Safety and Efficacy of Tripalmitoleoylglycerol in Dermatitis: A Randomized Controlled Trial

Southern University of Science and Technology

Status: Not yet enrolling

Conditions: Skin Barrier to Water Loss; PASI /SCORAD Index

Treatments: Other: Placebo topical intervention; Other: 0.5% Tripalmitoleoylglycerol topical intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT07366255

82372532, 82202468 (Other Grant/Funding Number)

LL-KY-2025270-02

Details and patient eligibility

About

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：

1. 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?
2. Does physical activity status influence the therapeutic response to palmitoleic acid glyceride treatment?
3. 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 participants aged 18-59 years with clinical manifestations of chronic dermatitis and evidence of skin barrier impairment will be enrolled. Based on physical activity levels defined according to World Health Organization guidelines, participants will be stratified into physically inactive/insufficiently active and physically active/highly active groups. 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:

1. Inactive Placebo Group: No regular physical activity; topical placebo.
2. Inactive Intervention Group: No regular physical activity; topical palmitoleic acid glyceride.
3. Active Placebo Group: Regular moderate-intensity aerobic activity; topical placebo.
4. Active Intervention Group: Regular moderate-intensity aerobic activity; topical palmitoleic acid glyceride.

Participant Procedures：

1. Daily topical application of either 0.5% palmitoleic acid glyceride or placebo to a predefined skin lesion area for 7 consecutive days.
2. Non-invasive assessment of skin barrier function, including TEWL measurements, at baseline and after completion of the intervention.
3. Clinical evaluation of skin symptoms, including erythema, scaling, and pruritus, using standardized scoring systems (PASI or SCORAD, as appropriate).
4. Collection of skin swab samples for microbiome and metabolomic analyses to assess microbial lipase activity and palmitoleic acid production.
5. A subset of participants will undergo skin biopsy for histological and immunohistochemical analyses.
6. 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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 59 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria：

1. Participants must meet the latest physical activity guidelines issued by the World Health Organization and the U.S. Department of Health and Human Services, defined as follows:

   Inactive: No moderate- or vigorous-intensity physical activity beyond activities of daily living; Insufficiently active: Less than 150 minutes of moderate-intensity physical activity per week or less than 75 minutes of vigorous-intensity physical activity per week; Active: Approximately 150-300 minutes of moderate-intensity physical activity per week; Highly active: More than 300 minutes of moderate-intensity physical activity per week.

   Participants classified as inactive or insufficiently active will be assigned to the control group, whereas those classified as active or highly active will be assigned to the exercise group.

2. Presence of clinical manifestations of skin barrier impairment, such as skin dryness, erythema, scaling, or pruritus;

3. Voluntary participation with full understanding of the study and provision of written informed consent;

4. Age between 18 and 59 years, with generally good health status;

5. No use of any medications or probiotic treatments within the past 6 months;

6. No diagnosed skin diseases or skin injuries.

Exclusion Criteria：

1. History of allergy or known hypersensitivity to probiotics, placebo, or investigational products;
2. Presence of active skin diseases or other severe systemic diseases;
3. Pregnant or breastfeeding women;
4. Use of medications that may affect skin barrier function, such as corticosteroids or immunosuppressive agents;
5. 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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180 participants in 4 patient groups, including a placebo group

Arm 1: Sedentary + Placebo

Placebo Comparator group

Description:

* Population/behavior: Sedentary (no regular exercise habit, \<600MET-min/week) * Topical treatment: Placebo topical formulation * Duration: 7 days (topical once daily)

Treatment:

Other: Placebo topical intervention

Arm 2: Sedentary + Tripalmitoleoylglycerol

Experimental group

Description:

* Population/behavior: Sedentary (no regular exercise habit, \<600MET-min/week) * Topical treatment: 0.5% Tripalmitoleoylglycerol topical formulation * Duration: 7 days (topical once daily)

Treatment:

Other: 0.5% Tripalmitoleoylglycerol topical intervention

Arm 3: Exercise + Placebo

Experimental group

Description:

* Population/behavior: Regular aerobic exercise habit, , \>600MET-min/week, \<3000MET-min/week * Topical treatment: Placebo topical formulation * Duration: 7 days (topical once daily)

Treatment:

Other: Placebo topical intervention

Arm 4: Exercise + Tripalmitoleoylglycerol

Experimental group

Description:

* Population/behavior: Regular aerobic exercise habit, , \>600MET-min/week, \<3000MET-min/week * Topical treatment: 0.5% Tripalmitoleoylglycerol topical formulation * Duration: 7 days (topical once daily)

Treatment:

Other: 0.5% Tripalmitoleoylglycerol topical intervention