Striae DistensaePhase 1NCT02510768
A Study to Evaluate the Efficacy of ELAPR in Women With Striae Distensae Alba
A Phase 1 study testing ELAPR002f, ELAPR002g and Saline in people with Striae Distensae, run by Elastagen Pty Ltd at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Striae Distensae
- What is being tested?
- ELAPR002f, ELAPR002g and Saline
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Apr 2015to 6 Mar 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Striae Distensae
- Being tested
- ELAPR002f, ELAPR002g, Saline
- Keywords
- alba
- Medical subject headings
- Striae Distensae
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELAPR002fDevice
Intradermal implant
ELAPR002gDevice
Intradermal implant
SalineDevice
Intradermal implant
| Study group | Role | What they receive |
|---|---|---|
| ELAPR002f | Experimental | ELAPR002f A tropoelastin polymer cross-linked with hyaluronic acid. Receives: Device: ELAPR002f |
| ELAPR002g | Experimental | ELAPR002g A tropoelastin polymer cross-linked with hyaluronic acid. Receives: Device: ELAPR002g |
| Saline | Placebo comparator | Saline Receives: Device: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 months
Secondary outcomes (1)
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2015 (estimated)
- Study start16 Apr 2015
- Primary completion3 Oct 2017
- Study completion6 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Striae DistensaeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elastagen Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02510768
- Sponsor's protocol ID
- ELAPR-P1C
- Status last verified
- Jun 2018
- First submitted
- 26 Jul 2015
- Last updated
- 2 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02510768
- Acronym / sponsor ID
- ELAPR-P1C
- Conditions
- Striae Distensae
- Keywords
- alba
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Elastagen Pty LtdIndustry (pharma, biotech, devices)
- Study start
- 16 Apr 2015 (actual)
- Primary completion
- 3 Oct 2017 (actual)
- Study completion
- 6 Mar 2018 (actual)
- First posted
- 29 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ELAPR002f | Experimental | Device: ELAPR002fELAPR002f A tropoelastin polymer cross-linked with hyaluronic acid. |
| ELAPR002g | Experimental | Device: ELAPR002gELAPR002g A tropoelastin polymer cross-linked with hyaluronic acid. |
| Saline | Placebo comparator | Device: SalineSaline |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ELAPR002fIntradermal implant | Device | ELAPR002f |
| ELAPR002gIntradermal implant | Device | ELAPR002g |
| SalineIntradermal implant | Device | Saline |
Primary outcome
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).
1 secondary outcome
Frequency and severity of implant site reactions post treatment.
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ELAPR002f, ELAPR002g and Saline in people with Striae Distensae, run by Elastagen Pty Ltd at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Size of SD alba scars pre and post treatment. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2018.