Treatment of Acne Scarring With a Novel Procedure Combina... | NCT00510055

Studies
Treatment of Acne Scarring With a Novel Procedure Combination

NCT00510055

Sponsor

Northwestern University

Status

Completed

Last Update Posted

Dec 2, 2021Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Acne Scarring

Interventions

subdermal manipulation ONLY
subdermal manipulation AND injection of a filler

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2007

Primary Completion Date

Jul 2009Actual

Completion Date

Jul 2009Actual

First Submitted Date

Jul 31, 2007

First Submission Date that Met QC Criteria

Jul 31, 2007

First Posted Date

Aug 1, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 30, 2021

Last Update Posted Date

Dec 2, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Murad Alam, Professor in Dermatology, Otolaryngology- Head and Neck Surgery, and Surgery-Organ Transplantation, Northwestern UniversityPrincipal Investigator

Lead Sponsor

Northwestern UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

The primary objective of this study is to determine whether the use of subcision in conjunction with calcium hydroxylapatite injections will improve the appearance of rolling acne scars better than subcision alone.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
subdermal manipulation ONLY	Procedure	scars receive subdermal manipulation ONLY	A

Measure	Description	Time Frame
Scar Improvement		3.5 months

Measure	Description	Time Frame
Adverse Events		3.5 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Murad Alam, MD	Northwestern University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Northwestern University Feinberg School of Medicine, Department of Dermatology		Chicago	Illinois	60611	United States

Intervention Browse Module

MeSH Terms

ID	Term
C000618322	Prolaryn Plus

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided