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Tests treatment safety and results for Keratosis Pilaris (KP)
Official title Investigating the Safety and Efficacy of the 1927-nm Thulium Laser in Keratosis Pilaris
ClinicalTrials.gov ID: NCT07078461
What this study is testing
- What it's testing
- Keratosis pilaris (KP) is a very common skin condition that affects up to 80% of adolescents and 40% of adults. Clinically, KP causes rough dry patches and tiny spiny bumps around the hair follicles, as well as redness and pigmentation changes, most often on the upper arms, thighs, cheeks, or buttocks.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.