跳至主要内容
临床试验/NCT06841393
NCT06841393终止不适用

Knowledge and Exploratory Study to Better Understand Face Acne Pathophysiology and Acne Lesion Severity by Multi-omic Approaches, Biometrological Analysis and Consumer Needs

Pierre Fabre Dermo Cosmetique2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年10月16日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
50
试验地点
2
主要终点
Cutaneous pH measurement

研究概览

简要总结

Acne vulgaris (acne) is a chronic inflammatory pathology of the pilosebaceous unit. Its prevalence is about 85% of teenagers and is constantly increasing in adults, especially women. Acne is a multifactorial disease involving abnormalities in follicular keratinization, sebum production, skin microbiota and inflammation.

The early stage of acne is characterized by the presence of primary retentional lesions: the open comedones (or blackheads) and closed comedones (or whitehead). These retentional lesions can progress to highly inflammatory lesions: superficial inflammatory lesions (papules and pustules) and in some cases in deep inflammatory lesions (nodules). Finally, acne lesions can lead to the development of superficial post inflammatory erythema or hyperpigmentation, resulting in emotional distress and a poorer quality of life.

Currently, a better understanding of the switch from healthy to acne-prone skin, but also of the transition from retentional lesions to more severe inflammatory lesions, seems essential to propose adapted and specific treatments.

The aim of this study is to better understand acne pathophysiology of the face by a multi-omic approaches, biometrological analysis and consumer needs collection to bring information, in the same study on the local ecosystem of non-lesional areas, retentional lesional areas and inflammatory lesional areas of adult acne prone skin, compared to acne free face.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Criteria related to the population:
  • For women of childbearing potential: pregnant or breastfeeding
  • Subject having received on face artificial UV exposure, excessive or prolonged exposure to natural sunlight within 4 weeks before the inclusion visit
  • Subject with facial hair liable to interfere with the study assessments
  • Criteria related to the disease:
  • Clinical signs of hormone dysfunction or hyperandrogenism
  • Severe form of acne (acne conglobata, acne fulminans or nodulocystic acne) or acneiform eruptions, in the investigator's opinion
  • Sunburn on the face due to excessive UV exposure
  • Criteria related to skin condition:
  • Subject having any other dermatologic condition than acne, or characteristics (like tattoo) on the face liable to interfere with the study assessments
  • Specific for control group:
  • Subject with significant acne lesions according to investigator assessment
  • Subject having any inflammatory face dermatosis
  • Criteria related to treatments and/or products:
  • Any surgery, chemical or physical treatment on the face in the 12 months before the inclusion visit
  • Systemic isotretinoin treatment taken in the 6 months prior before the inclusion visit
  • Systemic acne treatment taken in the 3 months before the inclusion visit
  • Probiotics taken orally in the month before the inclusion visit
  • Topical acne treatment applied to the face in the month before the inclusion visit
  • Topical or Systemic Non-Steroidal Anti-Inflammatory (NSAI), corticosteroids, taken or applied to the face in the 2 weeks before the inclusion visit
  • Skincare product for acne liable to interfere with the study according to investigator's assessment applied to the face in the 2 weeks before the inclusion visit

排除标准

  • 未提供

结局指标

主要结局

Cutaneous pH measurement

时间窗: baseline (Visit 1- Day 1)

by pH - pHmeter

Sebum quantification

时间窗: baseline (Visit 1- Day 1)

by Lipidic Index (LI) - Sebumeter®

Epigenetic analysis by sampling method (urine)

时间窗: baseline (Visit 1- Day 1)

Lipidomic profile by sampling method (scotch)

时间窗: baseline (Visit 1- Day 1)

By lipidomic analysis

Consumers' perception

时间窗: baseline (Visit 1- Day 1)

by a questionnaire about acne skin, skincare routine, needs and expectations in terms of facial care in acne group

Cutaneous barrier integrity

时间窗: baseline (Visit 1- Day 1)

by Trans-Epidermal Water Loss (TEWL) - Aquaflux®

Microbiota profile by sampling method (extracted comedones)

时间窗: baseline (Visit 1- Day 1)

for acne group only

Microbiota profile by sampling method (swabs)

时间窗: baseline (Visit 1- Day 1)

By non-targeting metagenomics

Metabolomic profile by sampling method (extracted comedones)

时间窗: baseline (Visit 1- Day 1)

for acne group only

Lipidomic profile by mass spectroscopy (in-vivo measurements)

时间窗: baseline (Visit 1- Day 1)

Each characteristic peak corresponding to specific lipid will be quantified by its mass intensity

Metabolomic profile by sampling method (swabs)

时间窗: baseline (Visit 1- Day 1)

By metabolomic analysis

Acne severity on the face

时间窗: baseline (Visit 1- Day 1)

using Global Acne Evaluation (GEA) scale on a 6-point scale (0, 1, 2, 3, 4, 5 with 0 = clear - no lesions and 5 = very severe) in acne group only

Lipidomic profile by sampling method (extracted comedones)

时间窗: baseline (Visit 1- Day 1)

for acne group only

Lesions quantification

时间窗: baseline (Visit 1- Day 1)

by the number of inflammatory lesions (papules and/or pustules) in acne group

次要结局

未报告次要终点

研究者

发起方
Pierre Fabre Dermo Cosmetique
申办方类型
Industry
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

Assessment of Biological, Biometrological Parameters... | 临床试验