Skin Barrier to Water LossNCT07366255
Safety and Efficacy of Tripalmitoleoylglycerol in the Treatment of Dermatitis
A study testing 0.5% Tripalmitoleoylglycerol topical intervention in people with Skin Barrier to Water Loss and PASI /SCORAD Index, run by Shenzhen People's Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Skin Barrier to Water Loss, PASI /SCORAD Index
- What is being tested?
- 0.5% Tripalmitoleoylglycerol topical intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteChina
- Study dates
- 10 Jan 2026to 8 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
- 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;
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Dermatology, Shenzhen People's Hospital
Shenzhen, Guangdong, 518000
About this study
Official title: 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.
Read more
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.
- Conditions
- Skin Barrier to Water Loss, PASI /SCORAD Index
- Being tested
- Placebo topical intervention, 0.5% Tripalmitoleoylglycerol topical intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo topical interventionOther
Placebo topical intervention applied continuously for 30 days (once daily).
0.5% Tripalmitoleoylglycerol topical interventionOther
0.5% Tripalmitoleoylglycerol topical intervention applied continuously for 30 days (once daily).
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Sedentary + Placebo | Placebo comparator | * Population/behavior: Sedentary (no regular exercise habit, MET-min/week=0)
* Topical treatment: Placebo topical formulation
* Duration: 30 days (topical once daily) Receives: Other: Placebo topical intervention |
| Arm 2: Sedentary + Tripalmitoleoylglycerol | Experimental | * Population/behavior: Sedentary (no regular exercise habit, MET-min/week=0)
* Topical treatment: 0.5% Tripalmitoleoylglycerol topical formulation
* Duration: 30 days (topical once daily) Receives: Other: 0.5% Tripalmitoleoylglycerol topical intervention |
| Arm 3: Exercise + Placebo | Experimental | * Population/behavior: Regular aerobic exercise habit, , MET-min/week>0
* Topical treatment: Placebo topical formulation
* Duration: 30 days (topical once daily) Receives: Other: Placebo topical intervention |
| Arm 4: Exercise + Tripalmitoleoylglycerol | Experimental | * Population/behavior: Regular aerobic exercise habit, , MET-min/week>0
* Topical treatment: 0.5% Tripalmitoleoylglycerol topical formulation
* Duration: 30 days (topical once daily) Receives: Other: 0.5% Tripalmitoleoylglycerol topical intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Mean change in transepidermal water loss (TEWL, g/h/m²) from baseline to Day 30 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 30 after intervention. Lower TEWL values indicate improved skin barrier function.
Measured: Baseline (Day 0) through Day 30 after intervention
2. Mean change in PASI score or SCORAD index from baseline to Day 30
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.
Measured: Baseline (Day 0) through Day 30 after intervention
Secondary outcomes (1)
3. Change in skin surface lipase activity and palmitoleic acid levels from baseline to Day 30 assessed by skin swab metabolomics
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.
Measured: Baseline (Day 0) through Day 30 after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start10 Jan 2026
- Primary completion5 Mar 2026
- Study completion8 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin Barrier to Water LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shenzhen People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07366255
- Sponsor's protocol ID
- LL-KY-2025270-02
- Other IDs
- 82372532, 82202468
- Status last verified
- Mar 2026
- First submitted
- 17 Jan 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Tripalmitoleoylglycerol for the Treatment of Dermatitis.
- ClinicalTrials.gov ID
- NCT07366255
- Acronym / sponsor ID
- LL-KY-2025270-02
- Conditions
- Skin Barrier to Water Loss, PASI /SCORAD Index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Shenzhen People's HospitalUniversity, hospital or other
- Study start
- 10 Jan 2026 (actual)
- Primary completion
- 5 Mar 2026 (actual)
- Study completion
- 8 Mar 2026 (actual)
- First posted
- 26 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Sedentary + Placebo | Placebo comparator | Other: Placebo topical intervention* Population/behavior: Sedentary (no regular exercise habit, MET-min/week=0) * Topical treatment: Placebo topical formulation * Duration: 30 days (topical once daily) |
| Arm 2: Sedentary + Tripalmitoleoylglycerol | Experimental | Other: 0.5% Tripalmitoleoylglycerol topical intervention* Population/behavior: Sedentary (no regular exercise habit, MET-min/week=0) * Topical treatment: 0.5% Tripalmitoleoylglycerol topical formulation * Duration: 30 days (topical once daily) |
| Arm 3: Exercise + Placebo | Experimental | Other: Placebo topical intervention* Population/behavior: Regular aerobic exercise habit, , MET-min/week>0 * Topical treatment: Placebo topical formulation * Duration: 30 days (topical once daily) |
| Arm 4: Exercise + Tripalmitoleoylglycerol | Experimental | Other: 0.5% Tripalmitoleoylglycerol topical intervention* Population/behavior: Regular aerobic exercise habit, , MET-min/week>0 * Topical treatment: 0.5% Tripalmitoleoylglycerol topical formulation * Duration: 30 days (topical once daily) |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
- 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;
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo topical interventionPlacebo topical intervention applied continuously for 30 days (once daily). | Other | Arm 1: Sedentary + Placebo, Arm 3: Exercise + Placebo |
| 0.5% Tripalmitoleoylglycerol topical intervention0.5% Tripalmitoleoylglycerol topical intervention applied continuously for 30 days (once daily). | Other | Arm 2: Sedentary + Tripalmitoleoylglycerol, Arm 4: Exercise + Tripalmitoleoylglycerol |
Primary outcome
1. Mean change in transepidermal water loss (TEWL, g/h/m²) from baseline to Day 30 at the intervention site
Time frame: 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
Time frame: 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 secondary outcome
3. Change in skin surface lipase activity and palmitoleic acid levels from baseline to Day 30 assessed by skin swab metabolomics
Time frame: Baseline (Day 0) through Day 30 after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 0.5% Tripalmitoleoylglycerol topical intervention in people with Skin Barrier to Water Loss and PASI /SCORAD Index, run by Shenzhen People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Mean change in transepidermal water loss (TEWL, g/h/m²) from baseline to Day 30 at the intervention site (time frame: Baseline (Day 0) through Day 30 after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.