Status:
COMPLETED
Injectable POLY-L-Lactic Acid for Treatment of Hill and Valley Acne Scarring
Lead Sponsor:
Bausch Health Americas, Inc.
Conditions:
Acne Vulgaris
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
Eligibility Criteria
Inclusion
- Outpatient seeking therapy for correction of hill and valley acne scarring.
- Ability and willingness to understand and comply with requirements of the trial
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00795327
Start Date
October 1 2008
End Date
September 1 2009
Last Update
November 20 2019
Active Locations (1)
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1
Sanofi-Aventis Administrative Office
Laval, Canada