Effects of Combination Therapy With Camouflage in the Repigmentation of Vitiligo

NCT03973073 | Completed Phase 1

• 1 other identifier: 2019PHB002-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Vitiligo is a common depigmented skin disorder characterized by the white patches of skin and mucous membrane. It can be cosmetically disfiguring and lead to serious psychological problems for patients with vitiligo. In view of the difficulty of vitiligo treatment, the combination therapy is the most recommended. Despite that, the process of repigmentation usually last for several months to several years. So it is of great value to explore therapeutic methods that can improve appearance, relieve patients' pain and improve their quality of life in the process of treatment. The use of camouflage can vastly improve quality of life, both the European and Japanese guidelines of vitiligo management recommend that once vitiligo is diagnosed, camouflage should be used. The first commercial camouflage agent in China is CapulinTM by 2004. The main component of it is dihydroxyacetone. The repigmented mechanism is to combine with the keratin and to form a special brown polymer, which makes leukoderma close to normal skin. While, it is unknown whether camouflage has an impact on the drug absorption, efficiency of phototherapy and thus influences the repigmentation of vitiligo. Thus, the investigators undergo a randomized open-label self-controlled study to estimate the effects of combination therapy between camouflage and topical application and/or NB-UVB in the repigmentation of vitiligo.

Conditions

Vitiligo

Outcome Measures

Primary Outcomes (1)

• Repigmentation area of vitiligo

  The primary endpoint was percentage of repigmentation, assessed using photographs taken at baseline and each follow up visit. The photographs were shown to three dermatologists (blinded observers) for independent assessment and a mean of these values was taken.

  12 weeks

Secondary Outcomes (3)

• types of regimentation types

  12 weeks

• Transepidermal water loss

  12 weeks

• Adverse events

  12 weeks

Study Arms (2)

camouflage group

EXPERIMENTAL

Topical applications and/or NB-UVB plus Capulin TM on-demand treatment period

Combination Product: CapulinTM; Other: topical applications and NB-UVB

blank group

OTHER

Topical applications and/or NB-UVB on-demand treatment

Other: topical applications and NB-UVB

Interventions

CapulinTM COMBINATION_PRODUCT

camouflage

camouflage group

topical applications and NB-UVB OTHER

combination therapy of vitiligo

blank group; camouflage group

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who signed Informed Consent Form；
• Male or female subjects 16 years of age or older；
• Clinically confirmed diagnosis of vitiligo；
• Existing 2 symmetrical or adjacent white patches with similar size or a single lesion area greater than 5 cm2

You may not qualify if:

• Tend to automatically repigment；
• Allergic history of any relevant ingredient in the camouflage;
• The combination of eczema, contact dermatitis, urticaria and other allergic diseases or other serious diseases which are not suitable for the treatment of skin diseases；
• Women of child-bearing potential who are pregnant, plan to become pregnant during study or are lactating；
• Any other condition that the investigator deems unsuitable for entering the study.

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking university people's hospital

Beijing, Beijing Municipality, 100044, China

Location

MeSH Terms

Conditions

Vitiligo

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Juan Du, Doctor

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician of dermatology, Principal investigator, clinical professor

Study Record Dates

• First Submitted: June 2, 2019
• First Posted: June 4, 2019
• Study Start: August 1, 2019
• Primary Completion: November 1, 2019
• Study Completion: November 21, 2019
• Last Updated: July 7, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)