NCT03540966

Brief Summary

Vitiligo is a common depigmented skin disease characterized by destruction of functional melanocyte.The recent therapies to vitiligo are including oral or external glucocorticoids, antioxidants, calcineurin inhibitors or phototherapy. However, long treatment period and unsatisfactory curative effects still exist, which confer long-term psychological burden to patients. As above concerns, it is of great value to explore therapeutic methods that can effectively control disease, improve appearance, relieve patients' pain and improve their quality of life. Current problem is the lack of a vitiligo life quality evaluation scale with Chinese characteristics for us. Therefore, it is necessary for the investigator to compile a vitiligo quality of life scale that is simple, feasible and applicable to China's national conditions. Meanwhile the reliability analysis must be carried out to bring better quality of life assessment tools to patients with vitiligo in China. Previous studies recommended that CapulinTM showing a good cover effect on vitiligo, but the effects of camouflage on the QoL of patients with vitiligo in Chinese population is unknown. Thus, the investigators undergo a randomized open-label controlled study to estimate the effects of CapulinTM on QoL of patients with vitiligo.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2018

Completed
26 days until next milestone

First Posted

Study publicly available on registry

May 30, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

May 30, 2018

Status Verified

March 1, 2018

Enrollment Period

1 year

First QC Date

May 4, 2018

Last Update Submit

May 17, 2018

Conditions

Quality of Life

Outcome Measures

Primary Outcomes (1)

  • Chinese version of the vitiligo life quality index, VLQI-C

    Chinese version of the vitiligo life quality index, VLQI-C

    4 weeks

Secondary Outcomes (2)

  • VASI Scoring Criteria

    4 weeks

  • Vitiligo European Task Force assessment, VETFa

    4 weeks

Study Arms (2)

Group A

EXPERIMENTAL

complete Chinese version of the vitiligo life quality index, VLQI-C, conventional therapies plus CapulinTM on-demand treatment period

Combination Product: CapulinTMOther: Chinese version of the vitiligo life quality index, VLQI-C

Group B

PLACEBO COMPARATOR

complete Chinese version of the vitiligo life quality index, VLQI-C, conventional therapies on-demand treatment period

Other: Chinese version of the vitiligo life quality index, VLQI-C

Interventions

CapulinTMCOMBINATION_PRODUCT

a kind of camouflage agent

Group A
Chinese version of the vitiligo life quality index, VLQI-COTHER

a questionaire designed for patients with vitiligo

Group AGroup B

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects who signed Informed Consent Form；
  • Male or female subjects 18-64 years of age；
  • Clinically confirmed diagnosis of vitiligo as per the diagnostic criteria for vitiligo specified in Clinical Dermatology.

You may not qualify if:

  • Incompliance with the diagnosis of vitiligo.
  • Patients who had used other camouflage before;
  • Cannot read or understand questionnaire.
  • Patients who had taken antidepressants in the last three months had psychiatric and psycho-related illnesses.；
  • Inability to guarantee taking medications and completing visits as scheduled during the study;
  • 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；
  • Serious life-threatening condition such as cancer, autoimmune diseases；
  • Women of child-bearing potential who are pregnant, plan to become pregnant during study or are lactating；
  • Participating in other clinical studies or within 3 months;
  • Any other condition that the investigator deems unsuitable for entering the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, 710032, China

RECRUITING

Related Publications (1)

  • Chang Y, Zhang S, Zhang W, Li S, Li C. The Efficacy and Psychoneuroimmunology Mechanism of Camouflage Combined With Psychotherapy in Vitiligo Treatment. Front Med (Lausanne). 2022 May 27;9:818543. doi: 10.3389/fmed.2022.818543. eCollection 2022.

    PMID: 35721084DERIVED

Study Officials

  • Chunying Li

    Principal Investigator

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuqian Chang

CONTACT

+86 18165312307330969786@qq.com

Shaolong Zhang

CONTACT

+86 13319189530499568152@qq.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2018

First Posted

May 30, 2018

Study Start

January 1, 2018

Primary Completion

January 1, 2019

Study Completion

January 1, 2020

Last Updated

May 30, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)