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

Acne Vulgaris Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00795327
• Other study ID #: POLYL_L_02508
• Status: Completed
• Phase: N/A
• Start date: October 2008
• Est. completion date: September 2009

Study information

• Verified date: November 2019
• Source: Bausch Health Americas, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Device:
• Sculptra (Poly-L-Lactic Acid Dermal Implant)
Drug Device study

Locations

Country	Name	City	State
Canada	Sanofi-Aventis Administrative Office	Laval

Sponsors (1)

Lead Sponsor	Collaborator
Bausch Health Americas, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physician Scar Improvement Scale (PSIS)		At each visit
Primary	Self-Assessed Scar Improvement Scale (SASIS).		At each visit
Secondary	Degree of subject satisfaction with treatment		At each Visit
Secondary	Adverse events		At each visit