Laser to Aid in Treatment of Keratosis Pilaris on Arms

NCT05666011 | Unknown FDA Device

• 1 other identifier: KP-IPL
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Keratosis Pilaris

Keywords

keratosis pilaris; arms

Outcome Measures

Primary Outcomes (3)

• Erythema Grading Scale by a blinded investigator to assess change (one for each arm)

  Erythema grading scale (Right Arm) 0 No erythema 1. Mild erythema 2. Moderate erythema 3. Severe erythema 4. Very severe erythema Erythema grading scale (Left Arm) 0 No erythema 1. Mild erythema 2. Moderate erythema 3. Severe erythema 4. Very severe erythema

  Baseline, Day 30, Day 60, Day 90, Day 110

• Textural Change Grading Scale by a blinded investigator (one for each arm)

  Textural change grading scale ( Right Arm) 0 No textural change 1. Mild textural change 2. Moderate textural change 3. Severe textural change 4. Very severe textural change Textural change grading scale (Left Arm) 0 No textural change 1. Mild textural change 2. Moderate textural change 3. Severe textural change 4. Very severe textural change

  Baseline, Day 30, Day 60, Day 90, Day 110

• Investigator Global Aesthetic Improvement Scale (IGAIS) by a blinded investigator

  Blinded Physician Global Aesthetic Improvement Scale Rating Description 1. Very Much Improved- Optimal cosmetic result in this subject 2. Much Improved- Marked improvement in appearance form the initial condition, but not completely optimal for this subject. 3. Improved- Obvious improvement in appearance from initial condition, but a re- treatment is indicated. 4. No Change- The appearance is essentially the same as the original condition. 5. Worse- The appearance is worse than the original condition. Scores (write a number under each treated area or check "Not Treated") Right Arm Left Arm Not Treated Not Treated

  Day 30, Day 60, Day 90, Day 110

Secondary Outcomes (1)

• Subject Global Aesthetic Improvement Scale (SGAIS)

  Day 30, Day 60, Day 90, Day 110

Study Arms (2)

Group A -- Right side is Intervention Arm, Left side is Control Arm

EXPERIMENTAL

Right Arm will be treated with IPL activation of SNA (Silver Nanoparticles ) and left arm with IPL alone.

Device: M22 IPL

Group B -- Left side is Intervention Arm, Right side is Control Arm

EXPERIMENTAL

Left Arm will be treated with IPL activation of SNA (Silver Nanoparticles ) and right arm with IPL alone.

Device: M22 IPL

Interventions

M22 IPL DEVICE

IPL is an attractive option in the treatment of KP as the provider can utilize cut-off filters to target both melanin for hair removal and erythema with a single device. An added benefit of IPL is the larger crystal size, allowing for efficient coverage of a larger body surface area. IPL has been utilized in the treatment of KP and KP variants, with outcomes showing reductions in both erythema and texture.

Also known as: StellarM22 Intense Pulsed Light Laser

Group A -- Right side is Intervention Arm, Left side is Control Arm; Group B -- Left side is Intervention Arm, Right side is Control Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 history
• Understands and accepts obligation not to receive any other procedures on the treatment area through the length of the study
• Understands and accepts the obligation and is logistically able to be present for all visits
• Is willing to comply with all requirements of the study and sign the informed consent documents
• Must be willing to maintain usual sun exposure for the duration of the study
• Subject agrees to avoid tanning or use of sunless tanner during the entire course of the study
• Subject 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.

You may not qualify if:

• Female subjects who are pregnant, planning a pregnancy, or breast feeding during the study
• The subject is hypersensitive to light in the visible and/or near infrared wavelength region
• The subject is taking medication which is known to increase sensitivity to sunlight
• The subject has a seizure disorder triggered by light
• The subject has a pacemaker
• The subject has a metal implant that interferes with the transmission of energy to the electrical field
• The 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 implant
• Gold or metal allergy
• The subject has nerve insensitivity to heat in the treatment area or in the neutral pad placement area or a neuropathic disorder
• The subject has used topical keratolytics, retinoids, chemical or mechanical exfoliative treatments in the 30 days prior to application of study treatment
• Dermal fillers, biostimulators, laser treatments, or other energy-based light treatments during the 6-month period before study treatment
• Subjects with tattoos in the treatment areas
• Subjects 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 study
• Subjects 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 parameters
• History of keloid or hypertrophic scarring

Sponsors & Collaborators

• Goldman, Butterwick, Fitzpatrick and Groff: lead

MeSH Terms

Conditions

Burnett Schwartz Berberian syndrome; Rhabdomyosarcoma, Alveolar

Condition Hierarchy (Ancestors)

Rhabdomyosarcoma; Myosarcoma; Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Central Study Contacts

Andrea Pacheco

CONTACT

8586571004; apacheco@clderm.com

Sherif Mikhail, MD

CONTACT

8586571004; smikhail@westderm.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Blinded Investigator will be unaware of which arm received which treatment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Enrolled subjects will be randomized to combination treatment with IPL activation of SNA (i.e. intervention arm) versus IPL alone (i.e. control arm).

Study Record Dates

• First Submitted: October 21, 2022
• First Posted: December 27, 2022
• Study Start: March 20, 2023
• Primary Completion: May 30, 2023
• Study Completion: May 30, 2023
• Last Updated: March 20, 2023

Record last verified: 2022-10