Safety and Efficacy of Tripalmitoleoylglycerol in the Treatment of Dermatitis

March 31, 2026 updated by: Shenzhen People's Hospital

A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Tripalmitoleoylglycerol for the Treatment of Dermatitis.

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/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:

  1. Inactive Placebo Group: No regular physical activity; topical placebo.
  2. Inactive Intervention Group: No regular physical activity; topical tripalmitoleoylglycerol.
  3. Active Placebo Group: Regular physical activity; topical placebo.
  4. Active Intervention Group: Regular physical activity; topical tripalmitoleoylglycerol.

Participant Procedures：

  1. Daily topical application of either 0.5% tripalmitoleoylglycerol 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
46

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Yue Li
  • Phone Number: +86 13502729696

Study Locations

  • China
    • Guangdong
      • Shenzhen, Guangdong, China, 518000
        • Department of Dermatology, Shenzhen People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria：

  1. 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 0.
  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;

Exclusion Criteria：

  1. History of allergy or known hypersensitivity to probiotics, placebo, or investigational products;
  2. Presence 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Arm 1: Sedentary + Placebo
  • Population/behavior: Sedentary (no regular exercise habit, MET-min/week=0)
  • Topical treatment: Placebo topical formulation
  • Duration: 7 days (topical once daily)
Other: Placebo topical intervention
Placebo topical intervention applied continuously for 7 days (once daily).
Experimental: Arm 2: Sedentary + Tripalmitoleoylglycerol
  • Population/behavior: Sedentary (no regular exercise habit, MET-min/week=0)
  • Topical treatment: 0.5% Tripalmitoleoylglycerol topical formulation
  • Duration: 7 days (topical once daily)
Other: 0.5% Tripalmitoleoylglycerol topical intervention
0.5% Tripalmitoleoylglycerol topical intervention applied continuously for 7 days (once daily).
Experimental: Arm 3: Exercise + Placebo
  • Population/behavior: Regular aerobic exercise habit, , MET-min/week>0
  • Topical treatment: Placebo topical formulation
  • Duration: 7 days (topical once daily)
Other: Placebo topical intervention
Placebo topical intervention applied continuously for 7 days (once daily).
Experimental: Arm 4: Exercise + Tripalmitoleoylglycerol
  • Population/behavior: Regular aerobic exercise habit, , MET-min/week>0
  • Topical treatment: 0.5% Tripalmitoleoylglycerol topical formulation
  • Duration: 7 days (topical once daily)
Other: 0.5% Tripalmitoleoylglycerol topical intervention
0.5% Tripalmitoleoylglycerol topical intervention applied continuously for 7 days (once daily).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
1. Mean change in transepidermal water loss (TEWL, g/h/m²) from baseline to Day 7 at the intervention site
Time Frame: 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.
Baseline (Day 0) through Day 7 after intervention
2. Mean change in PASI score or SCORAD index from baseline to Day 7
Time Frame: 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.
Baseline (Day 0) through Day 7 after intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
3. Change in skin surface lipase activity and palmitoleic acid levels from baseline to Day 7 assessed by skin swab metabolomics
Time Frame: Baseline (Day 0) through Day 7 after intervention

Skin swab samples will be collected from the intervention site in both sedentary and exercise groups at baseline and after intervention. Targeted metabolomic analyses will be performed to evaluate skin surface lipase activity and the metabolism of glycerides into palmitoleic acid.

The outcome is defined as the change in skin surface lipase activity and palmitoleic acid levels between baseline and post-intervention.
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
Time Frame: Day 7 after intervention

Skin biopsy samples (3-4 mm) will be obtained from a subset of participants (3-4 individuals per group) in both sedentary and exercise groups. Immunohistochemical staining will be performed to assess changes in inflammatory markers and skin barrier-related proteins.

This outcome is exploratory and intended to support mechanistic interpretation of clinical findings.
Day 7 after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shenzhen People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 10, 2026

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 5, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 8, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 17, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 17, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 26, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LL-KY-2025270-02
  • 82372532, 82202468 (Other Grant/Funding Number: National Natural Science Foundation of China)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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