Quality of LifeEarly Phase 1NCT03540966
Effects of Camouflage on the Life Quality of Patients With Vitiligo
A Early Phase 1 study testing CapulinTM and Chinese version of the vitiligo life quality index, VLQI-C in people with Quality of Life, run by Xijing Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Quality of Life
- What is being tested?
- CapulinTM and Chinese version of the vitiligo life quality index, VLQI-C
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to Jan 2020
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xijing Hospital
Xi'an, Shaanxi, 710032
Yuqian Chang, +86 18165312307, 330969786@qq.com
About this study
Official title: Development and Psychometric Validation of the Chinese Version of Vitiligo Life Quality Index and Effects of Camouflage on the Life Quality of Patients With Vitiligo: A Randomized Open-label Controlled Study
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.
Read the detailed description
Vitiligo is a common depigmented skin disease characterized by destruction of functional melanocyte. The global incidence is about 0.5-2.0% and prevalence be about 0.8-1.5% in China. Studies showed that almost half of vitiligo patients had developed depigmentation before 20 years old. Lesions involving exposed skin such as face, hand or mucous always make patients feeling embarrassment, so the impaired quality of life (QoL) have greater impact on patients with vitiligo than the disease itself. Besides, Vitiligo is also a psychosomatic disease as its cause stress or depression which can induce dysfunction of endocrine system or immune system in patients, finally resulted in poor curative effects and relapse of the disease which further aggravates stress and depression in patients. Furthermore, traditional Chinese medicine suggested that uneasiness would be a cause of vitiligo as well.
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. Dermatologists of Japan and European suggested that camouflage would be a proper way to improve patients' appearance and it should be an effective supplement to the treatments of vitiligo.
With the transformation of the medical model from a simple biomedical model to a bio-psychological-social medical model, observing changes of lesion in vitiligo may not fully reflect the impact of vitiligo on patients. Therefore, it is necessary to develop some evaluation methods to reflect the impact of vitiligo in patients. Among the various measurement tools, universality scales have a wide range of measurement and can be applied to different groups of people to understand the general health status of the general population. But there are some limitations due to the unspecifically designed for a disease group. When the universal scale is applied to a specific disease, it does not have specificity. Some clinically significant information on quality of life may be omitted, and the QOL cannot be sensitively reflected. The scales in the dermatology area were developed for patients with dermatological diseases and reflect the differences between skin diseases and other system diseases. However, the specificity and sensitivity of specific diseases are still not strong enough.The 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.
Camouflage is an emerging solution to improve patients' appearance which showing a great potential in treatment of vitiligo. Diagnosis and treatment of vitiligo consensus (2014 edition) made by the dermatological department of the Chinese medical association also suggest that camouflage can be used on exposed skin such as face, neck, hands or feet.The first commercial camouflage agent in China is CapulinTM by 2004, Its formula contains natural plant extracts, moisturizers, emollients and natural pigments. The regimented mechanism is to combine the camouflage with the free protein on the cuticle and finally format the mimic human natural melanin, which is extremely similar to normal skin tone. 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.
