 1, 2018

Anticipated Primary Completion Date :

Sep 1, 2019

Anticipated Study Completion Date :

Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Microneedling + latanoprost patient will receive topical application of latanoprost 0.005% eye drops solution twice daily for 3 months preceded by microneeding in sessions by dermapen every 2 weeks for 3 months (totally 6 sessions).	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
Active Comparator: latanoprost Patient will receive topical application of latanoprost 0.005% eye drops solution only twice daily for 3 months (active control side).	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.

Arm

Intervention/Treatment

Active Comparator: Microneedling + latanoprost

patient will receive topical application of latanoprost 0.005% eye drops solution twice daily for 3 months preceded by microneeding in sessions by dermapen every 2 weeks for 3 months (totally 6 sessions).

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

Active Comparator: latanoprost

Patient will receive topical application of latanoprost 0.005% eye drops solution only twice daily for 3 months (active control side).

Drug: Latanoprost

Outcome Measures

Primary Outcome Measures

Improvement in VASI score [6 months]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Sohag University

Investigators

Study Director: Ramadan Saleh, MD, Sohag University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Noreen Ismail AbdelGhani Ahmed, resident at general administration of medical affairs, Sohag University

ClinicalTrials.gov Identifier:

NCT03611348

Other Study ID Numbers:

VIT.LT2018

First Posted:

Aug 2, 2018

Last Update Posted:

Aug 28, 2018

Last Verified:

Aug 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Noreen Ismail AbdelGhani Ahmed, resident at general administration of medical affairs, Sohag University

acrofacal vitiligo, latanoprost, microneedling

Additional relevant MeSH terms:

Vitiligo

Latanoprost

Study Results

No Results Posted as of Aug 28, 2018