Biopsy Study for Sculptra (Poly-L-Lactic Acid)

Healthy Volunteers Clinical Trial

Official title:

A Single Group Study for the Characterization of Human Tissue Response to Injectable Poly-L-Lactic Acid (Sculptra) in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00869687
• Other study ID #: POLYL_L_02888
• Status: Completed
• Phase: N/A
• Start date: March 2009
• Est. completion date: May 2010

Study information

• Verified date: November 2019
• Source: Bausch Health Americas, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study involves research to evaluate new collagen (the elastic fibers that provide skin with its strength and resilience) formation in the skin following injections of Sculptra (Poly-L-Lactic Acid or PLLA). The secondary objectives of the study are to better understand the human skin responses to Sculptra and to assess the safety of Sculptra injections.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 55 Years

Eligibility

Inclusion Criteria:

• If female, the subject must use appropriate form of birth control.

Exclusion Criteria:

• History of allergies or an allergic reaction to local numbing medications (e.g., lidocaine, etc.), latex, or silicone.

• History of forming large scars following an accident or surgery.

• History of any bleeding problems.

• Redness, swelling, or signs of infection behind the right or left ear between the area of the earlobe and hairline.

• Pimples, rashes, scarring or any other skin changes behind the right or left ear between the area of the earlobe and hairline.

• History of any medical problems (for example, heart attack, stroke, diabetes/high blood sugar, hepatitis, human immunodeficiency virus (HIV), severe asthma, rheumatoid arthritis, emphysema, breathing problems). Subjects with high blood pressure or high cholesterol may qualify for the study if there have been no changes in their medications for three (3) months.

• History of cancer within five (5) years.

• Previous cosmetic surgery or cosmetic procedures affecting the area behind the ear.

• Subject who plans to have any facial or ear surgery within the next year.

• History of alcohol or drug abuse.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Device:
• Poly-L-Lactic Acid Injection
0.05 mL of poly-l-lactic acid will be injected as depot at three (3) points (a total of 0.15 mL).

Locations

Country	Name	City	State
Canada	Sanofi-Aventis Administrative Office	Laval

Sponsors (1)

Lead Sponsor	Collaborator
Bausch Health Americas, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biopsies change from baseline to 6 months after first Sculptra injection in level of Type 1 collagen.		6 months
Secondary	Change from baseline in level of Type 1 collagen at 3 months and 12 months		3 and 12 months
Secondary	Change from baseline in level of Type III collagen at 3 months, 6 months, & 12 months by immunohistochemistry in a central laboratory.		3, 6, and 12 months
Secondary	Qualitative assessment in degree of change from baseline in Type I collagen at 3 months, 6 months, & 12 months by a pathologist.		3, 6, and 12 months
Secondary	Degree of inflammation assessed by histology at 3 months, 6 months, and 12 months.		3, 6, and 12 months
Secondary	Qualitative assessment in degree of change from baseline in Type III collagen at 3 months, 6 months, & 12 months by a pathologist.		3, 6, and 12 months