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 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