Back to resultsMicroneedling and Latanoprost in Acrofacial Vitiligo
Primary Purpose
Vitiligo
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Latanoprost
Microneedling
Sponsored by
About this trial
This is an interventional treatment trial for Vitiligo focused on measuring acrofacal vitiligo, latanoprost, microneedling
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Microneedling + latanoprost
latanoprost
Arm Description
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).
Patient will receive topical application of latanoprost 0.005% eye drops solution only twice daily for 3 months (active control side).
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03611348
Brief Title
Microneedling and Latanoprost in Acrofacial Vitiligo
Official Title
Effectiveness of Microneedling and Topical Latanoprost in Treatment of Acrofacial Vitiligo
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2018 (Anticipated)
Primary Completion Date
September 1, 2019 (Anticipated)
Study Completion Date
December 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To compare efficacy of topical latanoprost preceded by microneedling versus topical latanoprost alone in treatment of acrofacial vitiligo.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitiligo
Keywords
acrofacal vitiligo, latanoprost, microneedling
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Microneedling + latanoprost
Arm Type
Active Comparator
Arm Description
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).
Arm Title
latanoprost
Arm Type
Active Comparator
Arm Description
Patient will receive topical application of latanoprost 0.005% eye drops solution only twice daily for 3 months (active control side).
Intervention Type
Drug
Intervention Name(s)
Latanoprost
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Microneedling
Intervention Description
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
Primary Outcome Measure Information:
Title
Improvement in VASI score
Description
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).
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Noreen IS Abdelghany, M.B.B.Ch.
Phone
1093744655
Ext
+20
Email
noreen.ismael@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ramadan Saleh, MD
Organizational Affiliation
Sohag University
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Share study proposal, patients and methods, results.
IPD Sharing Time Frame
1 year
IPD Sharing Access Criteria
Permission obtained from study director
Learn more about this trial
Microneedling and Latanoprost in Acrofacial Vitiligo
We'll reach out to this number within 24 hrs