Keratosis PilarisNCT05666011
Laser to Aid in Treatment of Keratosis Pilaris on Arms
A study testing M22 IPL in people with Keratosis Pilaris, run by Goldman, Butterwick, Fitzpatrick and Groff.
Trial summary
To assess efficacy and safety of intense pulsed light (IPL) activation of silver nanoparticles (SNA) versus IPL alone for treatment of keratosis pilaris. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Keratosis Pilaris
- What is being tested?
- M22 IPL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 20 Mar 2023to 30 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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.
Who cannot join
- 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
Show all 20Show fewer
- 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
- Subjects with an active bacterial, viral, or fungal infection of the treatment areas
- The subject has a significant systemic illness, such as lupus, or an illness localized in area being treated
- Subjects planning any cosmetic procedure to the treatment areas during the study period, other than the treatment that will be performed by the investigator
- Presence of incompletely healed wound(s) in the treatment area
- Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Single Center, Evaluator-Blinded, Split-Body, Randomized Pilot Study of Intense Pulsed Light Activation of Silver Nanoparticles vs. Intense Pulsed Light Alone in the Treatment of Keratosis Pilaris
To assess efficacy and safety of intense pulsed light (IPL) activation of silver nanoparticles (SNA) versus IPL alone for treatment of keratosis pilaris.
Read the detailed description
The primary objective of this pilot study is to assess efficacy and safety of intense pulsed light (IPL; StellarM22™ Universal IPL, Lumenis Ltd., Yokneam, Israel) alone versus combination of IPL activation of silver nanoparticles (SNA) for treatment of keratosis pilaris.
Prior to first treatment, right and left arms of 10 enrolled subjects will be randomized to combination treatment with IPL activation of SNA (i.e. intervention arm) versus IPL alone (i.e. control arm). The intervention arm will be pre-treated with sugaring to epilate existing hair. This arm will then be treated with 0.5mL of nanoparticle suspension administered with a standard infusion paddle for 5 minutes prior to IPL treatment.
Following nanoparticle infusion, excess suspension will be removed from the surface of the skin with a pre-moistened wipe. Once all visible suspension is removed from the skin, the area will be cleansed with an alcohol wipe. If the alcohol wipe shows that the suspension is still present on the surface of the skin, additional pre-moistened wipes will be used to cleanse the skin until the alcohol wipe comes away without visible suspension. IPL will then be applied to the intervention arm.
Treatments will be repeated three times, spaced four- to six-weeks apart. After completing all three treatments, patients will return for macroscopic and dermoscopic photography at 1 month and 3 months.
- Conditions
- Keratosis Pilaris
- Being tested
- M22 IPL
- Keywords
- keratosis pilaris, arms
- Medical subject headings
- Burnett Schwartz Berberian syndrome, Rhabdomyosarcoma, Alveolar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
M22 IPLDevice
Also called StellarM22 Intense Pulsed Light Laser
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: M22 IPL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Erythema Grading Scale by a blinded investigator to assess change (one for each arm)
Erythema grading scale (Right Arm) 0 No erythema
- Mild erythema
- Moderate erythema
- Severe erythema
- Very severe erythema
Erythema grading scale (Left Arm) 0 No erythema
- Mild erythema
- Moderate erythema
- Severe erythema
- Very severe erythema
Measured: 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
- Mild textural change
- Moderate textural change
- Severe textural change
- Very severe textural change
Textural change grading scale (Left Arm) 0 No textural change
- Mild textural change
- Moderate textural change
- Severe textural change
- Very severe textural change
Measured: 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
- Very Much Improved- Optimal cosmetic result in this subject
- Much Improved- Marked improvement in appearance form the initial condition, but not completely optimal for this subject.
- Improved- Obvious improvement in appearance from initial condition, but a re- treatment is indicated.
- No Change- The appearance is essentially the same as the original condition.
- 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
Measured: Day 30, Day 60, Day 90, Day 110
Secondary outcomes (1)
Subject Global Aesthetic Improvement Scale (SGAIS)
Subject Global Aesthetic Improvement Scale Assessment How would you rate the overall change in appearance of your treated areas? Non-treated areas will be checked as "Not Treated" for you.
