A clinical study to evaluate the effects of a fat cell targeted gel for body skin laxity

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Plain English summary of protocol not provided at time of registration

Mr Ivan Galanin
Public, Scientific, Principal investigator

8 East 96th Street
New York
10128
United States of America

Primary study design	Interventional
Allocation	N/A: single arm study
Masking	Open (masking not used)
Control	Uncontrolled
Assignment	Single
Purpose	Treatment
Scientific title	A clinical study to validate the laxity reduction effects of a dual-acting lipolytic/adipogenic gel
Study objectives	This study will evaluate whether a gel that improves the fitness of skin fat cells can improve the appearance of weak skin on the legs and buttocks. The study aims to demonstrate improvement in laxity severity at Week 12 compared to baseline.
Ethics approval(s)	Ethics approval not required
Health condition(s) or problem(s) studied	Healthy adults
Intervention	Strength Gel (Adipeau Inc), a marketed topical cosmetic containing Kaempferia Parviflora Extract as an active ingredient, was applied by participants 2x per day in a thin layer to areas of skin laxity.
Intervention type	Other
Primary outcome measure(s)	Laxity severity measured using the Laxity Scale at baseline and 3 months
Key secondary outcome measure(s)	Objective skin texture measurement measured using selected outputs of Antera 3D imaging (e.g., skin texture, large wrinkles, dimpling, elevations) at baseline and 3 months
Completion date	14/08/2026

Participant type(s)
Age group	Mixed
Lower age limit	45 Years
Upper age limit	75 Years
Sex	Female
Target sample size at registration	30
Total final enrolment	35
Key inclusion criteria	Moderate to severe skin laxity on the legs and/or buttocks.
Key exclusion criteria	Anticipated changes to body composition through new exercise regimens, weight loss or major lifestyle changes.
Date of first enrolment	13/02/2026
Date of final enrolment	14/05/2026

Ageless Aesthetics by HB Walsh

650 Berkeley Ave
Berkeley Township
08721
United States of America

South County Microspa

195 Montana Del Lago Drive
Rancho Santa Margarita
92688
United States of America

Advanced Skin by Summer

50 Tallis Drive
Mornington
3931
Australia

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	All de-identified cropped images used in the analysis of efficacy endpoints to be made available to researchers.

13/02/2026: Study’s existence confirmed by the Ageless Aesthetics by HB Walsh, USA.