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

Not Applicable

Completed

• Conditions: Acne Vulgaris
• Interventions: Device: Sculptra (Poly-L-Lactic Acid Dermal Implant)

• Registration Number: NCT00795327
• Lead Sponsor: Bausch Health Americas, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-11-20
• Study First Submitted QC: 2008-11-20
• Study First Posted: 2008-11-21
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-18
• Last Update Posted: 2019-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Sculptra (Poly-L-Lactic Acid Dermal Implant)	single arm study

Primary Outcome Measures

Name	Time	Method
Physician Scar Improvement Scale (PSIS)	At each visit
Self-Assessed Scar Improvement Scale (SASIS).	At each visit

Secondary Outcome Measures

Name	Time	Method
Degree of subject satisfaction with treatment	At each Visit
Adverse events	At each visit

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇨🇦 Laval, Canada