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

NCT07862920 | Not Yet Recruiting

• 2 other identifiers: 2026-026PBR Foundation funds
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Thigh Cellulite

Keywords

Topical Fat Reduction; Smoothness of thigh skin; Lipolysis

Outcome Measures

Primary Outcomes (1)

• Thigh girth

  Difference in girth between treated and placebo thigh

  Cream application twice a day for 8 weeks

Study Arms (2)

Thigh reduction Cream

EXPERIMENTAL

naringenin, beta carotene with menthol cream

Other: Thigh Reduction Cream

Thigh treated with placebo cream

PLACEBO COMPARATOR

Placebo cream used twice a day on the control thigh

Other: Placebo Cream

Interventions

Thigh Reduction Cream OTHER

naringenn, beta carotene with menthol cream

Thigh reduction Cream

Placebo Cream OTHER

Placebo cream added twice a day on control thigh

Thigh treated with placebo cream

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: only biological females that have a gender identity as females
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• Frank Greenway: lead
• Pennington Biomedical Research Center: collaborator

Related Publications (1)

• 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.

  PMID: 8697059 BACKGROUND

Related Links

• Topical Fat Reduction from the Waist
• Thigh girth loss in women with lower body fat distribution increases breast volume
• Naringenin and β-carotene convert human white adipocytes to a beige phenotype and elevate hormone- stimulated lipolysis

Study Officials

• Cody VanMeter, MBA

  Cody.VanMeter@pbrc.edu

  STUDY DIRECTOR

Central Study Contacts

Alison Carville, BA

CONTACT

225-763-2660; alison.carville@pbrc.edu

Grace Bella, BA

CONTACT

225-763-2602; Grace.Bella@pbrc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Director and Professor

Model Details: 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

Study Record Dates

• First Submitted: October 2, 2026
• First Posted: October 7, 2026
• Study Start (Estimated): January 15, 2027
• Primary Completion (Estimated): July 15, 2027
• Study Completion (Estimated): July 15, 2027
• Last Updated: October 7, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• 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.