Microneedling and Latanoprost in Acrofacial Vitiligo
August 26, 2018 updated by: Noreen Ismail AbdelGhani Ahmed, Sohag University
Effectiveness of Microneedling and Topical Latanoprost in Treatment of Acrofacial Vitiligo
To compare efficacy of topical latanoprost preceded by microneedling versus topical latanoprost alone in treatment of acrofacial vitiligo.
Study Overview
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 Type
Interventional
Enrollment (Anticipated)
70
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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).
|
Topical application of latanoprost 0.005% eye drops solution only twice daily for 3 months.
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).
|
Topical application of latanoprost 0.005% eye drops solution only twice daily for 3 months.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Improvement in VASI score
Time Frame: 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:
Total body VASI = S All body sites [Hand Units] x [Residual depigmentation]. (Feily et al., 2014). |
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
September 1, 2018
Primary Completion (Anticipated)
September 1, 2019
Study Completion (Anticipated)
December 1, 2019
Study Registration Dates
First Submitted
July 26, 2018
First Submitted That Met QC Criteria
July 26, 2018
First Posted (Actual)
August 2, 2018
Study Record Updates
Last Update Posted (Actual)
August 28, 2018
Last Update Submitted That Met QC Criteria
August 26, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VIT.LT2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
Share study proposal, patients and methods, results.
IPD Sharing Time Frame
1 year
IPD Sharing Access Criteria
Permission obtained from study director
IPD Sharing Supporting Information Type
- Study Protocol
- Informed Consent Form (ICF)
- Clinical Study Report (CSR)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.