A comparative study of a combined treatment with fractional carbon dioxide, 0.01% Bimatoprost and narrowband ultraviolet B phototherapy versus a combined treatment with fractional carbon dioxide and narrowband ultraviolet B phototherapy in non-segmental vitiligo: A randomized controlled trial

Phase 2

• Conditions: SunburnInfectionhypertrophic scar or keloidAllergic contact dermatitisHypertrichosis; Vitiligo; Bimatoprost; Fractional Co2 laser; Narrow band ultraviolet B

• Registration Number: TCTR20200923001
• Lead Sponsor: Srinakharinwirot university

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-23
• Study Completion: 2022-07-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

1.Patient older than 18 years old.
2.Patient with non-segmental vitiligo which bilateral symmetry and there are 2 more lesions.
3.Lesions stable for at least 1 year.
4.There is no serious underlying disease.
5.Patients are 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

1. The vitiligo was treated by other treatments within 4 weeks prior attend.
2. History of photosensitivity or disease exacerbated by sun light.
3. History of easily to hypertrophic scar occurs.
4. Patients with sensitivity to bimatoprost such as allergy or asthma.
5. Pregnancy or lactation.
6. Deny or withdraw during attending the project.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate total surface area of lesions 4 months (before treatment, 2nd, 4th, 8th, 12th, 16th) The lesions were taken a photo by digital camera and measured by photoshop program (Adobe photoshop)

Secondary Outcome Measures

Name	Time	Method
Evaluate melanin average level and melanin variation 4 months (before treatment, 2nd, 4th, 8th, 12th, 16th) The lesions were measured a melanin average level and melanin variation by Antera 3D camera.,Repigmentation of skin lesions 4 months The lesions will be compared with a photo by digital camera at 2nd ,4th, 8th, 12th and 16th week,Assess the pattern of repigmentation 4 months Assess the lesion by digital camera at 12th and 16th week. ,Assess side effects and frequent of treatment 4 months A note book will be provided to patients for recording the side effects of treatment .,Assess recurrent rate of disease 4 months Dermatologist will compare the lesion between end of treatment (week 12) and week 16 of treatment.,Assess satisfied of treatment 4 months visual analogue scale (VAS) will be assessed at 12th and 16th week.