Thigh CelluliteSCULPTNCT07862920
Pilot Study of Naringenin Beta Carotene Cream for Local Fat Reduction (SCULPT)
A study testing Thigh Reduction Cream in people with Thigh Cellulite, run by Frank Greenway.
Trial summary
this study tests the hypothesis that naringenin, beta carotene and menthol cream when applied to one thigh and a placebo cream to the other twice a day will result in greater loss of girth, smoother appearance of the skin and a greater increase in lipolysis on the treated vs. the placebo cream over 8 weeks Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Thigh Cellulite
- What is being tested?
- Thigh Reduction Cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2027to 15 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Inclusion Criteria: BMI 25-35 kg/m2, Stable weight +/- 3kg in last 2 months, self-reported cellulite -
Exclusion Criteria: women of child bearing potential who do not agree to use an effective contraception method during the trial, lymphedema, skin problems precluding use of a cream, allergy to citrus fruit, carrots mint, skin disease of the thighs like psoriasis, eczema, contact dermatitis or other skin disease of the thighs, and vulnerable populations like children, prisoners, pregnant women or people unable to give consent.
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Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
this study tests the hypothesis that naringenin, beta carotene and menthol cream when applied to one thigh and a placebo cream to the other twice a day will result in greater loss of girth, smoother appearance of the skin and a greater increase in lipolysis on the treated vs. the placebo cream over 8 weeks
Read the detailed description
10 women 18 to 50 years of age who are overweight or obese and desire smaller and smoother thighs will have size assessed by measuring girth and smoothness assessed by photographs at baseline and at the end of the study at week 8. Lipolysis will be assessed by microdialysis.
- Conditions
- Thigh Cellulite
- Being tested
- Thigh Reduction Cream, Placebo Cream
- Keywords
- Topical Fat Reduction, Smoothness of thigh skin, Lipolysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thigh Reduction CreamOther
naringenn, beta carotene with menthol cream
Placebo CreamOther
Placebo cream added twice a day on control thigh
| Study group | Role | What they receive |
|---|---|---|
| Thigh reduction Cream | Experimental | naringenin, beta carotene with menthol cream Receives: Other: Thigh Reduction Cream |
| Thigh treated with placebo cream | Placebo comparator | Placebo cream used twice a day on the control thigh Receives: Other: Placebo Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thigh girth
Difference in girth between treated and placebo thigh
Measured: Cream application twice a day for 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study start15 Jan 2027 (estimated)
- Primary completion15 Jul 2027 (estimated)
- Study completion15 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thigh CelluliteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- One thigh is treated with an active cream and the other is treated with a placebo cream and the two thighs treated in parallel will be compared
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Frank Greenway
- Sponsor type
- University, hospital or other
- Collaborators
- Pennington Biomedical Research Center
- Responsible party
- Sponsor-investigator, Frank Greenway, Pennington Biomedical Research Center
- Investigators
- Cody VanMeter, MBA, Study director, Cody.VanMeter@pbrc.edu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07862920
- Sponsor's protocol ID
- 2026-026
- Other IDs
- PBR Foundation funds
- Acronym
- SCULPT
- Status last verified
- Sep 2026
- First submitted
- 2 Oct 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Results will be available for review by scientists needing that information from the Nutrition Obesity Research Center repository at Pennington Biomedical Research Center
Publications
Greenway FL, Bray GA, Heber D. Topical fat reduction. Obes Res. 1995 Nov;3 Suppl 4:561S-568S. doi: 10.1002/j.1550-8528.1995.tb00228.x.
PubMed 8697059
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Naringenin Beta Carotene Cream for Local Fat Reduction (SCULPT)
- ClinicalTrials.gov ID
- NCT07862920
- Acronym / sponsor ID
- SCULPT / 2026-026
- Conditions
- Thigh Cellulite
- Keywords
- Topical Fat Reduction, Smoothness of thigh skin, Lipolysis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Frank GreenwayUniversity, hospital or other
- Collaborators
- Pennington Biomedical Research Center
- Study start
- 15 Jan 2027 (estimated)
- Primary completion
- 15 Jul 2027 (estimated)
- Study completion
- 15 Jul 2027 (estimated)
- First posted
- 7 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
this study tests the hypothesis that naringenin, beta carotene and menthol cream when applied to one thigh and a placebo cream to the other twice a day will result in greater loss of girth, smoother appearance of the skin and a greater increase in lipolysis on the treated vs. the placebo cream over 8 weeks
Detailed description
10 women 18 to 50 years of age who are overweight or obese and desire smaller and smoother thighs will have size assessed by measuring girth and smoothness assessed by photographs at baseline and at the end of the study at week 8. Lipolysis will be assessed by microdialysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- One thigh is treated with an active cream and the other is treated with a placebo cream and the two thighs treated in parallel will be compared
| Arm | Type | Receives |
|---|---|---|
| Thigh reduction Cream | Experimental | Other: Thigh Reduction Creamnaringenin, beta carotene with menthol cream |
| Thigh treated with placebo cream | Placebo comparator | Other: Placebo CreamPlacebo cream used twice a day on the control thigh |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thigh Reduction Creamnaringenn, beta carotene with menthol cream | Other | Thigh reduction Cream |
| Placebo CreamPlacebo cream added twice a day on control thigh | Other | Thigh treated with placebo cream |
Primary outcome
Thigh girth
Time frame: Cream application twice a day for 8 weeks
Difference in girth between treated and placebo thigh
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Background: PubMed 8697059Greenway FL, Bray GA, Heber D. Topical fat reduction. Obes Res. 1995 Nov;3 Suppl 4:561S-568S. doi: 10.1002/j.1550-8528.1995.tb00228.x.
- Topical Fat Reduction from the WaistLink provided by the sponsor.
- Thigh girth loss in women with lower body fat distribution increases breast volumeLink provided by the sponsor.
- Naringenin and β-carotene convert human white adipocytes to a beige phenotype and elevate hormone- stimulated lipolysisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Results will be available for review by scientists needing that information from the Nutrition Obesity Research Center repository at Pennington Biomedical Research Center
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cody VanMeter, MBA study director
Cody.VanMeter@pbrc.edu
Questions about this trial
What is this clinical trial studying?
A study testing Thigh Reduction Cream in people with Thigh Cellulite, run by Frank Greenway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alison Carville, BA (225-763-2660, alison.carville@pbrc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thigh girth (time frame: Cream application twice a day for 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07862920, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.