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Microneedling and Latanoprost in Acrofacial Vitiligo

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ClinicalTrials.gov Identifier: NCT03611348
Recruitment Status : Not yet recruiting
First Posted : August 2, 2018
Last Update Posted : August 28, 2018
Sponsor:
Information provided by (Responsible Party):
Noreen Ismail AbdelGhani Ahmed, Sohag University

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of Microneedling and Topical Latanoprost in Treatment of Acrofacial Vitiligo
Estimated Study Start Date : September 1, 2018
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitiligo
Drug Information available for: Latanoprost

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.




Primary Outcome Measures :
  1. 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:

    • 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).




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03611348


Contacts
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Contact: Noreen IS Abdelghany, M.B.B.Ch. 1093744655 ext +20 noreen.ismael@yahoo.com

Sponsors and Collaborators
Sohag University
Investigators
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Study Director: Ramadan Saleh, MD Sohag University

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Responsible Party: Noreen Ismail AbdelGhani Ahmed, resident at general administration of medical affairs, Sohag University
ClinicalTrials.gov Identifier: NCT03611348     History of Changes
Other Study ID Numbers: VIT.LT2018
First Posted: August 2, 2018    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Share study proposal, patients and methods, results.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: 1 year
Access Criteria: Permission obtained from study director

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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
Keywords provided by Noreen Ismail AbdelGhani Ahmed, Sohag University:
acrofacal vitiligo, latanoprost, microneedling
Additional relevant MeSH terms:
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Vitiligo
Hypopigmentation
Pigmentation Disorders
Skin Diseases
Latanoprost
Ophthalmic Solutions
Pharmaceutical Solutions
Antihypertensive Agents