Condition(s) treated: Jowls

Intervention: Calcium Hydroxylapatite injection (Device)

Phase: Phase 3

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:
Richard Huggins, MD, Phone: 312-695-0287, Email: r-huggins@northwestern.edu

The objective of this study is to determine whether injectable filler into wrinkles can result in safe, aesthetically pleasing, and long-lasting correction of these.

Official title: An Evaluation of an Injectable Material for Correction of Wrinkles

Study design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Primary outcome: Correction of Wrinkles (Time Frame: 9 Months)

Detailed description: The purpose of this study is to determine whether injectable filler into wrinkles can result in safe, aesthetically pleasing, and long-lasting correction of these.

Minimum eligible age: 40 Years. Maximum eligible age: 65 Years. Eligible gender(s): Both.

Criteria:

Inclusion Criteria:

- Age 40-65

- Have wrinkles

- The subjects are in good health.

- The subject has willingness and the ability to understand and provide informed consent

for the use of their tissue and communicate with the investigator.

Exclusion Criteria:

- Subjects who have received within the past 3 months or are planning to receive in the

next 6 months, botulinum toxin injections for correction of wrinkles.

- Subjects who have received within the past one year any soft tissue augmentation

material into the chin and experimental area (defined as any area on the face below the lower lip vermilion, excluding the lateral lip marionette line up to 1 cm below this level).

- Subjects with prior history of nodule formation or hypersensitivity reactions to

lidocaine or medium-term augmentation materials, including hyaluronic acid derivatives, poly-L-lactic acid, and calcium hydroxylapatite.

- Subjects who are currently using anticoagulation therapy.

- Subjects who have a history of bleeding disorders.

- Subjects who are unable to understand the protocol or to give informed consent.

- Subjects with mental illness.

Richard Huggins, MD, Phone: 312-695-0287, Email: r-huggins@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
Rania Majzoub, MD, Sub-Investigator
Lucile White, MD, Sub-Investigator
Susan Lai, MD, Sub-Investigator
Dennis West, PhD, Sub-Investigator
Richard Huggins, MD, Sub-Investigator

Start date: July 2007
End date: September 2008
Last updated: April 25, 2008

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