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Injectable POLY-L-Lactic Acid for Treatment of Hill and Valley Acne Scarring

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00795327
First received: November 20, 2008
Last updated: October 1, 2010
Last verified: October 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Acne Vulgaris
 Device: Sculptra (Poly-L-Lactic Acid Dermal Implant)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Acne Scars
U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Physician Scar Improvement Scale (PSIS) [ Time Frame: At each visit ] [ Designated as safety issue: No ]
  • Self-Assessed Scar Improvement Scale (SASIS). [ Time Frame: At each visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Degree of subject satisfaction with treatment [ Time Frame: At each Visit ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: At each visit ] [ Designated as safety issue: No ]

Enrollment: 22
Study Start Date: October 2008
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
single arm study
 Device: Sculptra (Poly-L-Lactic Acid Dermal Implant)
Drug Device study

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00795327

Locations
Canada
Sanofi-Aventis Administrative Office
Laval, Canada
Sponsors and Collaborators
Sanofi
Investigators
Study Chair: Mary Tzortzis Sanofi-Aventis Canada Inc.
  More Information

No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00795327     History of Changes
Other Study ID Numbers: POLYL_L_02508
Study First Received: November 20, 2008
Last Updated: October 1, 2010
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Acne Vulgaris
Cicatrix
Acneiform Eruptions
Skin Diseases
 Facial Dermatoses
Sebaceous Gland Diseases
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013