A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Tripalmitoleoylglycerol for the Treatment of Dermatitis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- 1. Mean change in transepidermal water loss (TEWL, g/h/m²) from baseline to Day 7 at the intervention site
研究概览
简要总结
This randomized, double-blind, placebo-controlled clinical trial is designed to evaluate the safety and efficacy of topical palmitoleic acid glyceride supplementation in improving skin barrier impairment associated with chronic dermatitis, with a particular focus on the interaction between physical activity, skin microbiota, and lipid metabolism.
Emerging evidence suggests that regular physical activity reshapes the skin microenvironment, including alterations in sebaceous lipid composition and enrichment of Staphylococcus epidermidis, which possesses lipase activity capable of metabolizing glycerides into bioactive fatty acids. Palmitoleic acid, a key lipid metabolite derived from palmitoleic acid glycerides, has demonstrated anti-inflammatory and barrier-protective properties in preclinical and clinical settings. However, it remains unclear whether restoring exercise-associated lipid metabolites through topical application can improve skin barrier dysfunction in individuals with chronic dermatitis, and whether physical activity status modifies therapeutic efficacy.
Research Objectives：
- Does topical application of low-concentration palmitoleic acid glyceride improve skin barrier function, as measured by transepidermal water loss (TEWL), in individuals with chronic dermatitis?
- Does physical activity status influence the therapeutic response to palmitoleic acid glyceride treatment?
- Are improvements in skin barrier function associated with changes in skin microbiota composition, microbial lipase activity, and lipid metabolism at the skin surface?
Study Design and Group Allocation：
Eligible male/female participants aged 18-59 years with clinical manifestations of chronic dermatitis and evidence of skin barrier impairment will be enrolled. Based on metabolic equivalents (MET) levels outside of daily living activities, participants will be divided into sedentary group and exercise group. Within each stratum, participants will be randomly assigned in a 1:1 ratio to receive either topical palmitoleic acid glyceride or placebo, resulting in four study groups:
- Inactive Placebo Group: No regular physical activity; topical placebo.
- Inactive Intervention Group: No regular physical activity; topical tripalmitoleoylglycerol.
- Active Placebo Group: Regular physical activity; topical placebo.
- Active Intervention Group: Regular physical activity; topical tripalmitoleoylglycerol.
Participant Procedures：
- Daily topical application of either 0.5% tripalmitoleoylglycerol or placebo to a predefined skin lesion area for 30 consecutive days.
- Non-invasive assessment of skin barrier function, including TEWL measurements, at baseline and after completion of the intervention.
- Clinical evaluation of skin symptoms, including erythema, scaling, and pruritus, using standardized scoring systems (PASI or SCORAD, as appropriate).
- Collection of skin swab samples for microbiome and metabolomic analyses to assess microbial lipase activity and palmitoleic acid production.
- Weekly follow-up assessments to monitor treatment adherence and record any adverse events, particularly local skin reactions.
This study seeks to elucidate a novel exercise-microbiota-lipid axis in skin barrier regulation and to provide translational evidence for metabolite-based therapeutic strategies in chronic inflammatory skin diseases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants were classified into two groups based on their self-reported levels of physical activity (quantified in metabolic equivalent minutes per week [MET-min/week]): the non-exercising group (MET = 0): individuals who reported no moderate- or vigorous-intensity physical activity beyond activities of daily living. In this context, a value of 0 MET-min/week indicates that no structured or intentional exercise exceeding the threshold of basal metabolic rate was performed. Exercise group (MET > 0): This group includes any individual who engages in at least some level of physical activity, with a calculated MET-min/week value greater than
- •Presence of clinical manifestations of skin barrier impairment, such as skin dryness, erythema, scaling, or pruritus;
- •Voluntary participation with full understanding of the study and provision of written informed consent;
- •Age between 18 and 59 years, with generally good health status;
- •No use of any medications or probiotic treatments within the past 6 months;
排除标准
- •History of allergy or known hypersensitivity to probiotics, placebo, or investigational products;
- •Presence severe systemic diseases;
- •Pregnant or breastfeeding women;
- •Use of medications that may affect skin barrier function, such as corticosteroids or immunosuppressive agents;
- •Any other condition deemed inappropriate for study participation by the investigators, including but not limited to participants considered unreliable or unable to understand or comply with study assessments
研究组 & 干预措施
Arm 1: Sedentary + Placebo
- Population/behavior: Sedentary (no regular exercise habit, MET-min/week=0)
- Topical treatment: Placebo topical formulation
- Duration: 30 days (topical once daily)
干预措施: Placebo topical intervention (Other)
Arm 4: Exercise + Tripalmitoleoylglycerol
- Population/behavior: Regular aerobic exercise habit, , MET-min/week>0
- Topical treatment: 0.5% Tripalmitoleoylglycerol topical formulation
- Duration: 30 days (topical once daily)
干预措施: 0.5% Tripalmitoleoylglycerol topical intervention (Other)
Arm 2: Sedentary + Tripalmitoleoylglycerol
- Population/behavior: Sedentary (no regular exercise habit, MET-min/week=0)
- Topical treatment: 0.5% Tripalmitoleoylglycerol topical formulation
- Duration: 30 days (topical once daily)
干预措施: 0.5% Tripalmitoleoylglycerol topical intervention (Other)
Arm 3: Exercise + Placebo
- Population/behavior: Regular aerobic exercise habit, , MET-min/week>0
- Topical treatment: Placebo topical formulation
- Duration: 30 days (topical once daily)
干预措施: Placebo topical intervention (Other)
结局指标
主要结局
1. Mean change in transepidermal water loss (TEWL, g/h/m²) from baseline to Day 7 at the intervention site
时间窗: Baseline (Day 0) through Day 7 after intervention
Transepidermal water loss (TEWL) will be assessed on the marked lesion area using a Tewameter (TM300) under standardized environmental conditions (controlled temperature and humidity). At each assessment, TEWL will be measured at three predefined points within the intervention area, and the mean value will be calculated. The primary outcome is defined as the mean change in TEWL (g/h/m²) from baseline (Day 0) to Day 7 after intervention. Lower TEWL values indicate improved skin barrier function.
