Effects of Combination Therapy With Camouflage in the Repigmentation of Vitiligo

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

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.

Study Overview

• Status: Completed
• Conditions: Vitiligo
• Intervention / Treatment: Combination product: CapulinTM; Other: topical applications and NB-UVB

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100044
      • Peking University People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 70 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: camouflage group; Topical applications and/or NB-UVB plus Capulin TM on-demand treatment period	Combination product: CapulinTM; camouflage; Other: topical applications and NB-UVB; combination therapy of vitiligo
OTHER: blank group; Topical applications and/or NB-UVB on-demand treatment	Other: topical applications and NB-UVB; combination therapy of vitiligo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Peking University People's Hospital
• Investigators: Principal Investigator: Juan Du, Doctor, Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2019
• Primary Completion (ACTUAL): November 1, 2019
• Study Completion (ACTUAL): November 21, 2019

Study Registration Dates

• First Submitted: June 2, 2019
• First Submitted That Met QC Criteria: June 2, 2019
• First Posted (ACTUAL): June 4, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 7, 2020
• Last Update Submitted That Met QC Criteria: July 4, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pigmentation Disorders; Hypopigmentation; Vitiligo
• Other Study ID Numbers: 2019PHB002-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No