Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-24 @ 10:22 PM
NCT ID:
NCT03056235
Eligibility Criteria:
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
* 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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT03056235
Study Brief:
Protocol Section:
NCT03056235