Strength gel with Kaempferia Parviflora Extract for improving the appearance of cellulite.
| ISRCTN | ISRCTN14923731 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14923731 |
| Secondary identifying numbers | SBG-002 |
- Submission date
- 31/03/2025
- Registration date
- 12/04/2025
- Last edited
- 04/04/2025
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Skin and Connective Tissue Diseases
Plain English Summary
Background and study aims
A proof-of-concept (POC) study with the Strong Body Gel has demonstrated efficacy in the treatment of moderate to severe cellulite. No safety issues were identified in the proof of concept study that evaluated twice per day topical administration in healthy volunteers for 3 months. The current study seeks to confirm the POC results using an established cellulite grading scale (Merz cellulite dimple scale) applied by blinded evaluators.
Who can participate?
Women in generally good health aged 25 to 65 years who do not anticipate gaining or losing a large amount of weight in the coming months.
What does the study involve?
The study involves using a marketed cosmetic product (Strong Body Gel) twice per day and coming into the study centers once per month for a short session where photos will be taken.
What are the possible benefits and risks of participating?
The primary possible benefit of participating in the study is the potential to reduce the appearance of cellulite on the treated side of the body during the study (and on the untreated side of the body after the completion of the study as participants will get additional product to treat the untreated side after completing the study). There are no anticipated risks from participating in the study. The test product contains ingredients with a low risk of irritation. None of the ingredients in the test product are known to present any risk to an unborn baby.
Where is the study run from?
The study is run by Adipeau Inc., the United States of America, with study centers in the UK and Australia.
When is the study starting and how long is it expected to run for?
March 2025 to December 2025. The study starts recruiting in May 2025 and is expected to run for 3 months.
Who is funding the study?
Adipeau Inc.
Who is the main contact?
Ivan Galanin, ivan@adipeau.com
Contact information
Public, Scientific, Principal Investigator
Adipeau Inc, 8 East 96th Street
New York
10128
United States of America
 ORCID ID |
0000-0002-8991-9552 |
|---|---|
| Phone | +1 9176287920 |
| ivan@adipeau.com |
Study information
| Study design | A pre-post controlled split-body study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Community, Other therapist office, Other |
| Study type | Treatment, Safety, Efficacy |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | A multi-site, blinded study assessing the efficacy of a lipolytic and adipogenic agent (Kaempferia Parviflora Extract) as a treatment for cellulite |
| Study acronym | KPE-FORCEL |
| Study hypothesis | The principal hypothesis being tested is that a topical cosmetic product comprising Kaempferia Parviflora Extract can improve the appearance of cellulite as evaluated by the Merz cellulite scale. |
| Ethics approval(s) | Ethics approval not required |
| Ethics approval additional information | The study evaluates a cosmetic product that is publicly available without a prescription for topical use and has a strong safety profile. |
| Condition | Cellulite |
| Intervention | This pre-post study compares the effect of the test product vs. no product on the appearance of cellulite severity at specific target areas. The treatment comprises the cosmetic product "Strong Body Gel" registered in the EU and UK. The subject will administer sufficient amounts of the test product to cover areas of cellulite on the treatment target areas on the right side of their bodies twice per day, in the morning and the evening. The amount to be applied depends on the size of the treated area, but ranges from a US nickel-sized dollop to a US quarter-sized dollop. Up to 8 target areas of cellulite severity will be selected for evaluation by each study coordinator after the baseline visit photography. Up to 4 target areas are to be treated with the Test Product on the right side of the body, and up to 4 areas on the left side of the body will not be treated. Cellulite appearance will be documented by 2D imaging at 5 study sites and by 3D imaging at one of the 5 study sites. The subjects are not blinded. The 2D imaging results will be assessed by blinded evaluators who will not know which images are pre- or post-treatment. Subjects are required to visit the study center every 4 weeks for evaluation. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Kaempferia Parviflora Extract Strong Body Gel |
| Primary outcome measure | The grade of cellulite severity measured using the Merz Aesthetics cellulite dimple grading scales by blinded evaluators at 12 weeks |
| Secondary outcome measures | 1. The grade of cellulite severity measured using the Merz Aesthetics cellulite dimple grading scales by blinded evaluators at baseline and after 12 weeks 2. Cellulite severity measured using Antera 3D imaging at baseline and after 12 weeks 3. The ability of evaluators to identify “before” images based on a higher cellulite severity grade being assigned to those images according to the Merz cellulite dimple scale at one time point |
| Overall study start date | 21/03/2025 |
| Overall study end date | 21/12/2025 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 25 Years |
| Upper age limit | 65 Years |
| Sex | Female |
| Target number of participants | 40 |
| Total final enrolment | 48 |
| Participant inclusion criteria | 1. Subjects with mild to severe cellulite as measured by the Merz cellulite dimple scale 2. Female subjects aged 25-65 years 3. Subjects with Fitzpatrick skin types I-VI 4. Subjects who are dependable and able to follow directions, and willing to comply with the schedule of visits 5. Subjects in generally good physical and mental health |
| Participant exclusion criteria | 1. Subjects diagnosed or treated for lipedema or lymphedema 2. Subjects with known allergies to the ingredients in the Test Product 3. Subjects who are pregnant or nursing 4. Subjects who anticipate engaging in activities that would result in significant weight loss or gain in the three months following screening |
| Recruitment start date | 21/05/2025 |
| Recruitment end date | 21/07/2025 |
Locations
Countries of recruitment
- Australia
- England
- United Kingdom
- United States of America
Study participating centres
Gravesend
DA12 1JT
United Kingdom
Bozeman
59715
United States of America
Rancho Santa Margarita
92688
United States of America
Orlando
32803
United States of America
Mornington
3931
Australia
Sponsor information
Industry
8 East 96th Street
New York
10128
United States of America
| Website | https://adipeau.com/ |
|---|
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 30/06/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date. |
Editorial Notes
04/04/2025: Study's existence confirmed by the study coordinators of the study participating centres, Non-Surgical Youth & Beauty Clinic, USA, and Skin by Summer, Australia.
