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

NCT ID: NCT00795327

Last Updated: 2019-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2009-09-30

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.

Conditions

Acne Vulgaris

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

single arm study

Group Type: EXPERIMENTAL

Sculptra (Poly-L-Lactic Acid Dermal Implant)

Intervention Type: DEVICE

Drug Device study

Interventions

Sculptra (Poly-L-Lactic Acid Dermal Implant)

Drug Device study

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bausch Health Americas, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mary Tzortzis

Role: STUDY_CHAIR

Sanofi-Aventis Canada Inc.

Locations

Sanofi-Aventis Administrative Office

Laval, , Canada

Countries

Canada

Other Identifiers

POLYL_L_02508

Identifier Type: -

Identifier Source: org_study_id