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 @ 9:11 PM
Ignite Modification Date:
2025-12-24 @ 9:11 PM
NCT ID:
NCT04656704
Eligibility Criteria:
Inclusion Criteria:
1. At least 18 years of age
2. Established diagnosis of a sclerosing skin disease (i.e., systemic sclerosis, CREST, scleromyxedema, morphea) by a dermatologist
3. Ability and willingness to provide informed consent, participate in study visits, and undergo visit procedures
4. Symptoms are not resolved by current treatment
Exclusion Criteria:
1. Prior treatment with hyaluronidase for oral microstomia
2. Treatment with hyaluronic acid soft tissue filler in perioral region within the last 1.5 years
3. Treatment with any semi-permanent or permanent soft tissue filler in the perioral region in the last 3 years
4. New treatment initiation (within 3 months) with immune-regulating medication, including methotrexate, azathioprine, mycophenolate mofetil, cyclosporine, intravenous immunoglobulins, systemic steroids, or rituximab
5. New initiation of physical/occupational therapy for muscles of the face within the last 3 months
6. Known hypersensitivity to hyaluronidase
7. Women of reproductive potential who are or plan to become pregnant or breastfeed during study participation or are unable or not willing to use birth control during the study. Options for birth control include abstinence, double barrier (i.e. male condom and female diaphragm), vasectomy, intrauterine device, and hormonal contraception. Females who have not had menses within 1 year of the baseline, bilateral tubal ligation, hysterectomy, and/or bilateral oophorectomy do not require additional methods of contraception during study participation
8. Unstable condition or status, as per study investigator's judgment, that may lead to more likely discontinuation from the study including, but are not limited to, major, recurrent medical illnesses that may require hospital admission, and/or inability to participate in all study visits
9. Concurrent topical steroid use during the study (Note: topical steroid use up until the start of the study enrollment is allowed and no washout period will be required)
10. Concurrent ingestion of high dose salicylates, cortisone, ACTH, estrogens, or antihistamines
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04656704
Study Brief:
Protocol Section:
NCT04656704