ClinicalTrials.gg
Not yet recruitingNCT07862920SCULPTUpdated Oct 7, 2026

Pilot Study of Naringenin Beta Carotene Cream for Local Fat Reduction (SCULPT)

An interventional study of Thigh Reduction Cream and Placebo Cream in Thigh Cellulite, sponsored by Frank Greenway. Not yet recruiting. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-10-07.

Sponsored by Frank Greenway · Not applicable, Interventional, and Treatment

Updated Oct 7, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Female
01

Study 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 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.

02

Conditions studied

  • Thigh Cellulite

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Keywords

  • Topical Fat Reduction
  • Smoothness of thigh skin
  • Lipolysis
03

In context

Cellulite

71 studies on the registry are indexed under Cellulite; 3 are open to participants now.

This study's planned enrollment of 10 is below the median of 34 across 65 interventional studies indexed under Cellulite.

Browse Cellulite studies →

Lead sponsor

Frank Greenway is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria: 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 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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Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    Thigh reduction Cream

    naringenin, beta carotene with menthol cream

    Other: Thigh Reduction Cream

  • Placebo comparator
    Thigh treated with placebo cream

    Placebo cream used twice a day on the control thigh

    Other: Placebo Cream

Interventions

  • OtherThigh Reduction Cream

    naringenn, beta carotene with menthol cream

  • OtherPlacebo Cream

    Placebo cream added twice a day on control thigh

06

What researchers measure

Primary outcomes

  1. Thigh girth

    Difference in girth between treated and placebo thigh

    Time frame: Cream application twice a day for 8 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

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 ↗

Individual participant data

Plan to share: Yes — Results will be available for review by scientists needing that information from the Nutrition Obesity Research Center repository at Pennington Biomedical Research Center

Supporting information: Study protocol, Informed consent form, Clinical study report

Time frame: Estimated to be July 1, 2027

Access criteria: Scientists have need for the individual patient data will be able to obtain it trough the Nutrition Obesity Research Center at Pennington Biomedical Research Center.

Data sharing details ↗ · www.bing.com

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jan 2027; primary completion for Jul 2027, 6 months later.

Of 20 interventional studies with no phase under Cellulite, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 14. This study's planned 6 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 2, 2026
First posted
Oct 7, 2026
StartEst.
Jan 15, 2027
Primary completionEst.
Jul 15, 2027
CompletionEst.
Jul 15, 2027
Last update
Oct 7, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 7, 2026
Show all 1 update
  1. Oct 7, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07862920
Lead sponsor
Frank Greenway
Responsible party
Frank Greenway (Medical Director and Professor, Pennington Biomedical Research Center) — Sponsor-investigator
First posted
Oct 7, 2026
Start date
Jan 15, 2027 (estimated)
Primary completion
Jul 15, 2027 (estimated)
Completion
Jul 15, 2027 (estimated)
Last update
Oct 7, 2026

Study contacts

Alison Carville, BA
Contact
alison.carville@pbrc.edu
225-763-2660
Grace Bella, BA
Contact
Grace.Bella@pbrc.edu
225-763-2602
Cody VanMeter, MBA
study director · Cody.VanMeter@pbrc.edu

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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