Condition(s) treated: Acne Scarring

Intervention: Subdermal Manipulation (Procedure); Calcium Hydroxylapatite (Drug)

Phase: Phase 4

Enrollment status: Recruiting

Sponsor: Northwestern University

Principal investigator(s) or official(s):
Murad Alam, MD, Principal Investigator, Affiliation: Northwestern University, Feinberg School of Medicine, Department of Dermatology

Overall contact:
Nicolle Martin, MD, Phone: 312-695-0281, Email: nicolle-martin@northwestern.edu

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

We hypothesize that subdermal manipulation with an injectable filler would be efficacious in improving scar appearance due to new collagen formation.

Official title: Treatment of Acne Scarring With Subdermal Manipulation

Study design: Treatment, Randomized, Single Blind, Active Control, Single Group Assignment, Efficacy Study

Primary outcome: Scar Improvement (Time Frame: 3.5 months)

Secondary outcome: Adverse Events (Time Frame: 3.5 months)

Detailed description: The primary objective of this study is to look at the efficacy of subdermal manipulation in the improvement of acne scar appearance.

We hypothesize that subdermal manipulation with an injectable filler will be efficacious in improving scar appearance due to new collagen formation.

Minimum eligible age: 18 Years. Eligible gender(s): Both.

Criteria:

Inclusion Criteria:

- Age 18 and over

- Have two acne scars

- 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

Nicolle Martin, MD, Phone: 312-695-0281, Email: nicolle-martin@northwestern.edu

Northwestern University, Feinberg School of Medicine, Department of Dermatology, Chicago, Illinois 60611, United States; Recruiting
Richard Huggins, MD, Phone: 312-695-0287, Email: r-huggins@northwestern.edu
Murad Alam, MD, Principal Investigator
Nicolle Martin, MD, Sub-Investigator
Jessica Newman, MD, Sub-Investigator
Dennis West, PhD, Sub-Investigator
Lucille White, MD, Sub-Investigator
Susan Boone, MD, Sub-Investigator
Simon Yoo, MD, Sub-Investigator

Start date: June 2007
Last updated: July 31, 2007

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