A Study to Evaluate the Efficacy of ELAPR in Women With Striae Distensae Alba
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02510768 |
Recruitment Status :
Completed
First Posted : July 29, 2015
Last Update Posted : July 2, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Striae Distensae | Device: ELAPR002f Device: ELAPR002g Device: Saline | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 26 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (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 Women With Striae Distensae (SD) Alba |
Actual Study Start Date : | April 16, 2015 |
Actual Primary Completion Date : | October 3, 2017 |
Actual Study Completion Date : | March 6, 2018 |
Arm | Intervention/treatment |
---|---|
Experimental: ELAPR002f
ELAPR002f A tropoelastin polymer cross-linked with hyaluronic acid.
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Device: ELAPR002f
Intradermal implant |
Experimental: ELAPR002g
ELAPR002g A tropoelastin polymer cross-linked with hyaluronic acid.
|
Device: ELAPR002g
Intradermal implant |
Placebo Comparator: Saline
Saline
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Device: Saline
Intradermal implant |
- Size of SD alba scars pre and post treatment. [ Time Frame: 3 months ]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).
- Frequency and severity of implant site reactions post treatment. [ Time Frame: 3 months ]Measure incidence and severity of implant site reactions as assessed by clinical observation and subject diary card records.

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Ages Eligible for Study: | 30 Years to 55 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- A history of anaphylaxis or allergic reactions including any known hypersensitivity to lidocaine.
- Use of any investigational product on the intended implant site in the previous 12 months.
- Fitzpatrick skin types I, V or VI.
- Any other factor that in the opinion of the Investigator would make the subject unsafe or unsuitable for the study.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02510768
United Kingdom | |
Hammersmith Medicines Research | |
London, United Kingdom, NW10 7EW |
Responsible Party: | Elastagen Pty Ltd |
ClinicalTrials.gov Identifier: | NCT02510768 |
Other Study ID Numbers: |
ELAPR-P1C |
First Posted: | July 29, 2015 Key Record Dates |
Last Update Posted: | July 2, 2018 |
Last Verified: | June 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
alba |
Striae Distensae Skin Manifestations |