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

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Bausch Health

Status

Completed

Conditions

Acne Vulgaris

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT00795327
POLYL_L_02508

Details and patient eligibility

About

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.

Enrollment

22 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

22 participants in 1 patient group

1
Experimental group
Description:
single arm study
Treatment:
Device: Sculptra (Poly-L-Lactic Acid Dermal Implant)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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