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

NCT04811326 | Unknown Phase 4

• 1 other identifier: 504/1/21
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-segmental Vitiligo

Outcome Measures

Primary Outcomes (1)

• 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)

  3months

Secondary Outcomes (1)

• treatment of vitiligo

  3 months

Study Arms (4)

NB-UVB radiation

ACTIVE COMPARATOR

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

Radiation: NB-UVB

Latanoprost

ACTIVE COMPARATOR

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).

Drug: Latanoprost

latanoprost + NB-UVB

ACTIVE COMPARATOR

(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.

Radiation: NB-UVB; Drug: Latanoprost

healthy individuals

NO INTERVENTION

healthy individuals as control group

Interventions

NB-UVB RADIATION

radiation

Also known as: narrow band ultraviolet B

NB-UVB radiation; latanoprost + NB-UVB

Latanoprost DRUG

eye drops

Also known as: latanoprost eye drops

Latanoprost; latanoprost + NB-UVB

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shaimaa Fawzy Abdel-rady Abdel-latif: lead

Study Sites (1)

faculty of medicine, Aswan University

Aswān, Aswan Governorate, 81528, Egypt

Location

MeSH Terms

Interventions

Latanoprost

Intervention Hierarchy (Ancestors)

Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Moustafa A El Taieb, prof.

  Prof. and Head of Dermatology, Venereology and Andrology department, Aswan University, Egypt

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: investigator

Study Record Dates

• First Submitted: March 7, 2021
• First Posted: March 23, 2021
• Study Start: January 13, 2021
• Primary Completion: February 13, 2024
• Study Completion: March 13, 2024
• Last Updated: August 9, 2023

Record last verified: 2023-08

Locations

EG (1)