Effects of Combination Therapy With Camouflage in the Repigmentation of Vitiligo

Vitiligo Clinical Trial

Official title:

Evaluation of the Potential Interference of Camouflage on the Treatment of Vitiligo: an Observer-blinded Self-controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03973073
• Other study ID #: 2019PHB002-01
• Status: Completed
• Phase: Phase 1
• Start date: August 1, 2019
• Est. completion date: November 21, 2019

Study information

• Verified date: July 2020
• Source: Peking University People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 21, 2019
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Vitiligo

Intervention

Combination Product:
• CapulinTM
camouflage

Other:
• topical applications and NB-UVB
combination therapy of vitiligo

Locations

Country	Name	City	State
China	Peking university people's hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	types of regimentation types	The types of repigmentation patterns were classified as perifollicular, marginal, diffuse and mixed configuration.	12 weeks
Secondary	Transepidermal water loss	TEWL at baseline and 12-week's follow-up between 2 groups	12 weeks
Secondary	Adverse events	allergic reactions, edema, erythema, pruritis	12 weeks