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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 21, 2014