A Study to Evaluate the Efficacy of ELAPR in Women With Striae Distensae Alba
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|ClinicalTrials.gov Identifier: NCT02510768|
Recruitment Status : Completed
First Posted : July 29, 2015
Last Update Posted : July 2, 2018
|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|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
ELAPR002f A tropoelastin polymer cross-linked with hyaluronic acid.
ELAPR002g A tropoelastin polymer cross-linked with hyaluronic acid.
Placebo Comparator: Saline
- 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.
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
|Hammersmith Medicines Research|
|London, United Kingdom, NW10 7EW|