Microneedling and Latanoprost in Acrofacial Vitiligo

NCT03611348 | Unknown Phase 2 DMC

• 1 other identifier: VIT.LT2018
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Vitiligo

Keywords

acrofacal vitiligo, latanoprost, microneedling

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Microneedling + latanoprost

ACTIVE COMPARATOR

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; Device: Microneedling

latanoprost

ACTIVE COMPARATOR

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

Drug: Latanoprost

Interventions

Latanoprost DRUG

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.

Microneedling + latanoprost; latanoprost

Microneedling DEVICE

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

Microneedling + latanoprost

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sohag University: lead

MeSH Terms

Conditions

Vitiligo

Interventions

Latanoprost; Percutaneous Collagen Induction

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Punctures; Rehabilitation

Study Officials

• Ramadan Saleh, MD

  Sohag University

  STUDY DIRECTOR

Central Study Contacts

Noreen IS Abdelghany, M.B.B.Ch.

CONTACT

1093744655; noreen.ismael@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident at general administration of medical affairs

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: July 26, 2018
• First Posted: August 2, 2018
• Study Start: September 1, 2018
• Primary Completion: September 1, 2019
• Study Completion: December 1, 2019
• Last Updated: August 28, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: 1 year
• Access Criteria: Permission obtained from study director