Collagen Injections for the Treatment of Acne Scars and W... | NCT01704209

Studies
Collagen Injections for the Treatment of Acne Scars and Wrinkles

NCT01704209

Sponsor

Northwestern University

Status

Terminated

Last Update Posted

Dec 6, 2021Actual

Enrollment

4Actual

Phase

Phase 1

Conditions

Acne Scars
Wrinkles

Interventions

Fibroblast Treatment
Vehicle

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

Dec 2021

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Company stopped making product for cosmetic use. All consented subjects withdrew before any study interventions were performed.

Expanded Access Info

Start Date

Apr 2013

Primary Completion Date

Jun 2013Actual

Completion Date

Jun 2013Actual

First Submitted Date

Sep 27, 2012

First Submission Date that Met QC Criteria

Oct 9, 2012

First Posted Date

Oct 11, 2012Estimated

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

Dec 2, 2021

Last Update Posted Date

Dec 6, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

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

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

4Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Fibroblast Treatment	Experimental	The fibroblast treatment will be randomly injected into one side of the face.	Drug: Fibroblast Treatment
Vehicle	Placebo Comparator	The vehicle will be injected randomly to the other side of the face.	Procedure: Vehicle

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fibroblast Treatment	Drug		Fibroblast Treatment
Vehicle

Measure	Description	Time Frame
Change from baseline of rater's comparisons at 6 months		Basline and 6 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18 or over
Bilateral acne scars or have moderate to severe wrinkles
Subjects in good health
Subjects 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
recent Accutane use in the past 6 months
prone to hypertrophic and keloidal scarring
have excessively redundant skin in the treatment area or wrinkles longer than 20 cm total
have a history of autoimmune disorders, organ transplantation, cancer not in remission, active or chronic skin disease
have a history of basal-cell carcinoma
have previously received autologous fibroblast treatment
have undergone any confounding therapy in the lower two-thirds of the face within 1 year or any investigational treatment within 30 days.
have an allergy to collagen, bovine products, local anesthetics, gentamicin, or amphotericin B
subjects who are unable to understand the protocol or to give informed consent
subjects with mental illness

Accepts Healthy Volunteers

Yes

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