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Not Yet Recruiting NCT05666011

Laser to Aid in Treatment of Keratosis Pilaris on Arms

Conditions: Keratosis Pilaris

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: 1
Phase: NA
Enrollment: 10
Sponsor: Goldman, Butterwick, Fitzpatrick and Groff

Summary

To assess efficacy and safety of intense pulsed light (IPL) activation of silver nanoparticles (SNA) versus IPL alone for treatment of keratosis pilaris.

Eligibility Criteria

Inclusion Criteria:Adult males and females aged 18 or older with clinical diagnosis of KP of the posterior upper arms.Subjects in good general health based on investigator's judgment and medical historyUnderstands and accepts obligation not to receive any other procedures on the treatment area through the length of the studyUnderstands and accepts the obligation and is logistically able to be present for all visitsIs willing to comply with all requirements of the study and sign the informed consent documentsMust be willing to maintain usual sun exposure for the duration of the studySubject agrees to avoid tanning or use of sunless tanner during the entire course of the studySubject agrees to avoid any changes in current skincare regimen.Negative urine pregnancy test result at the time of study entry (if applicable)For female subjects of childbearing potential, must be willing to use an acceptable form of birth control during the entire course of the study. All systemic birth control measures must be in consistent use for at least 30 days prior to study enrollment.A female is considered of childbearing potential unless she is postmenopausal, without a uterus and/or both ovaries, or has had a bilateral tubal ligation.Acceptable methods of birth control are: oral contraceptives, contraceptive patches/rings/implants, Implanon®, Depo-Provera®, double-barrier methods (e.g., condoms and spermicide), abstinence, and/or vasectomy of partner with a documented second acceptable method of birth control, should the subject become sexually active.Exclusion Criteria:Female subjects who are pregnant, planning a pregnancy, or breast feeding during the studyThe subject is hypersensitive to light in the visible and/or near infrared wavelength regionThe subject is taking medication which is known to increase sensitivity to sunlightThe subject has a seizure disorder triggered by lightThe subject has a pacemakerThe subject has a metal implant that interferes with the transmission of energy to the electrical fieldThe subject has any embedded electronic devices that give or receive a signal such as Implantable Cardiac Defibrillators (ICD) or Cardiac Resynchronization Therapy (CRT) devices: treatment may interfere with the functionality of the device and/or damage the electronic implantGold or metal allergyThe subject has nerve insensitivity to heat in the treatment area or in the neutral pad placement area or a neuropathic disorderThe subject has used topical keratolytics, retinoids, chemical or mechanical exfoliative treatments in the 30 days prior to application of study treatmentDermal fillers, biostimulators, laser treatments, or other energy-based light treatments during the 6-month period before study treatmentSubjects with tattoos in the treatment areasSubjects with a significant history or current evidence of a medical, psychological, or other disorder that, in the investigator's opinion, would preclude enrollment into the studySubjects with a history of or presence of any skin condition/disease (including but not limited to any visible rash, atopic dermatitis, psoriasis, actinic keratoses, neoplasm of uncertain behavior, or untreated keratinocyte carcinoma/melanoma, etc.) in the treatment area that might interfere with the diagnosis or evaluation of study parametersHistory of keloid or hypertrophic scarringSubjects with an active bacterial, viral, or fungal infection of the treatment areasThe subject has a significant systemic illness, such as lupus, or an illness localized in area being treatedSubjects planning any cosmetic procedure to the treatment areas during the study period, other than the treatment that will be performed by the investigatorPresence of incompletely healed wound(s) in the treatment areaCurrent participation or participation within 30 days prior to the start of this study in a drug or other investigational research study

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Source: ClinicalTrials.gov (NCT05666011). StuddyBuddy aggregates publicly available trial information.