Effects of Combination Therapy With Camouflage in the Repigmentation of Vitiligo
Condition: Vitiligo
MeSH terms: Vitiligo
Study type: Interventional
Phase: Phase 1

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.
    

Intervention name(s): CapulinTM; topical applications and NB-UVB
Intervention type(s): Combination Product; Other
Intervention description(s): camouflage; combination therapy of vitiligo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care