2. Mean change in PASI score or SCORAD index from baseline to Day 7
时间窗: Baseline (Day 0) through Day 7 after intervention
Description: Clinical severity of dermatitis will be evaluated in the intervention area by trained investigators using standardized scoring systems. Psoriasis patients will be assessed using the Psoriasis Area and Severity Index (PASI). Atopic dermatitis patients will be assessed using the SCORing Atopic Dermatitis (SCORAD) index. The outcome is defined as the change in PASI or SCORAD score from baseline (Day 0) to Day 7 after intervention, reflecting improvement in erythema, scaling, and pruritus.
1. Mean change in transepidermal water loss (TEWL, g/h/m²) from baseline to Day 30 at the intervention site
时间窗: Baseline (Day 0) through Day 30 after intervention
Transepidermal water loss (TEWL) will be assessed on the marked lesion area using a Tewameter (TM300) under standardized environmental conditions (controlled temperature and humidity). At each assessment, TEWL will be measured at three predefined points within the intervention area, and the mean value will be calculated. The primary outcome is defined as the mean change in TEWL (g/h/m²) from baseline (Day 0) to Day 30 after intervention. Lower TEWL values indicate improved skin barrier function.
2. Mean change in PASI score or SCORAD index from baseline to Day 30
时间窗: Baseline (Day 0) through Day 30 after intervention
Description: Clinical severity of dermatitis will be evaluated in the intervention area by trained investigators using standardized scoring systems. Psoriasis patients will be assessed using the Psoriasis Area and Severity Index (PASI). Atopic dermatitis patients will be assessed using the SCORing Atopic Dermatitis (SCORAD) index. The outcome is defined as the change in PASI or SCORAD score from baseline (Day 0) to Day 30 after intervention, reflecting improvement in erythema, scaling, and pruritus.
1. Mean change in transepidermal water loss (TEWL, g/h/m²) at the intervention site
时间窗: Baseline (Day 0) through Day 7 after intervention
Transepidermal water loss (TEWL) will be assessed on the marked lesion area using a Tewameter (TM300) under standardized environmental conditions (controlled temperature and humidity). At each assessment, TEWL will be measured at three predefined points within the intervention area, and the mean value will be calculated. The primary outcome is defined as the mean change in TEWL (g/h/m²) from baseline (Day 0) to Day 7 after intervention. Lower TEWL values indicate improved skin barrier function.
2. Change in clinical dermatitis severity assessed by PASI or SCORAD index
时间窗: Baseline (Day 0) through Day 7 after intervention
Description: Clinical severity of dermatitis will be evaluated in the intervention area by trained investigators using standardized scoring systems. Psoriasis patients will be assessed using the Psoriasis Area and Severity Index (PASI). Atopic dermatitis patients will be assessed using the SCORing Atopic Dermatitis (SCORAD) index. The outcome is defined as the change in PASI or SCORAD score from baseline (Day 0) to Day 7 after intervention, reflecting improvement in erythema, scaling, and pruritus.
次要结局
- 3. Change in skin surface lipase activity and palmitoleic acid levels from baseline to Day 7 assessed by skin swab metabolomics(Baseline (Day 0) through Day 7 after intervention)
- 4. Change in expression levels of inflammatory and skin barrier markers in skin biopsy samples assessed by immunohistochemistry(Day 7 after intervention)
- 3. Change in skin surface lipase activity and palmitoleic acid levels from baseline to Day 30 assessed by skin swab metabolomics(Baseline (Day 0) through Day 30 after intervention)
- 3. Skin surface lipase activity and palmitoleic acid production assessed by skin swab metabolomics(Baseline (Day 0) through Day 7 after intervention)
- 4. Immunohistochemical analysis of skin biopsy samples(Day 7 after intervention)