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

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Sculptra (Poly-L-Lactic Acid Dermal Implant)
Sponsored by
Bausch Health Americas, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sanofi-Aventis Administrative Office

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

single arm study

Outcomes

Primary Outcome Measures

Physician Scar Improvement Scale (PSIS)
Self-Assessed Scar Improvement Scale (SASIS).

Secondary Outcome Measures

Degree of subject satisfaction with treatment
Adverse events

Full Information

First Posted
November 20, 2008
Last Updated
November 18, 2019
Sponsor
Bausch Health Americas, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00795327
Brief Title
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

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch Health Americas, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
single arm study
Intervention Type
Device
Intervention Name(s)
Sculptra (Poly-L-Lactic Acid Dermal Implant)
Intervention Description
Drug Device study
Primary Outcome Measure Information:
Title
Physician Scar Improvement Scale (PSIS)
Time Frame
At each visit
Title
Self-Assessed Scar Improvement Scale (SASIS).
Time Frame
At each visit
Secondary Outcome Measure Information:
Title
Degree of subject satisfaction with treatment
Time Frame
At each Visit
Title
Adverse events
Time Frame
At each visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Tzortzis
Organizational Affiliation
Sanofi-Aventis Canada Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Sanofi-Aventis Administrative Office
City
Laval
Country
Canada

12. IPD Sharing Statement

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

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