Atrophic Acne ScarNCT03056235
A Study to Evaluate the Efficacy of ELAPR002f in Females and Males With Atrophic Acne Scars
A study testing ELAPR002f and Saline in people with Atrophic Acne Scar, 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 (collectively referred to as ELAPR or ELAPR002) for the treatment of rolling atrophic acne scars when administered as intradermal implants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Atrophic Acne Scar
- What is being tested?
- ELAPR002f and Saline
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 Mar 2017to 11 Sep 2018
- Phase
- Interventional
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female/male subjects with matched treatment fields of approximately 2cm x 2cm on each side of the face on the temples or cheek bones that each contain a minimum of two rolling atrophic acne scars that are distensible when stretched between one's fingers and that are classified as moderate to severe on the scales detailed at Appendix 2.
- Acne scars in areas of otherwise normal healthy skin.
- Age: 18 - 55 years.
- 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 I, II, III, IV or V.
Who cannot join
- No active ongoing acne lesions on the face (or back and torso for the subjects who will also receive treatment in these areas).
- Subjects who present with predominantly ice pick or box scars.
- Current or previous treatment of atrophic acne scars with fillers, lasers, or deep chemical peels which reach the dermis, or any other medical or surgical treatment which in the investigators opinion could reasonably be deemed to impact on the results of the current clinical study.
- 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.
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- 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 APTT or PT.
- Chronic use of aspirin, other non-steroidal anti-inflammatory drugs or other anti-platelet agents.
- History of keloid formation.
- History of granulomatous or connective tissue disease.
- Systemic corticosteroids within last 12 weeks.
- Currently using topical retinoids, or have used topical retinoids in the past 8 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 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.
United Kingdom1 site
Hammersmith Medicines Research
London, Greater London, NW10 7EW
About this study
Official title: A Randomized, Within-subject, Placebo-controlled, Single-blind Study to Evaluate the Efficacy of ELAPR002f in Females and Males With Atrophic Acne Scars
The study is designed to evaluate the efficacy of two formulations of a cross-linked tropoelastin matrix given the product codes ELAPR002f (collectively referred to as ELAPR or ELAPR002) for the treatment of rolling atrophic acne scars when administered as intradermal implants.
Read the detailed description
The study consists of a pre-screen visit followed by seven study visits. There will be a pre-screen visit where up to 30 potential study subjects will have 2D and 3D photographs taken of the candidate treatment fields to enable the Sponsor and Trial Centre staff to set practical guidelines for subject recruitment based on example atrophic acne scar images and published acne scar assessment scales. Subjects participating in the pre-screen period may be invited to participate in the full study if they are considered to be able to meet the eligibility criteria.
There will be a screening visit to confirm eligibility and to assess baseline parameters (D-28 to D-1). In addition, the proposed treatment fields on each side of the face will be selected at screening and recorded with 2D \& 3D photographs and their location marked in detail on acetate sheets.
For enrolled subjects there will be three intradermal (i.d.) treatment sessions of ELAPR002f and placebo, given at one-monthly intervals (approximately D0, D28 and D56). The treatment at D0 will be administered so as to reduce the appearance of the atrophic rolling acne scars in the treatment field relative to the surrounding skin. The treatments at D28 and D56 will be given to optimise the treatment outcome and to minimise the appearance of the atrophic rolling acne scars in the treatment field.
In addition to the facial acne scars, a minimum of 5 subjects in each treatment group will also receive treatment on two moderate to severe, distensible, rolling acne scars present approximately 5-10cm apart on the back or torso.
There will be an assessment visit 14 and 84 days after the first treatment session (D14 and D84) to review any adverse events and assess the implant sites.
ELAPR002f will be administered alone vs. placebo. Subjects will be followed for a total of 24 weeks (to D168) following the first treatment, with efficacy and safety assessments undertaken at each study visit. At the final follow-up visit (D168) a biopsy sample will be taken from of each of the treated atrophic acne scars on the back or torso (active and placebo treated) from those subjects who received treatment to scars on the back or torso.
Each study subject will act as their own control with active and placebo treatments given single-blind to treatment fields on contralateral sides of the face. Prior to administration the selected treatment fields will be identified and marked with a washable marker using the 2D and 3D images and acetate sheets created at the screening visit to ensure consistency of anatomic sites for treatment (and biopsy for those subjects receiving treatment to the back or torso). Follow-up period extended to D336.
