A Study to Evaluate the Efficacy of ELAPR002f in Females and Males With Atrophic Acne Scars
Condition: Atrophic Acne Scar
MeSH terms: Atrophy
Study type: Interventional

Summary: 
      The study is designed to evaluate the efficacy of two formulations of a cross-linked
      tropoelastin matrix given the product codes ELAPR002f (collectively referred to as ELAPR or
      ELAPR002) for the treatment of rolling atrophic acne scars when administered as intradermal
      implants.
    

Detailed description: 
      The study consists of a pre-screen visit followed by seven study visits. There will be a
      pre-screen visit where up to 30 potential study subjects will have 2D and 3D photographs
      taken of the candidate treatment fields to enable the Sponsor and Trial Centre staff to set
      practical guidelines for subject recruitment based on example atrophic acne scar images and
      published acne scar assessment scales. Subjects participating in the pre-screen period may be
      invited to participate in the full study if they are considered to be able to meet the
      eligibility criteria.

      There will be a screening visit to confirm eligibility and to assess baseline parameters
      (D-28 to D-1). In addition, the proposed treatment fields on each side of the face will be
      selected at screening and recorded with 2D & 3D photographs and their location marked in
      detail on acetate sheets.

      For enrolled subjects there will be three intradermal (i.d.) treatment sessions of ELAPR002f
      and placebo, given at one-monthly intervals (approximately D0, D28 and D56). The treatment at
      D0 will be administered so as to reduce the appearance of the atrophic rolling acne scars in
      the treatment field relative to the surrounding skin. The treatments at D28 and D56 will be
      given to optimise the treatment outcome and to minimise the appearance of the atrophic
      rolling acne scars in the treatment field.

      In addition to the facial acne scars, a minimum of 5 subjects in each treatment group will
      also receive treatment on two moderate to severe, distensible, rolling acne scars present
      approximately 5-10cm apart on the back or torso.

      There will be an assessment visit 14 and 84 days after the first treatment session (D14 and
      D84) to review any adverse events and assess the implant sites.

      ELAPR002f will be administered alone vs. placebo. Subjects will be followed for a total of 24
      weeks (to D168) following the first treatment, with efficacy and safety assessments
      undertaken at each study visit. At the final follow-up visit (D168) a biopsy sample will be
      taken from of each of the treated atrophic acne scars on the back or torso (active and
      placebo treated) from those subjects who received treatment to scars on the back or torso.

      Each study subject will act as their own control with active and placebo treatments given
      single-blind to treatment fields on contralateral sides of the face. Prior to administration
      the selected treatment fields will be identified and marked with a washable marker using the
      2D and 3D images and acetate sheets created at the screening visit to ensure consistency of
      anatomic sites for treatment (and biopsy for those subjects receiving treatment to the back
      or torso). Follow-up period extended to D336.
    

Intervention name(s): ELAPR002f; Saline
Intervention type(s): Device; Device
Intervention description(s): 30mg/ml Tropoelastin cross-linked with derivatised hyaluronic acid; Saline control
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Atrophic acne scar