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Completed

NCT Number: NCT00869687

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

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.

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Key information

Conditions

Healthy Volunteers

Age range

35 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sanofi-Aventis Administrative Office

Laval, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Poly-L-Lactic Acid Injection

Device

0.05 mL of poly-l-lactic acid will be injected as depot at three (3) points (a total of 0.15 mL).

Primary outcomes

  1. Biopsies change from baseline to 6 months after first Sculptra injection in level of Type 1 collagen.

    Time frame: 6 months

Secondary outcomes

  1. Change from baseline in level of Type 1 collagen at 3 months and 12 months

    Time frame: 3 and 12 months

  2. Change from baseline in level of Type III collagen at 3 months, 6 months, & 12 months by immunohistochemistry in a central laboratory.

    Time frame: 3, 6, and 12 months

  3. Qualitative assessment in degree of change from baseline in Type I collagen at 3 months, 6 months, & 12 months by a pathologist.

    Time frame: 3, 6, and 12 months

  4. Degree of inflammation assessed by histology at 3 months, 6 months, and 12 months.

    Time frame: 3, 6, and 12 months

  5. Qualitative assessment in degree of change from baseline in Type III collagen at 3 months, 6 months, & 12 months by a pathologist.

    Time frame: 3, 6, and 12 months

Sponsors and collaborators

Lead sponsor

Bausch Health Americas, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Mar 26, 2009
Registry last updated
Nov 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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