A Study to Evaluate the Efficacy of ELAPR in Women With Striae Distensae Alba
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|ClinicalTrials.gov Identifier: NCT02510768|
Recruitment Status : Active, not recruiting
First Posted : July 29, 2015
Last Update Posted : February 1, 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|
|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|
|Study Start Date :||August 2015|
|Estimated Primary Completion Date :||March 2018|
|Estimated Study Completion Date :||April 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)
- 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|