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 @ 1:40 PM
Ignite Modification Date:
2025-12-24 @ 1:40 PM
NCT ID:
NCT02320695
Eligibility Criteria:
Inclusion Criteria:
1. Males and females, 18-75 years of age, of any race or ethnicity, in generally good health as determined by a medically-qualified individual
2. Provide a signed and dated informed consent form prior to start of any study-related procedures
3. Able to comprehend and follow the requirements of the study;
4. Females of childbearing potential must have a negative urine pregnancy test at the Screening/Baseline visit;
5. Male or non-pregnant, non-lactating females agree to the contraceptive requirements (including female partner's use of a highly effective form of birth control. Females must have used the same birth control for 1 month before Screening and continue to use it through 1 month after administration of study drug)
6. Willing and able to comply with the tape stripping and all study procedures and attend the scheduled visits for the duration of the study
Exclusion Criteria:
1. Suspected alcohol or substance abuse (e.g., amphetamines, benzodiazepines, cocaine, marijuana, opiates)
2. Females who are pregnant (positive urine pregnancy test at screening/baseline) or breastfeeding
3. Males with a pregnant partner or a partner who is currently trying to become pregnant
4. Using steroidal medication (topical or systemic) currently and within 30 days before Visit 1
5. Ingestion of systemic anti-histamines or analgesics within the 3 days before Visit 1
6. Known sensitivity or allergies to the investigational products, to first aid preparations or local anesthetics (e.g. gauze products, pramoxine), or to adhesive bandages
7. Known allergies to unscented soap
8. Tendency of forming keloids after wounding
9. Tattoos located on the surface of one or both inner (volar) region of forearms
10. Heavily pigmented subjects who could heal with abnormal darkening at the test sites on the inner forearms
11. Presence of excessive hair on the inner forearms which could interfere with the test procedures
12. Presents with skin disorders on the inner arms (cuts, scratches, scars, etc), which in the opinion of the Investigator or qualified designee, will interfere with the study assessment or will create undue risk for the subject
13. Pre-existing or dormant dermatologic skin conditions (e.g., eczema, seborrheic dermatitis, atopic dermatitis, psoriasis, vitiligo, etc.) that could interfere with the outcome of the study as determined by the Investigator or qualified designee
14. Other medical condition that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02320695
Study Brief:
Protocol Section:
NCT02320695