- Conditions
- Quality of Life
- Being tested
- CapulinTM, Chinese version of the vitiligo life quality index, VLQI-C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapulinTMCombination product
a kind of camouflage agent
Chinese version of the vitiligo life quality index, VLQI-COther
a questionaire designed for patients with vitiligo
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | complete Chinese version of the vitiligo life quality index, VLQI-C, conventional therapies plus CapulinTM on-demand treatment period Receives: Combination Product: CapulinTM; Other: 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 Receives: Other: Chinese version of the vitiligo life quality index, VLQI-C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chinese version of the vitiligo life quality index, VLQI-C
Chinese version of the vitiligo life quality index, VLQI-C
Measured: 4 weeks
Secondary outcomes (2)
VASI Scoring Criteria
VASI=Σall body sites (hand units) × depigmentation
Measured: 4 weeks
Vitiligo European Task Force assessment, VETFa
Vitiligo European Task Force assessment, VETFa
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2018
- Study start1 Jan 2018
- Primary completionJan 2019 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chunying Li, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03540966
- Sponsor's protocol ID
- XJPF-LCY-V201804
- Status last verified
- Mar 2018
- First submitted
- 4 May 2018
- Last updated
- 30 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35721084
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Psychometric Validation of the Chinese Version of Vitiligo Life Quality Index and Effects of Camouflage on the Life Quality of Patients With Vitiligo: A Randomized Open-label Controlled Study
- ClinicalTrials.gov ID
- NCT03540966
- Acronym / sponsor ID
- XJPF-LCY-V201804
- Conditions
- Quality of Life
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 30 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Vitiligo is a common depigmented skin disease characterized by destruction of functional melanocyte. The global incidence is about 0.5-2.0% and prevalence be about 0.8-1.5% in China. Studies showed that almost half of vitiligo patients had developed depigmentation before 20 years old. Lesions involving exposed skin such as face, hand or mucous always make patients feeling embarrassment, so the impaired quality of life (QoL) have greater impact on patients with vitiligo than the disease itself. Besides, Vitiligo is also a psychosomatic disease as its cause stress or depression which can induce dysfunction of endocrine system or immune system in patients, finally resulted in poor curative effects and relapse of the disease which further aggravates stress and depression in patients. Furthermore, traditional Chinese medicine suggested that uneasiness would be a cause of vitiligo as well.
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. Dermatologists of Japan and European suggested that camouflage would be a proper way to improve patients' appearance and it should be an effective supplement to the treatments of vitiligo.
With the transformation of the medical model from a simple biomedical model to a bio-psychological-social medical model, observing changes of lesion in vitiligo may not fully reflect the impact of vitiligo on patients. Therefore, it is necessary to develop some evaluation methods to reflect the impact of vitiligo in patients. Among the various measurement tools, universality scales have a wide range of measurement and can be applied to different groups of people to understand the general health status of the general population. But there are some limitations due to the unspecifically designed for a disease group. When the universal scale is applied to a specific disease, it does not have specificity. Some clinically significant information on quality of life may be omitted, and the QOL cannot be sensitively reflected. The scales in the dermatology area were developed for patients with dermatological diseases and reflect the differences between skin diseases and other system diseases. However, the specificity and sensitivity of specific diseases are still not strong enough.The 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.
Camouflage is an emerging solution to improve patients' appearance which showing a great potential in treatment of vitiligo. Diagnosis and treatment of vitiligo consensus (2014 edition) made by the dermatological department of the Chinese medical association also suggest that camouflage can be used on exposed skin such as face, neck, hands or feet.The first commercial camouflage agent in China is CapulinTM by 2004, Its formula contains natural plant extracts, moisturizers, emollients and natural pigments. The regimented mechanism is to combine the camouflage with the free protein on the cuticle and finally format the mimic human natural melanin, which is extremely similar to normal skin tone. 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Combination Product: CapulinTM, Other: Chinese version of the vitiligo life quality index, VLQI-Ccomplete Chinese version of the vitiligo life quality index, VLQI-C, conventional therapies plus CapulinTM on-demand treatment period |
| Group B | Placebo comparator | Other: Chinese version of the vitiligo life quality index, VLQI-Ccomplete Chinese version of the vitiligo life quality index, VLQI-C, conventional therapies on-demand treatment period |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CapulinTMa kind of camouflage agent | Combination product | Group A |
| Chinese version of the vitiligo life quality index, VLQI-Ca questionaire designed for patients with vitiligo | Other | Group A, Group B |
Primary outcome
Chinese version of the vitiligo life quality index, VLQI-C
Time frame: 4 weeks
Chinese version of the vitiligo life quality index, VLQI-C
2 secondary outcomes
VASI Scoring Criteria
Time frame: 4 weeks
Vitiligo European Task Force assessment, VETFa
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2018.
- Derived from this study: PubMed 35721084Chang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chunying Li principal investigator
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing CapulinTM and Chinese version of the vitiligo life quality index, VLQI-C in people with Quality of Life, run by Xijing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuqian Chang (+86 18165312307, 330969786@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chinese version of the vitiligo life quality index, VLQI-C (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03540966, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2018.