Official Title: “The Canadian Study of the Use of Injectable Poly-L-Lactic Acid Dermal Implant for the Treatment of Hill and Valley Acne Scarring”

Primary:

Evaluate the degree of correction attainable with Poly-L-Lactic Acid(Sculptra) for the correction of hill and valley acne scarring

Secondary:

Document types and incidence of device adverse events with Poly-L-Lactic Acid(Sculptra) therapy.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: August 2009

Intervention(s) in this Clinical Trial

• Device: Sculptra (Poly-L-Lactic Acid Dermal Implant)
  • Drug Device study

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • single arm study

Primary Measures

• Physician Scar Improvement Scale (PSIS)
  • Time Frame: At each visit
    Safety Issue?: No
• Self-Assessed Scar Improvement Scale (SASIS).
  • Time Frame: At each visit
    Safety Issue?: No

Secondary Measures

• Degree of subject satisfaction with treatment
  • Time Frame: At each Visit
    Safety Issue?: No
• Adverse events
  • Time Frame: At each visit
    Safety Issue?: No

Inclusion Criteria:

• Outpatient seeking therapy for correction of hill and valley acne scarring.
• Ability and willingness to understand and comply with requirements of the trial

Exclusion Criteria:

• The subject has active acne or chronic skin disease, inflammation or related conditions, such as infection, psoriasis and herpes zoster
• History of presence of keloid formation or hypertrophic scars
• History of procedures that precipitate an active dermal inflammatory or hyperplastic response (i.e., epilation or radiofrequency laser and chemical peeling procedures) within one month of study entry
• History of use of facial tissue augmenting therapy or aesthetic facial surgical therapy within six months prior to study entry
• Concomitant anticoagulant therapy, antiplatelet therapy or has any bleeding disorders
• History of unanticipated adverse reactions when treated with hyaluronic acid based products
• Any condition which in the opinion of the investigator makes the patient unable to complete the study per protocol (e.g., patients not likely to avoid other facial cosmetic treatments; patients not likely to stay in the study for its duration because of other commitments, concomitant conditions, or past history; patients anticipated to be unreliable, or patients who have a concomitant condition that may develop symptoms that might confuse or confound study treatments or assessments)
• History of or current cancerous or pre-cancerous lesions in the area to be treated
• Use of any investigational drugs or any other medical devices within 30 days of enrolment
• Use of any prohibited medication within a proscribed time period before entry
• Pregnancy
• Recent use of Accutane (patient should not be on Accutane for the last 6 months)
• History of allergic/anaphylactic reactions, including hypersensitivity to local anaesthetics (lidocaine)
• Recent history of trauma in the face (less that 1 year)
• Previous of Dermalive or Dermadeep
• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Sanofi-Aventis

Overall Clinical Trial Officials and Contacts

Mary Tzortzis Study Chair Sanofi-Aventis Canada Inc.  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00795327

Study ID Number: POLYL_L_02508

ClinicalTrials.gov Identifier: NCT00795327

Health Authority: Canada: Ethics Review Committee