Effects of Combination Therapy With Camouflage in the Repigmentation of Vitiligo

NCT ID: NCT03973073

Last Updated: 2020-07-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-01
• Study Completion Date: 2019-11-21

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.

Detailed Description

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, especially when the exposed skin are involved, such as face and extremities.

The pathogenesis of vitiligo is not clear yet. The most common methods of treatment include systemic corticosteroids, topical application (such as corticosteroids, calcineurin inhibitors), phototherapy, traditional medications and so on. In view of the difficulty of vitiligo treatment, the combination therapy between drugs and phototherapy 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.

For patients seeking to mask their vitiligo, camouflage options have historically been limited and been designated as a cosmetic, rather than a medical concern. As research has indicated that proper concealment of vitiligo lesions can vastly improve quality of life, we believe it is essential that dermatologists become aware of all the options available to their patients and that discussions of camouflage options be broached from the first visit. Until now, 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 CapulinTM is dihydroxyacetone, and it also contains natural plant extracts, moisturizers, emollients and natural pigments. The repigmented mechanism is to combine with the keratin and to form a special brown polymer, which makes leukoderma close to normal skin.

Although the guidelines of home and abroad consider camouflage as the fundamental treatment of vitiligo, 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 observer-blinded 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

camouflage group

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

Group Type: EXPERIMENTAL

CapulinTM

Intervention Type: COMBINATION_PRODUCT

camouflage

topical applications and NB-UVB

Intervention Type: OTHER

combination therapy of vitiligo

blank group

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

Group Type: OTHER

topical applications and NB-UVB

Intervention Type: OTHER

combination therapy of vitiligo

Interventions

CapulinTM

camouflage

Intervention Type: COMBINATION_PRODUCT

topical applications and NB-UVB

combination therapy of vitiligo

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

dujuan

chief physician of dermatology, Principal investigator, clinical professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Juan Du, Doctor

Role: PRINCIPAL_INVESTIGATOR

Peking University People's Hospital

Locations

Peking university people's hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

2019PHB002-01

Identifier Type: -

Identifier Source: org_study_id