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Latanoprost Plus NB-UVB Versus Each Alone in Non-segmental Vitiligo: Clinical and Laboratory Evaluation

Primary Purpose

Non-segmental Vitiligo

Status
Active
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
NB-UVB
Latanoprost
Sponsored by
Shaimaa Fawzy Abdel-rady Abdel-latif
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-segmental Vitiligo

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients with non-segmental vitiligo of any age and gender.

Exclusion Criteria:

  • History of vitiligo treatment with topical, systemic or biological agents prior to the study for at least 3 weeks.
  • Pregnancy and lactation.
  • Infections
  • Patients with other autoimmune diseases.
  • Patients with chronic diseases: cardiac diseases, hepatic disorders, hematologic disease, chronic renal failure or malignancies.

Sites / Locations

  • faculty of medicine, Aswan University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

No Intervention

Arm Label

NB-UVB radiation

Latanoprost

latanoprost + NB-UVB

healthy individuals

Arm Description

will expose to 2 sessions/week of NB-UVB radiation, for 3 months.

latanoprost 0.005%, will be applied after microneedling, by using 1.5-2 mm needle length dermapen, of vitiligenous patches. The procedure will be repeated once weekly for 3 months (12 sessions).

(latanoprost + NB-UVB group): latanoprost 0.005%, will be applied after microneedling of vitiligenous patches in the same day of NB-UVB sessions in the same manner of group 2.

healthy individuals as control group

Outcomes

Primary Outcome Measures

serum TWEAK in vitiligo
measurement of serum Tumor necrosis factor weak inducer of apoptosis (TWEAK)"pg/ml"; in vitiligo patients before and after treatment with NB-UVB, Latanoprost and their combination, all in comparison with healthy individuals, using ELISA (enzyme-linked immunosorbent assay)

Secondary Outcome Measures

treatment of vitiligo
clinical evaluation: Assessment of the disease severity in non-segmental vitiligo will be performed by using vitiligo area severity index (VASI score) before and after treatment with NB-UVB, latanoprost application applied after microneedling, by using 1.5-2 mm needle length dermapen, of vitiligenous patches, or combination of both of them. Patients will be photographed at baseline and after 3 months of regular treatment by using high resolution digital camera conon EOS 1300D 18 megapixels (made in Taiwan), photography will be done in standard light and distance.

Full Information

First Posted
March 7, 2021
Last Updated
August 7, 2023
Sponsor
Shaimaa Fawzy Abdel-rady Abdel-latif
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1. Study Identification

Unique Protocol Identification Number
NCT04811326
Brief Title
Latanoprost Plus NB-UVB Versus Each Alone in Non-segmental Vitiligo: Clinical and Laboratory Evaluation
Official Title
Latanoprost Plus NB-UVB Versus Each Alone in Non-segmental Vitiligo: Clinical and Laboratory Evaluation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 13, 2021 (Actual)
Primary Completion Date
February 13, 2024 (Anticipated)
Study Completion Date
March 13, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Shaimaa Fawzy Abdel-rady Abdel-latif

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The aim of the study is to evaluate the efficacy of different lines of therapies on the TWEAK serum level in patients with non-segmental vitiligo.
Detailed Description
the study is to evaluate the efficacy of NB-UVB, latanoprost, and combination of them on the TWEAK serum level in patients with non-segmental vitiligo.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-segmental Vitiligo

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NB-UVB radiation
Arm Type
Active Comparator
Arm Description
will expose to 2 sessions/week of NB-UVB radiation, for 3 months.
Arm Title
Latanoprost
Arm Type
Active Comparator
Arm Description
latanoprost 0.005%, will be applied after microneedling, by using 1.5-2 mm needle length dermapen, of vitiligenous patches. The procedure will be repeated once weekly for 3 months (12 sessions).
Arm Title
latanoprost + NB-UVB
Arm Type
Active Comparator
Arm Description
(latanoprost + NB-UVB group): latanoprost 0.005%, will be applied after microneedling of vitiligenous patches in the same day of NB-UVB sessions in the same manner of group 2.
Arm Title
healthy individuals
Arm Type
No Intervention
Arm Description
healthy individuals as control group
Intervention Type
Radiation
Intervention Name(s)
NB-UVB
Other Intervention Name(s)
narrow band ultraviolet B
Intervention Description
radiation
Intervention Type
Drug
Intervention Name(s)
Latanoprost
Other Intervention Name(s)
latanoprost eye drops
Intervention Description
eye drops
Primary Outcome Measure Information:
Title
serum TWEAK in vitiligo
Description
measurement of serum Tumor necrosis factor weak inducer of apoptosis (TWEAK)"pg/ml"; in vitiligo patients before and after treatment with NB-UVB, Latanoprost and their combination, all in comparison with healthy individuals, using ELISA (enzyme-linked immunosorbent assay)
Time Frame
3months
Secondary Outcome Measure Information:
Title
treatment of vitiligo
Description
clinical evaluation: Assessment of the disease severity in non-segmental vitiligo will be performed by using vitiligo area severity index (VASI score) before and after treatment with NB-UVB, latanoprost application applied after microneedling, by using 1.5-2 mm needle length dermapen, of vitiligenous patches, or combination of both of them. Patients will be photographed at baseline and after 3 months of regular treatment by using high resolution digital camera conon EOS 1300D 18 megapixels (made in Taiwan), photography will be done in standard light and distance.
Time Frame
3 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients with non-segmental vitiligo of any age and gender. Exclusion Criteria: History of vitiligo treatment with topical, systemic or biological agents prior to the study for at least 3 weeks. Pregnancy and lactation. Infections Patients with other autoimmune diseases. Patients with chronic diseases: cardiac diseases, hepatic disorders, hematologic disease, chronic renal failure or malignancies.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moustafa A El Taieb, prof.
Organizational Affiliation
Prof. and Head of Dermatology, Venereology and Andrology department, Aswan University, Egypt
Official's Role
Study Chair
Facility Information:
Facility Name
faculty of medicine, Aswan University
City
Aswan
State/Province
Aswan Governorate
ZIP/Postal Code
81528
Country
Egypt

12. IPD Sharing Statement

Learn more about this trial

Latanoprost Plus NB-UVB Versus Each Alone in Non-segmental Vitiligo: Clinical and Laboratory Evaluation

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