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:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2025-12-25 @ 3:25 AM
NCT ID:
NCT04582305
Eligibility Criteria:
Inclusion Criteria:
1. Subject has provided written informed consent;
2. Subject is ≥ 18 years of age at time of screening;
3. Subject has at least one keloid scar of ≥ 4 cm in length, or two separate keloids with a length of ≥2cm, with a minimum \> 1.0 cm apart in the same anatomical region.
4. Subject is willing to fill in questionnaires and take photos using an e-diary application on their phone.
Exclusion Criteria:
1. Known hypersensitivity to any component of the test materials;
2. Pregnant or breast-feeding women (pregnancy test prior to treatment);
3. Previous bleomycin treatment of the keloid within the last 12 weeks prior to screening.
4. Non-response to previous bleomycin treatments of the keloid.
5. Any medical or psychiatric condition which, in the investigator's opinion, would preclude the participant from adhering to the protocol or completing the study per protocol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04582305
Study Brief:
Protocol Section:
NCT04582305