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

Study Overview
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Brief Summary
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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.

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

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Device: Sculptra (Poly-L-Lactic Acid Dermal Implant)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>single arm study | Device: Sculptra (Poly-L-Lactic Acid Dermal Implant)<br>* Drug Device study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician Scar Improvement Scale (PSIS) |  | At each visit | 
| Self-Assessed Scar Improvement Scale (SASIS). |  | At each visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of subject satisfaction with treatment |  | At each Visit | 
| Adverse events |  | At each visit |