Clinical trial NCT00795327: Injectable POLY-L-Lactic Acid for Treatment of Hill and Valley Acne Scarring
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acne Vulgaris
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2008-11-21
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 events with Poly-L-Lactic Acid(Sculptra) therapy.


Eligibility 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.

Primary outcomes:
measure: Physician Scar Improvement Scale (PSIS)
timeFrame: At each visit
measure: Self-Assessed Scar Improvement Scale (SASIS).
timeFrame: At each visit
Secondary outcomes:
measure: Degree of subject satisfaction with treatment
timeFrame: At each Visit
measure: Adverse events
timeFrame: At each visit
Other outcomes:
Locations:
city: Laval
country: Canada
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi-Aventis Canada Inc.
name: Mary Tzortzis
role: STUDY_CHAIR
References: