Clinical Research Directory

Safety and Efficacy of Tripalmitoleoylglycerol in 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 30 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. 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.

A Study on the Efficacy of 2% Cholesterol Cream in Atopic Dermatitis

Atopic dermatitis is a common chronic inflammatory skin condition characterized by impaired skin barrier function, leading to increased transepidermal water loss (TEWL), dry skin, and itching. Restoration of the skin barrier is an important component of treatment. Cholesterol is a key lipid in the stratum corneum that plays a role in maintaining skin barrier integrity. This study aims to evaluate the efficacy and safety of 2% cholesterol cream in improving skin barrier function and clinical symptoms in patients with mild to moderate atopic dermatitis aged 7-17 years. Participants will be randomly assigned to receive either 2% cholesterol cream or a placebo (cream base), applied twice daily for 12 weeks. Outcomes will include measurements of transepidermal water loss (TEWL), skin hydration, skin pH, Investigator's Global Assessment (IGA), Eczema Area and Severity Index (EASI), and pruritus numeric rating scale (NRS). The results of this study may support the use of cholesterol-containing topical formulations as a safe and effective treatment option for atopic dermatitis.

Clinical Evaluation of an Atopic Skin Product Containing Picea Abies Resin Extract

This study evaluates the repairing efficacy of a cosmetic cream containing Picea abies extract compared to a placebo (cream without extract) and a benchmark product. The trial involves 60 healthy subjects (aged 18-60) with atopy-prone and sensitive skin. Over a 21-day period, the primary objective is to measure improvements in skin barrier function via transepidermal water loss (TEWL) and skin moisturization. A dermatologist will also assess soothing effects by evaluating skin dryness, redness, and itching sensations. Secondary objectives include measuring skin inflammation markers (TNFα, TSLP, and TARC) and subject-perceived efficacy through self-assessment questionnaires.

Oral Lactobacillus Reuteri for Skin Barrier Dysfunction in Obesity

This clinical trial aims to evaluate the safety and efficacy of oral Lactobacillus reuteri supplementation for treating obesity-induced skin barrier impairment in individuals aged 18-40 with a BMI ≥30. The study focuses on the following questions: Can oral Lactobacillus reuteri supplementation reduce skin barrier damage (measured by transepidermal water loss/TEWL) in obese participants? Does modulation of gut microbiota with Lactobacillus reuteri impact skin barrier function and systemic inflammation? Researchers will compare outcomes across two groups: Intervention Group (Obese): Oral Lactobacillus reuteri capsules. Placebo Control Group (Obese): Oral inactive (heat-killed) Lactobacillus reuteri. Participant Procedures: Take daily oral capsules (Lactobacillus reuteri or inactive strain) for 4 weeks. Undergo non-invasive skin testing (TEWL measurements) at baseline and study completion. Provide stool and samples for analyses. Complete weekly check-ins to report adverse effects (e.g., gastrointestinal discomfort, skin irritation).