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

NCT00795327 | Completed

• 1 other identifier: POLYL_L_02508
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Physician Scar Improvement Scale (PSIS)

  At each visit

• Self-Assessed Scar Improvement Scale (SASIS).

  At each visit

Secondary Outcomes (2)

• Degree of subject satisfaction with treatment

  At each Visit

• Adverse events

  At each visit

Study Arms (1)

1

EXPERIMENTAL

single arm study

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

Interventions

Sculptra (Poly-L-Lactic Acid Dermal Implant) DEVICE

Drug Device study

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Outpatient seeking therapy for correction of hill and valley acne scarring.
• Ability and willingness to understand and comply with requirements of the trial

You may not qualify if:

• 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

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead

Study Sites (1)

Sanofi-Aventis Administrative Office

Laval, Canada

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Officials

• Mary Tzortzis

  Sanofi-Aventis Canada Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2008
• First Posted: November 21, 2008
• Study Start: October 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: November 20, 2019

Record last verified: 2019-11

Locations

CA (1)