NCT03407313

CONFORM: Rotational Fractional Resection for Submental Contouring

Completed NA Results posted Last updated 3 February 2021

What this trial tests

NA trial testing Rotational fractional resection (1.5mm diameter device) in Skin Laxity in 68 participants. Completed in 23 April 2019.

Timeline

8 January 2018

Primary endpoint
28 December 2018

23 April 2019

Quick facts

Lead sponsor	Recros Medica, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	68
Start date	8 January 2018
Primary completion	28 December 2018
Estimated completion	23 April 2019
Sites	6 locations across United States

Drugs / interventions tested

• Rotational fractional resection (1.5mm diameter device)

Conditions studied

• Skin Laxity — all drugs for Skin Laxity →
• Lipodystrophy — all drugs for Lipodystrophy →

Sponsor

Recros Medica, Inc.

Who can join

30 and older, any sex, with Skin Laxity or Lipodystrophy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With a Reduction of Submental Skin Area ≥ 20 mm^2 Primary · Baseline and 90 days post treatment

This endpoint is the difference in the measurement of submental skin area (mm\^2) between Baseline and 90 days. A reduction of ≥ 20 mm\^2 denotes improvement.

Group	Value	95% CI
Rotational Fractional Resection (1.5mm Diameter Device)	49

Number of Participants Who Were Satisfied With the Appearance of Their Neck and Jawline Secondary · 90 days after treatment

Subjects rated their satisfaction of the appearance of their neck and jawline on a Subject Satisfaction Questionnaire. Results reflect subjects who were satisfied ("somewhat satisfied", "satisfied", or "very satisfied").

Group	Value	95% CI
Rotational Fractional Resection (1.5mm Diameter Device)	56

Number of Participants With Post-treatment Images Correctly Identified Secondary · Pre-treatment and 90 days after treatment

Correct identification of post-treatment images by three blinded independent reviewers in more than 50% of subjects

Blinded Reviewer 1

Group	Value	95% CI
Rotational Fractional Resection (1.5mm Diameter Device)	59

Blinded Reviewer 2

Group	Value	95% CI
Rotational Fractional Resection (1.5mm Diameter Device)	67

Blinded Reviewer 3

Group	Value	95% CI
Rotational Fractional Resection (1.5mm Diameter Device)	67

Adverse events — posted to ClinicalTrials.gov

Time frame: 180 days. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Rotational Fractional Resection (1.5mm Diameter Device)

Serious: 0/68 (0%)

Deaths: 0/68

Other adverse events (7 terms — click to expand)

Reaction	System	Rotational Fractional Rese…
Administration site erythema	Injury, poisoning and procedural complications	—
Administration site bruising	Injury, poisoning and procedural complications	—
Abnormal Skin Texture	Injury, poisoning and procedural complications	—
Skin Mass	Skin and subcutaneous tissue disorders	—
Contact Dermatitis	Injury, poisoning and procedural complications	—
Hypoaesthesia	Injury, poisoning and procedural complications	—
Nausea	Gastrointestinal disorders	—

Data from ClinicalTrials.gov NCT03407313 adverse events section.

Sponsor's own description

This study will evaluate the safety and efficacy of rotational fractional resection (RFR) to improve neck contouring. RFR is used to remove loose skin and fat.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.