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RJV001 Study in Adults Receiving Abdominoplasty

NCT04821648 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2022-01-18

No results posted yet for this study

Summary

In this study, we are testing a new drug against submental fat (SMF), which is characterized with the accumulation of fat under the chin that often appears as a "double chin". The 2018 American Society for Dermatologic Surgery Consumer Survey on Cosmetic Dermatologic Procedures indicated that 73% of respondents were bothered by "excess fat under the chin/neck". This condition of loose or sagging skin under the chin may affect facial symmetry and attractiveness, which can lead to social embarrassment and a negative self-image in many patients.

There is an insufficiency in effective drugs against SMF and double chin. Although an injectable small molecule can be used for improvement of double chin, but its side effects are evident and its cost is high. As such, there remains a real need to develop a cost-effective method to improve appearance of SMF and double chin.

Conditions

  • Submental Fat (SMF)
  • Double Chin

Interventions

DRUG

RJV001

Subcutaneous injection in the abdomen

DRUG

Placebo

The placebo formulation has the same shape, color, and qualitative composition as the RJV001 freeze dried powder, with the exception that RJV001 drug substance has been removed. For each cohort group, a placebo will be injected in a single site in the same area as the treatment.

Sponsors & Collaborators

  • Rejuven Dermaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Joseph Gimbel, M.D. · Arizona Research Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-16
Primary Completion
2021-12-16
Completion
2021-12-16
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04821648 on ClinicalTrials.gov