Back to resultsA Study to Evaluate the Efficacy of ELAPR in Women With Striae Distensae Alba
Primary Purpose
Striae Distensae
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
ELAPR002f
ELAPR002g
Saline
Sponsored by
About this trial
This is an interventional treatment trial for Striae Distensae focused on measuring alba
Eligibility Criteria
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.
Sites / Locations
- Hammersmith Medicines Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
ELAPR002f
ELAPR002g
Saline
Arm Description
ELAPR002f A tropoelastin polymer cross-linked with hyaluronic acid.
ELAPR002g A tropoelastin polymer cross-linked with hyaluronic acid.
Saline
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Frequency and severity of implant site reactions post treatment.
Measure incidence and severity of implant site reactions as assessed by clinical observation and subject diary card records.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02510768
Brief Title
A Study to Evaluate the Efficacy of ELAPR in Women With Striae Distensae Alba
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 Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
April 16, 2015 (Actual)
Primary Completion Date
October 3, 2017 (Actual)
Study Completion Date
March 6, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Elastagen Pty Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
The study will consist of six study visits. There will be a screening visit to confirm eligibility and to assess baseline parameters (Day -28 to Day -1). For enrolled subjects there will be three intradermal (i.d.) treatment sessions of ELAPR002f or ELAPR002g and placebo, given at one-monthly intervals (approximately Day 0, Day 28 and Day 56). There will be a safety assessment visit 7 days after the first treatment session (Day 7) to review any adverse events and assess the implant sites. ELAPR002f or ELAPR002g will be administered alone vs. placebo. Subjects will be followed for a total of 12 weeks (to Day 84) following the first treatment, with efficacy and safety assessments undertaken at each study visit. At the final follow-up visit (Day 84) a biopsy sample will be taken from each of the treated SDs (active and placebo treated), together with a control biopsy of normal skin collected from an area of the lateral aspect of the abdomen, hip or thigh without an SD alba. Each study subject will act as their own control with active and placebo treatments given single-blind to contralateral sides of the abdomen, hip or thigh, into matched and paired SD. Prior to administration the selected injection sites along the length of SD alba to be treated will be identified and marked with a semi-permanent mark to ensure consistency of anatomic sites for treatment and biopsy. Follow-up period extended to D168, D336 and D504.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Striae Distensae
Keywords
alba
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ELAPR002f
Arm Type
Experimental
Arm Description
ELAPR002f A tropoelastin polymer cross-linked with hyaluronic acid.
Arm Title
ELAPR002g
Arm Type
Experimental
Arm Description
ELAPR002g A tropoelastin polymer cross-linked with hyaluronic acid.
Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
Saline
Intervention Type
Device
Intervention Name(s)
ELAPR002f
Intervention Description
Intradermal implant
Intervention Type
Device
Intervention Name(s)
ELAPR002g
Intervention Description
Intradermal implant
Intervention Type
Device
Intervention Name(s)
Saline
Intervention Description
Intradermal implant
Primary Outcome Measure Information:
Title
Size of SD alba scars pre and post treatment.
Description
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).
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Frequency and severity of implant site reactions post treatment.
Description
Measure incidence and severity of implant site reactions as assessed by clinical observation and subject diary card records.
Time Frame
3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Hammersmith Medicines Research
City
London
ZIP/Postal Code
NW10 7EW
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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A Study to Evaluate the Efficacy of ELAPR in Women With Striae Distensae Alba
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