Efficacy and Tolerance of the Cosmetic Care Product RV5098A on the Maintenance of Pigmentation on Face in Adult Patients With Vitiligo.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Efficacy of the test product RV5098A on the maintenance of pigmentation by the global evolution of facial vitiligo
研究概览
简要总结
Vitiligo is an autoimmune depigmentation disorder affecting 0.5 to 1% of the population worldwide. Vitiligo lesions are characterized by a progressive loss of pigmentation caused by the disappearance of functioning melanocytes in the epidermis, mainly resulting from the activation of immune cells in a genetically predisposed patient.
Despite major advances in the understanding of the mechanisms of the disease, the treatment remains challenging. Different treatment strategies could lead to cosmetically acceptable repigmentation (>75%), particularly on face and neck. However, after repigmentation, the risk of relapse is estimated at nearly 40% during the first year after stopping treatment.
To date, long-term management remains a challenge. With their topical product RV5098A adapted for patients with vitiligo, Pierre Fabre Laboratories hypothesize that it could be effective in maintaining pigmentation of previously repigmented lesions in adults with facial vitiligo.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Criteria related to the population:
- •- Subject aged between 18 and 75 years included.
- •Criteria related to the disease:
- •Subject with facial vitiligo, regardless of its duration.
- •having a sufficient repigmentation rate of the vitiligo after repigmenting treatment
- •Criteria related to treatments and/or products:
- •- Subject responder to a repigmenting treatment
- •Non-inclusion Criteria:
- •Criteria related to the diseases / skin condition:
- •Subject with active vitiligo.
- •Subject with spontaneous repigmentation without treatment.
- •Subject having other dermatological condition, an acute, chronic, or progressive disease or history of disease liable to interfere with the study assessments or considered by the Investigator hazardous for the subject or incompatible with the study requirements.
- •Criteria related to treatments and/or products:
- •Systemic immunomodulatory treatment taken for another pathology, before inclusion, on-going or planned to be established during the study.
- •Any topical immunomodulatory treatment applied on the face for another pathology, on-going or planned to be established during the study.
- •Any other topical or systemic treatment established or modified during the previous weeks or planned to be established or modified during the study, liable to interfere with the evaluation of the efficacy according to the investigator's assessment.
- •Any dietary supplement for vitiligo within 4 weeks before the inclusion visit or planned to be established during the study.
排除标准
- 未提供
结局指标
主要结局
Efficacy of the test product RV5098A on the maintenance of pigmentation by the global evolution of facial vitiligo
时间窗: assessed after 24 weeks of use
assessed by the investigator on the face on a 7-point scale (from significant worsening to significant improvement)
次要结局
- Efficacy of the test product RV5098A on the maintenance of pigmentation by the global evolution of facial vitiligo assessed by the investigator(assessed after 12 weeks of use)
- Efficacy of the test product RV5098A on the maintenance of pigmentation by the global evolution of facial vitiligo assessed by the subject(assessed after 12 and 24 weeks of use and monthly at home)
- Efficacy of the test product RV5098A on the maintenance of pigmentation by the severity of facial vitiligo by the investigator(assessed at baseline and after 12 and 24 weeks of use.)
- Efficacy of the test product RV5098A on the maintenance of pigmentation by the severity of facial vitiligo by the subject(assessed at baseline, after 12 and 24 weeks of use and monthly at home)
- Efficacy of the test product RV5098A on the maintenance of pigmentation by the impact on quality of life assessed by the patient(assessed at baseline, after 12 and 24 weeks of use)
- Efficacy of the test product RV5098A on the maintenance of pigmentation by imaging quantification.(assessed at baseline, after 12 and 24 weeks of use.)
- Efficacy of the test product RV5098A on the maintenance of pigmentation by the extent of facial vitiligo(assessed at baseline and after 12 and 24 weeks of use.)
- Cosmetic satisfaction and perceived effects as regards to the use of the test product RV5098A by Cosmetic acceptability questionnaire assessed by the patient(assessed after 12 and 24 weeks of use.)
- Global tolerance of the test product RV5098A assessed by the investigator.(assessed after 24 weeks of use.)
- Compliance of the subjects to the test product RV5098A(through study completion, 6 months)