A Study to Evaluate the Efficacy of ELAPR in Women With Striae Distensae Alba

NCT02510768 | Completed Phase 1

• 1 other identifier: ELAPR-P1C
• Study Type: interventional
• Target: 26
• 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 and ELAPR002g (collectively referred to as ELAPR or ELAPR002) for the treatment of Striae Distensae (SD) alba when administered as intradermal implants.

Conditions

Striae Distensae

Keywords

alba

Outcome Measures

Primary Outcomes (1)

• Size of SD alba scars pre and post treatment.

  Measurement of scar dimensions pre and post treatment (width x length x depth in mm) as measured by 3D photography, also 2D photography, subject satisfaction and biopsy (histology).

  3 months

Secondary Outcomes (1)

• Frequency and severity of implant site reactions post treatment.

  3 months

Study Arms (3)

ELAPR002f

EXPERIMENTAL

ELAPR002f A tropoelastin polymer cross-linked with hyaluronic acid.

Device: ELAPR002f

ELAPR002g

EXPERIMENTAL

ELAPR002g A tropoelastin polymer cross-linked with hyaluronic acid.

Device: ELAPR002g

Saline

PLACEBO COMPARATOR

Saline

Device: Saline

Interventions

ELAPR002f DEVICE

Intradermal implant

ELAPR002f

ELAPR002g DEVICE

Intradermal implant

ELAPR002g

Saline DEVICE

Intradermal implant

Saline

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female subjects with at least four abdominal, hip or thigh SD alba which are approximately bilaterally symmetrical (similar dimensions/location/colour) and are of at least 6 cm in length and no more than 5mm wide.
• SD alba within an area of skin of otherwise normal, smooth, mainly flat appearance.
• Age: 30 - 55 years.
• BMI: 18.5 to 35.0 Kg/m2.
• 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 II, III or IV.

You may not qualify if:

• SD alba within an area of otherwise abnormal skin appearance including unusual lumpiness or abnormal skin laxity.
• Current or previous medical or surgical treatment of SD.
• 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 activated partial thromboplastin time (APTT) or prothrombin time (PT).
• Chronic use of aspirin, other non-steroidal anti-inflammatory drugs or other anti-platelet agents.
• History of keloid formation.
• Systemic corticosteroids within last 12 weeks.
• Diabetes or other metabolic disorders that may interfere with the subject's response to treatment in the opinion of the investigator.
• Any serious medical condition which in the opinion of the investigator would have a strong possibility of requiring systemic corticosteroid medication.
• Females who are pregnant or lactating.
• Previous administration of tropoelastin.

Sponsors & Collaborators

• Elastagen Pty Ltd: lead

Study Sites (1)

Hammersmith Medicines Research

London, NW10 7EW, United Kingdom

Location

MeSH Terms

Conditions

Striae Distensae

Condition Hierarchy (Ancestors)

Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• 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: July 26, 2015
• First Posted: July 29, 2015
• Study Start: April 16, 2015
• Primary Completion: October 3, 2017
• Study Completion: March 6, 2018
• Last Updated: July 2, 2018

Record last verified: 2018-06

Locations

GB (1)