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

NCT ID: NCT04811326

Last Updated: 2023-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-13

Study Completion Date

2024-03-13

Brief Summary

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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

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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.

Conditions

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Non-segmental Vitiligo

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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NB-UVB radiation

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

Group Type ACTIVE_COMPARATOR

NB-UVB

Intervention Type RADIATION

radiation

Latanoprost

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).

Group Type ACTIVE_COMPARATOR

Latanoprost

Intervention Type DRUG

eye drops

latanoprost + NB-UVB

(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.

Group Type ACTIVE_COMPARATOR

NB-UVB

Intervention Type RADIATION

radiation

Latanoprost

Intervention Type DRUG

eye drops

healthy individuals

healthy individuals as control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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NB-UVB

radiation

Intervention Type RADIATION

Latanoprost

eye drops

Intervention Type DRUG

Other Intervention Names

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narrow band ultraviolet B latanoprost eye drops

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shaimaa Fawzy Abdel-rady Abdel-latif

OTHER

Sponsor Role lead

Responsible Party

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Shaimaa Fawzy Abdel-rady Abdel-latif

investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Moustafa A El Taieb, prof.

Role: STUDY_CHAIR

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

Locations

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faculty of medicine, Aswan University

Aswān, Aswan Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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504/1/21

Identifier Type: -

Identifier Source: org_study_id

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