Investigating the Safety and Efficacy of the 1927-nm Thulium Laser in Keratosis Pilaris

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 forregulatory, 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 beforerecruitment

• History of or concurrent use of radiation to the bilateral arms in the 12 monthsbefore recruitment

• Participation of other device or drug clinical trials within 1 month beforerecruitment

• 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