NCT00510055

Brief Summary

The primary objective of this study is to look at the efficacy of subdermal manipulation and filler injection in the improvement of acne scar appearance.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 31, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 1, 2007

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

December 2, 2021

Status Verified

November 1, 2021

Enrollment Period

2.1 years

First QC Date

July 31, 2007

Last Update Submit

November 30, 2021

Conditions

Acne Scarring

Outcome Measures

Primary Outcomes (1)

  • Scar Improvement

    3.5 months

Secondary Outcomes (1)

  • Adverse Events

    3.5 months

Study Arms (2)

A

EXPERIMENTAL

scars receive subdermal manipulation ONLY

Procedure: subdermal manipulation ONLY

B

EXPERIMENTAL

scars receive subdermal manipulation AND injection of a filler

Procedure: subdermal manipulation AND injection of a filler

Interventions

subdermal manipulation ONLYPROCEDURE

scars receive subdermal manipulation ONLY

Also known as: subcision
A
subdermal manipulation AND injection of a fillerPROCEDURE

scars receive subdermal manipulation AND injection of a filler

Also known as: Radiesse
B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 and over
  • Have two acne scar areas
  • The subjects are in good health
  • The subject has the willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator.

You may not qualify if:

  • Under 18 years of age
  • Pregnancy or Lactation
  • Subjects who are unable to understand the protocol or to give informed consent
  • Subjects with mental illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University Feinberg School of Medicine, Department of Dermatology

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Interventions

Prolaryn Plus

Study Officials

  • Murad Alam, MD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor in Dermatology, Otolaryngology- Head and Neck Surgery, and Surgery-Organ Transplantation

Study Record Dates

First Submitted

July 31, 2007

First Posted

August 1, 2007

Study Start

June 1, 2007

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

December 2, 2021

Record last verified: 2021-11

Locations

US(1)