A Study to Evaluate the Efficacy of ELAPR002f in Females and Males With Atrophic Acne Scars

NCT03056235 | Completed

• 1 other identifier: ELAPR-P1D
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atrophic Acne Scar

Keywords

Atrophic acne scar

Outcome Measures

Primary Outcomes (1)

• Measurement of the dimensions of acne scars pre and post treatment

  The volume of acne scar depressions within the treatment field will be measured using 2D and 3D camera analysis

  6 months

Secondary Outcomes (1)

• Assessment of product integration into dermal tissue using histological analysis

  6 months

Study Arms (2)

ELAPR002f

EXPERIMENTAL

ELAPR002f is a tropoelastin gel cross-linked with derivatised hyaluronic acid

Device: ELAPR002f

Saline control

PLACEBO COMPARATOR

Saline

Device: Saline

Interventions

ELAPR002f DEVICE

30mg/ml Tropoelastin cross-linked with derivatised hyaluronic acid

ELAPR002f

Saline DEVICE

Saline control

Saline control

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female/male subjects with matched treatment fields of approximately 2cm x 2cm on each side of the face on the temples or cheek bones that each contain a minimum of two rolling atrophic acne scars that are distensible when stretched between one's fingers and that are classified as moderate to severe on the scales detailed at Appendix 2.
• Acne scars in areas of otherwise normal healthy skin.
• Age: 18 - 55 years.
• Capable of providing voluntary informed consent.
• Good general health.
• Female subjects who are sexually active will be of non-child bearing potential (i.e., surgically sterilized or postmenopausal), abstain from sexual intercourse, or use a reliable method of contraception (e.g. hormonal contraceptive, condom, IUD) for at least 30 days prior to dosing and during the duration of the study.
• Fitzpatrick skin types I, II, III, IV or V.

You may not qualify if:

• No active ongoing acne lesions on the face (or back and torso for the subjects who will also receive treatment in these areas).
• Subjects who present with predominantly ice pick or box scars.
• Current or previous treatment of atrophic acne scars with fillers, lasers, or deep chemical peels which reach the dermis, or any other medical or surgical treatment which in the investigators opinion could reasonably be deemed to impact on the results of the current clinical study.
• Known hypersensitivity to tropoelastin, hyaluronic acid or any other component of ELAPR002f or ELAPR002g.
• Female subjects with a positive pregnancy test, women refusing to agree to adequate contraception and pregnancy tests during the study, or women who are planning to become pregnant during the period of the trial.
• Participation in a clinical trial of a pharmacological agent within 1 month prior to screening.
• Clinically significant haematology or biochemistry findings at screening.
• Positive test for hepatitis B, hepatitis C or HIV at screening.
• Bleeding diathesis, anticoagulant drugs, thrombocytopenia or clinically significant prolonged APTT or PT.
• Chronic use of aspirin, other non-steroidal anti-inflammatory drugs or other anti-platelet agents.
• History of keloid formation.
• History of granulomatous or connective tissue disease.
• Systemic corticosteroids within last 12 weeks.
• Currently using topical retinoids, or have used topical retinoids in the past 8 weeks.
• Diabetes or other metabolic disorders that may interfere with the subject's response to treatment in the opinion of the investigator.

Sponsors & Collaborators

• Elastagen Pty Ltd: lead

Study Sites (1)

Hammersmith Medicines Research

London, Greater London, NW10 7EW, United Kingdom

Location

Study Officials

• Frans Van den Berg, Doctor

  Hammersmith Medical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2017
• First Posted: February 17, 2017
• Study Start: March 27, 2017
• Primary Completion: March 23, 2018
• Study Completion: September 11, 2018
• Last Updated: September 28, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)