A Phase 1 interventional study of CapulinTM and topical applications and NB-UVB in Vitiligo, sponsored by Peking University People's Hospital. Completed at 1 site in China. Open to participants aged 16 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-07-07.
Sponsored by Peking University People's Hospital · Phase 1, Interventional, and Supportive care
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.
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.
298 studies on the registry are indexed under Vitiligo; 69 are open to participants now.
This study's enrollment of 30 is close to the median of 30 across 227 interventional studies indexed under Vitiligo.
Browse Vitiligo studies →Peking University People's Hospital is the lead sponsor of 584 studies on the registry; 233 are open to participants now.
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Exclusion Criteria:
Topical applications and/or NB-UVB plus Capulin TM on-demand treatment period
Combination Product: CapulinTM · Other: topical applications and NB-UVB
Topical applications and/or NB-UVB on-demand treatment
Other: topical applications and NB-UVB
camouflage
combination therapy of vitiligo
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.
Time frame: 12 weeks
types of regimentation types
The types of repigmentation patterns were classified as perifollicular, marginal, diffuse and mixed configuration.
Time frame: 12 weeks
Transepidermal water loss
TEWL at baseline and 12-week's follow-up between 2 groups
Time frame: 12 weeks
Adverse events
allergic reactions, edema, erythema, pruritis
Time frame: 12 weeks
Plan to share: No
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Peking University People's Hospital