A Study to Evaluate the Efficacy of ELAPR002f and ELAPR002g in Females and Males With Atrophic Acne Scars
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Outcomes Assessor
Primary Purpose: Treatment
|Official Title:||A Randomized, Within-subject, Placebo-controlled, Single-blind Study to Evaluate the Efficacy of ELAPR002f and ELAPR002g in Females and Males With Atrophic Acne Scars|
- Measurement of the dimensions of acne scars pre and post treatment [ Time Frame: 6 months ]The volume of acne scar depressions within the treatment field will be measured using 3D camera analysis
- Assessment of product integration into dermal tissue using histological analysis [ Time Frame: 6 months ]Subjects who receive treatments to acne scars on the torso will undergo biopsy and the tissue analysed using histology techniques. The level of product persisting in the dermis will be assessed as a score out of 5 and dermal and epidermal thickness measured pre and post treatment.
|Study Start Date:||December 2016|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||August 2017 (Final data collection date for primary outcome measure)|
ELAPR002f is a tropoelastin gel cross-linked with derivatised hyaluronic acid
30mg/ml Tropoelastin cross-linked with derivatised hyaluronic acid
ELAPR002g is a tropoelastin gel cross-linked with derivatised hyaluronic acid
40mg/ml Tropoelastin cross-linked with derivatised hyaluronic acid
Placebo Comparator: Saline control
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 or ELAPR002g 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 or ELAPR002g 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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT03056235
|Contact: Robert Daniels, PhD||+61 9209 email@example.com|
|Contact: Emma McGilly, BSc||+61 9209 firstname.lastname@example.org|
|Hammersmith Medicines Research||Recruiting|
|London, Greater London, United Kingdom, NW10 7EW|
|Contact: Frans van den Berg, MD 020 89614130 email@example.com|