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

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00795327

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 IV

MedlinePlus related topics: Acne Scars

Drug Information available for: Lactic acid Ammonium lactate Poly-L-lactic acid

U.S. FDA Resources

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

Further study details as provided by Sanofi-Aventis:

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 ]

Estimated Enrollment:	25
Study Start Date:	October 2008
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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

Contacts

Contact: Public Registry GMA

publiregistrygma@sanofi-aventis.com

Locations

Canada
Sanofi-Aventis	Recruiting
Quebec, Canada

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Chair:

Mary Tzortzis

Sanofi-Aventis Canada Inc.

More Information

Responsible Party:	sanofi-aventis ( Medical Affairs Study Director )
Study ID Numbers:	POLYL_L_02508
Study First Received:	November 20, 2008
Last Updated:	November 20, 2008
ClinicalTrials.gov Identifier:	NCT00795327
Health Authority:	Canada: Ethics Review Committee

Study placed in the following topic categories:

Exanthema
Facial Dermatoses
Facies
Skin Diseases

Sebaceous Gland Diseases
Acne Vulgaris
Cicatrix

Additional relevant MeSH terms:

Acneiform Eruptions

ClinicalTrials.gov processed this record on January 14, 2009