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The purpose of this study was to determine whether DermaFIT cream, a topical intervention designed to attenuate sarcopenia, can improve muscle health and physical function in older adults.

Effects of a Topical Exosome-Based Cream on Regional Muscle Quality and Body Composition in Older Adults: A 12-Week Randomized, Double-Blind, Placebo-Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0012171
Enrollment
100
Registered
2026-06-24
Start date
2025-07-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Others(Topical cream (exosome-based transdermal formulation) and bodyweight exercise) : Intervention Description Participants were randomly assigned to one of four groups: 1. Active Cream + Exercise

Sponsors

Seoul National University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Men and women aged 65 years and older

Exclusion criteria

Exclusion criteria: Participants meeting any of the following criteria were excluded: 1) Use of medications or dietary supplements that may affect muscle health within 2 weeks prior to the screening visit (e.g., protein powder, amino acid supplements, creatine supplements, Schisandra chinensis extract). 2) Participation in regular high-intensity exercise training within 3 months prior to the baseline visit. 3) History of major surgery within 6 months prior to the baseline visit. 4) Participation in another clinical trial within 1 month prior to the baseline visit or plans to participate in another clinical trial during the study period. 5) Presence of skin conditions that may interfere with topical application of the study product, including skin rash, wounds, or irritation. 6) Severe chronic diseases, including renal failure or liver disease. 7) Diagnosis of severe cerebrovascular disease (e.g., cerebral infarction, intracerebral hemorrhage), cardiovascular disease (e.g., angina, myocardial infarction, heart failure, arrhythmia), or pulmonary disease (e.g., chronic obstructive pulmonary disease) within 3 months prior to the screening visit. 8) Uncontrolled diabetes mellitus (fasting blood glucose >126 mg/dL). 9) Uncontrolled hypertension (systolic blood pressure =160 mmHg or diastolic blood pressure =100 mmHg). 10) Use of oral steroids or corticosteroids within 4 weeks prior to the screening visit. 11) Difficulty using a smartphone or computer. 12) Cognitive impairment or dementia that may interfere with study participation. 13) Any condition that, in the opinion of the investigator, would make participation in the study inappropriate.

Design outcomes

Primary

MeasureTime frame
intramuscular lipid content, muscle quality index, and water content assessed by near-infrared spectroscopy (FITTO);Skeletal muscle mass and body fat mass assessed by bioelectrical impedance analysis (InBody 770)

Secondary

MeasureTime frame
Whole-body fat mass assessed by near-infrared spectroscopy (FITTO);Isokinetic knee flexion strength (peak torque and total work normalized to body weight) at 60°/s;Lower-extremity physical function assessed by Short Physical Performance Battery (SPPB) and Timed Up and Go (TUG) test;Grip strength (Takei);Isokinetic knee extension strength (peak torque and total work normalized to body weight) at 60°/s

Countries

Korea, Republic of

Contacts

Public ContactYunho Sung

Seoul National University

sungyunho@snu.ac.kr+82-2-886-7804

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Jul 3, 2026