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 @ 12:21 PM
Ignite Modification Date:
2025-12-24 @ 12:21 PM
NCT ID:
NCT07078461
Eligibility Criteria:
Inclusion Criteria:
* Female or male, in good health, ages 18-65
* Voluntarily signed informed consent form
* Any Fitzpatrick skin type (I-VI)
* Clinically diagnosed keratosis pilaris of bilateral upper arms
* Willing to have photographs taken and agree to the use of photographs for regulatory, presentation, or marketing purposes
* Willing and able to follow protocol procedures and requirements
Exclusion Criteria:
* History of receiving any laser therapy to the bilateral arms in the 12 months before recruitment
* History of or concurrent use of radiation to the bilateral arms in the 12 months before recruitment
* Participation of other device or drug clinical trials within 1 month before recruitment
* Concurrent diagnosis of active skin condition in the arms
* Presence of an active systemic or local skin disease that may affect wound healing
* History of forming keloids, collagen vascular disease, chronic drug or alcohol use
* History of malignant tumors in the upper arms
* Presence of open ulcers or infections any skin site
* Presence of a tan or sunburn over the upper arms in the month before recruitment
* Use of topical or oral photosensitizing medications
* Excessive body hair or tattoo in target area
* Pregnant and/or breastfeeding
* Presence of any medical conditions that interfere with subject's participation
* History of diagnosed pigmentary disorders in the target area
* Current smoker or history of smoking within 5 years
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07078461
Study Brief:
Protocol Section:
NCT07078461