An Open Label Study of Participants with Moderate or Severe Cellulite to Evaluate Focal Contouring.

Not Applicable

Completed

• Conditions: Cellulite; Skin - Other skin conditions

• Registration Number: ACTRN12619001208190
• Lead Sponsor: Revelle Aesthetics Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-08-30
• Study Completion: 2021-06-09
• Last Update Posted: 13 June 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 17

Inclusion Criteria

1.Moderate (depressions appear spontaneously when standing and not lying down) or severe (depressions appear spontaneously when standing and lying down) cellulite in the thighs and/or buttocks
2.BMI less than 30
3.Caucasian
4.Fluency in both written and spoken English
5.Negative urine pregnancy test
6.Will not try any other cellulite procedures through the follow-up period
7.Participants of the previously conducted Contour-0001 study will be permitted to be enrolled provided they have exited the Contour-0001 study already.

Exclusion Criteria

1.Contour-0001 or Contour-0002 cellulite procedure on the thighs or buttocks in the last 3 months
2.Any non-Contour System procedure on thighs or buttocks to treat cellulite (for example, Cellfina)
3.Prior liposuction in the thighs or buttocks
4.Greater than 10% increase or decrease in body weight within the last six months or history of greater than 60 kilograms weight loss
5.Evidence of an active infection or fever greater than 38oC
6.Current or recent smoker (within 6 months)
7.History of hypertension, diabetes or hypoglycemia
8.Non-Caucasian
9.Pregnant or breast feeding
10.History of coagulopathy(ies) or pneumopathy
11.History of severe anemia
12.Has atrophic scars, or a history of atrophic scars or keloids
13.Taken within 14 days of procedure:
a.NSAIDs (e.g., aspirin, ibuprofen, naproxen)
b.Vitamin E, herbal teas or dietary supplements (e.g., Gingko Biloba, Willow Bark)
14.Any known factor, condition or disease that in the opinion of the physician might interfere with procedure compliance, study conduct or interpretation of the results such as skin laxity, co-existent psychiatric disease, history of noncompliance to medical regimens, or unwillingness to comply with study requirements

Study & Design

• Study Type: Interventional
• Study Design: Not specified