- Conditions
- Atrophic Acne Scar
- Being tested
- ELAPR002f, Saline
- Keywords
- Atrophic acne scar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELAPR002fDevice
30mg/ml Tropoelastin cross-linked with derivatised hyaluronic acid
SalineDevice
Saline control
| Study group | Role | What they receive |
|---|---|---|
| ELAPR002f | Experimental | ELAPR002f is a tropoelastin gel cross-linked with derivatised hyaluronic acid Receives: Device: ELAPR002f |
| Saline control | Placebo comparator | Saline Receives: Device: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of the dimensions of acne scars pre and post treatment
The volume of acne scar depressions within the treatment field will be measured using 2D and 3D camera analysis
Measured: 6 months
Secondary outcomes (1)
Assessment of product integration into dermal tissue using histological analysis
Subjects who receive treatments to acne scars on the torso will undergo biopsy and the tissue analysed using histology techniques. Measure incidence and severity of implant site reactions as assessed by clinical observation and subject diary card records.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2017
- Study start27 Mar 2017
- Primary completion23 Mar 2018
- Study completion11 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrophic Acne ScarStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elastagen Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frans Van den Berg, Doctor, Principal investigator, Hammersmith Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03056235
- Sponsor's protocol ID
- ELAPR-P1D
- Status last verified
- Sep 2018
- First submitted
- 9 Feb 2017
- Last updated
- 28 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 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 in Females and Males With Atrophic Acne Scars
- ClinicalTrials.gov ID
- NCT03056235
- Acronym / sponsor ID
- ELAPR-P1D
- Conditions
- Atrophic Acne Scar
- Keywords
- Atrophic acne scar
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Elastagen Pty LtdIndustry (pharma, biotech, devices)
- Study start
- 27 Mar 2017 (actual)
- Primary completion
- 23 Mar 2018 (actual)
- Study completion
- 11 Sep 2018 (actual)
- First posted
- 17 Feb 2017 (actual)
- 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 (collectively referred to as ELAPR or ELAPR002) for the treatment of rolling atrophic acne scars when administered as intradermal implants.
Detailed description
The study consists of a pre-screen visit followed by seven study visits. There will be a pre-screen visit where up to 30 potential study subjects will have 2D and 3D photographs taken of the candidate treatment fields to enable the Sponsor and Trial Centre staff to set practical guidelines for subject recruitment based on example atrophic acne scar images and published acne scar assessment scales. Subjects participating in the pre-screen period may be invited to participate in the full study if they are considered to be able to meet the eligibility criteria.
There will be a screening visit to confirm eligibility and to assess baseline parameters (D-28 to D-1). In addition, the proposed treatment fields on each side of the face will be selected at screening and recorded with 2D \& 3D photographs and their location marked in detail on acetate sheets.
For enrolled subjects there will be three intradermal (i.d.) treatment sessions of ELAPR002f and placebo, given at one-monthly intervals (approximately D0, D28 and D56). The treatment at D0 will be administered so as to reduce the appearance of the atrophic rolling acne scars in the treatment field relative to the surrounding skin. The treatments at D28 and D56 will be given to optimise the treatment outcome and to minimise the appearance of the atrophic rolling acne scars in the treatment field.
In addition to the facial acne scars, a minimum of 5 subjects in each treatment group will also receive treatment on two moderate to severe, distensible, rolling acne scars present approximately 5-10cm apart on the back or torso.
There will be an assessment visit 14 and 84 days after the first treatment session (D14 and D84) to review any adverse events and assess the implant sites.
ELAPR002f will be administered alone vs. placebo. Subjects will be followed for a total of 24 weeks (to D168) following the first treatment, with efficacy and safety assessments undertaken at each study visit. At the final follow-up visit (D168) a biopsy sample will be taken from of each of the treated atrophic acne scars on the back or torso (active and placebo treated) from those subjects who received treatment to scars on the back or torso.
Each study subject will act as their own control with active and placebo treatments given single-blind to treatment fields on contralateral sides of the face. Prior to administration the selected treatment fields will be identified and marked with a washable marker using the 2D and 3D images and acetate sheets created at the screening visit to ensure consistency of anatomic sites for treatment (and biopsy for those subjects receiving treatment to the back or torso). Follow-up period extended to D336.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ELAPR002f | Experimental | Device: ELAPR002fELAPR002f is a tropoelastin gel cross-linked with derivatised hyaluronic acid |
| Saline control | Placebo comparator | Device: SalineSaline |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Female/male subjects with matched treatment fields of approximately 2cm x 2cm on each side of the face on the temples or cheek bones that each contain a minimum of two rolling atrophic acne scars that are distensible when stretched between one's fingers and that are classified as moderate to severe on the scales detailed at Appendix 2.
- Acne scars in areas of otherwise normal healthy skin.
- Age: 18 - 55 years.
- Capable of providing voluntary informed consent.
- Good general health.
Key exclusion criteria (22 listed)
- No active ongoing acne lesions on the face (or back and torso for the subjects who will also receive treatment in these areas).
- Subjects who present with predominantly ice pick or box scars.
- Current or previous treatment of atrophic acne scars with fillers, lasers, or deep chemical peels which reach the dermis, or any other medical or surgical treatment which in the investigators opinion could reasonably be deemed to impact on the results of the current clinical study.
- 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.
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 |
|---|---|---|
| ELAPR002f30mg/ml Tropoelastin cross-linked with derivatised hyaluronic acid | Device | ELAPR002f |
| SalineSaline control | Device | Saline control |
Primary outcome
Measurement of the dimensions of acne scars pre and post treatment
Time frame: 6 months
The volume of acne scar depressions within the treatment field will be measured using 2D and 3D camera analysis
1 secondary outcome
Assessment of product integration into dermal tissue using histological analysis
Time frame: 6 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 28 Sep 2018.
- Individual participant dataSharing planned: No
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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.
Frans Van den Berg, Doctor principal investigator
Hammersmith Medical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ELAPR002f and Saline in people with Atrophic Acne Scar, 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 7 inclusion and 22 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 28 Sep 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.
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?
Measurement of the dimensions of acne scars pre and post treatment (time frame: 6 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 28 Sep 2018.