Strength gel with Kaempferia Parviflora Extract for improving the appearance of cellulite.

A multi-site, blinded study assessing the efficacy of a lipolytic and adipogenic agent (Kaempferia Parviflora Extract) as a treatment for cellulite

Registry ID
ISRCTN14923731
Source registry
ISRCTN
Status
Stopped
Study type
INTERVENTIONAL
Sponsor
Adipeau Inc
Enrollment
40
Start date
2025-05-21
Completion date
2026-07-21
Last update
2026-08-17

Conditions

Summary

Cellulite

Detailed description

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 "Strength 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.

Interventions

Inclusion criteria

Current inclusion criteria as of 09/02/2026: 1. Subjects with mild to severe cellulite as measured by the Merz cellulite dimple scale 2. Female subjects aged 25-75 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 Previous 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

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

Locations

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