A Comparative study of efficacy and safety of combination treatment with oral minocycline and narrowband UV-B phototherapy versus narrowband UV-B alone in generalized vitiligo

Phase 2

Recruiting

• Conditions: generalized vitiligo; vitiligo; minocycline; Phototherapy

• Registration Number: TCTR20210311002
• Lead Sponsor: Srinakharinwirot University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-11
• Study Completion: 2021-07-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

Subject (man or woman) is older than 18 years old
Subject with generalized vitiligo with a body surface area involved >10%
Subject is able to recieve phototherapy treatment twice a week for 12 weeks
subject is willing to participate in research project with sign the inform consent before attend the study and can be responsible to treatment along total course.

Exclusion Criteria

subject has recieved in the 3 month prior to enrolment the following therapies; phototherapy, any immunomodulator, systemic corticosteroids and any antioxidants.
subject has recieved the topical treatment (topical corticosteroids, topical vitaminD) within 2 weeks of enrolment.
subject has a history of radiotherapy, chemotherapy or immunosuppressive therapy
subject has a history of skin cancer,photosensitivity or photomediatied disorders and claustrophobia
subject has been diagnosed as renal failure or liver disease.
subject has an abnormal liver enzyme test (AST,ALT) ,eGFR<60mg/ml and ANA titer more than 1:160
sudject has a history of allergy to tetracyclines.
subject is pregnant(as determined by LMP)or subject is breastfeeding.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the depigmentation and repigmentation of vitiligo Baseline, at the end of 4th, 8th and 12th weeks VItiligo Area Scoring Index score

Secondary Outcome Measures

Name	Time	Method
the repigmenation Baseline, at the end of 4th, 8th and 12th weeks Quartile grading scales,disease activity Baseline, at the end of 4th, 8th and 12th weeks Vitiligo Disease Activity Index ,Patient satisfaction Baseline, at the end of 12th weeks Visual analog scales,Quality of life Baseline, at the end of 12th weeks Dermatology Life Quality Index