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

NCT07366255 | Not Yet Recruiting

• 2 other identifiers: LL-KY-2025270-0282372532, 82202468
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

Brief Summary

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. 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. 2.Does physical activity status influence the therapeutic response to palmitoleic acid glyceride treatment?
3. 3.Are improvements in skin barrier function associated with changes in skin microbiota composition, microbial lipase activity, and lipid metabolism at the skin surface?
4. 4.Inactive Placebo Group: No regular physical activity; topical placebo.
5. 5.Inactive Intervention Group: No regular physical activity; topical palmitoleic acid glyceride.
6. 6.Active Placebo Group: Regular moderate-intensity aerobic activity; topical placebo.
7. 7.Active Intervention Group: Regular moderate-intensity aerobic activity; topical palmitoleic acid glyceride.
8. 8.Daily topical application of either 0.5% palmitoleic acid glyceride or placebo to a predefined skin lesion area for 7 consecutive days.
9. 9.Non-invasive assessment of skin barrier function, including TEWL measurements, at baseline and after completion of the intervention.
10. 10.Clinical evaluation of skin symptoms, including erythema, scaling, and pruritus, using standardized scoring systems (PASI or SCORAD, as appropriate).
11. 11.Collection of skin swab samples for microbiome and metabolomic analyses to assess microbial lipase activity and palmitoleic acid production.
12. 12.A subset of participants will undergo skin biopsy for histological and immunohistochemical analyses.
13. 13.Weekly follow-up assessments to monitor treatment adherence and record any adverse events, particularly local skin reactions.

Conditions

Skin Barrier to Water Loss; PASI /SCORAD Index

Outcome Measures

Primary Outcomes (2)

• 1. Mean change in transepidermal water loss (TEWL, g/h/m²) at the intervention site

  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.

  Baseline (Day 0) through Day 7 after intervention

• 2. Change in clinical dermatitis severity assessed by PASI or SCORAD index

  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.

  Baseline (Day 0) through Day 7 after intervention

Secondary Outcomes (2)

• 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

Study Arms (4)

Arm 1: Sedentary + Placebo

PLACEBO COMPARATOR

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

Other: Placebo topical intervention

Arm 2: Sedentary + Tripalmitoleoylglycerol

EXPERIMENTAL

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

Other: 0.5% Tripalmitoleoylglycerol topical intervention

Arm 3: Exercise + Placebo

EXPERIMENTAL

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

Other: Placebo topical intervention

Arm 4: Exercise + Tripalmitoleoylglycerol

EXPERIMENTAL

* 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)

Other: 0.5% Tripalmitoleoylglycerol topical intervention

Interventions

Placebo topical intervention OTHER

Placebo topical intervention applied continuously for 7 days (once daily).

Arm 1: Sedentary + Placebo; Arm 3: Exercise + Placebo

0.5% Tripalmitoleoylglycerol topical intervention OTHER

0.5% Tripalmitoleoylglycerol topical intervention applied continuously for 7 days (once daily).

Arm 2: Sedentary + Tripalmitoleoylglycerol; Arm 4: Exercise + Tripalmitoleoylglycerol

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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;
• No diagnosed skin diseases or skin injuries.

You may not qualify if:

• History of allergy or known hypersensitivity to probiotics, placebo, or investigational products;
• Presence of active skin diseases or other 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

Sponsors & Collaborators

• Shenzhen People's Hospital: lead

Central Study Contacts

Jianglin Zhang

CONTACT

+86 13873143466; zhang.jianglin@szhospital.com

Yue Li

CONTACT

+86 13502729696

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2026
• First Posted: January 26, 2026
• Study Start: December 28, 2025
• Primary Completion: January 25, 2026
• Study Completion: February 4, 2026
• Last Updated: January 26, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share