Acne Vulgaris
Conditions
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.
Interventions
DEVICESculptra (Poly-L-Lactic Acid Dermal Implant)
Drug Device study
Sponsors
Bausch Health Americas, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Physician Scar Improvement Scale (PSIS) | At each visit |
| Self-Assessed Scar Improvement Scale (SASIS). | At each visit |
Secondary
| Measure | Time frame |
|---|---|
| Degree of subject satisfaction with treatment | At each Visit |
| Adverse events | At each visit |
Countries
Canada
Outcome results
None listed