Rating Description
- Very Much Improved- Optimal cosmetic result in this subject
- Much Improved- Marked improvement in appearance form the initial condition, but not completely optimal for this subject.
- Improved- Obvious improvement in appearance from initial condition, but a re-treatment is indicated.
- No Change- The appearance is essentially the same as the original condition.
- 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
Measured: Day 30, Day 60, Day 90, Day 110
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2022
- Study start20 Mar 2023 (estimated)
- Primary completion30 May 2023 (estimated)
- Study completion30 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Keratosis PilarisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Enrolled subjects will be randomized to combination treatment with IPL activation of SNA (i.e. intervention arm) versus IPL alone (i.e. control arm).
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Goldman, Butterwick, Fitzpatrick and Groff
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05666011
- Sponsor's protocol ID
- KP-IPL
- Status last verified
- Oct 2022
- First submitted
- 21 Oct 2022
- Last updated
- 20 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Evaluator-Blinded, Split-Body, Randomized Pilot Study of Intense Pulsed Light Activation of Silver Nanoparticles vs. Intense Pulsed Light Alone in the Treatment of Keratosis Pilaris
- ClinicalTrials.gov ID
- NCT05666011
- Acronym / sponsor ID
- KP-IPL
- Conditions
- Keratosis Pilaris
- Keywords
- keratosis pilaris, arms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Goldman, Butterwick, Fitzpatrick and GroffUniversity, hospital or other
- Study start
- 20 Mar 2023 (estimated)
- Primary completion
- 30 May 2023 (estimated)
- Study completion
- 30 May 2023 (estimated)
- First posted
- 27 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess efficacy and safety of intense pulsed light (IPL) activation of silver nanoparticles (SNA) versus IPL alone for treatment of keratosis pilaris.
Detailed description
The primary objective of this pilot study is to assess efficacy and safety of intense pulsed light (IPL; StellarM22™ Universal IPL, Lumenis Ltd., Yokneam, Israel) alone versus combination of IPL activation of silver nanoparticles (SNA) for treatment of keratosis pilaris.
Prior to first treatment, right and left arms of 10 enrolled subjects will be randomized to combination treatment with IPL activation of SNA (i.e. intervention arm) versus IPL alone (i.e. control arm). The intervention arm will be pre-treated with sugaring to epilate existing hair. This arm will then be treated with 0.5mL of nanoparticle suspension administered with a standard infusion paddle for 5 minutes prior to IPL treatment.
Following nanoparticle infusion, excess suspension will be removed from the surface of the skin with a pre-moistened wipe. Once all visible suspension is removed from the skin, the area will be cleansed with an alcohol wipe. If the alcohol wipe shows that the suspension is still present on the surface of the skin, additional pre-moistened wipes will be used to cleanse the skin until the alcohol wipe comes away without visible suspension. IPL will then be applied to the intervention arm.
Treatments will be repeated three times, spaced four- to six-weeks apart. After completing all three treatments, patients will return for macroscopic and dermoscopic photography at 1 month and 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Enrolled subjects will be randomized to combination treatment with IPL activation of SNA (i.e. intervention arm) versus IPL alone (i.e. control arm).
| Arm | Type | Receives |
|---|---|---|
| Group A -- Right side is Intervention Arm, Left side is Control Arm | Experimental | Device: M22 IPLRight Arm will be treated with IPL activation of SNA (Silver Nanoparticles ) and left arm with IPL alone. |
| Group B -- Left side is Intervention Arm, Right side is Control Arm | Experimental | Device: M22 IPLLeft Arm will be treated with IPL activation of SNA (Silver Nanoparticles ) and right arm with IPL alone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| M22 IPLAlso: StellarM22 Intense Pulsed Light LaserIPL 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. | Device | Group A -- Right side is Intervention Arm, Left side is Control Arm, Group B -- Left side is Intervention Arm, Right side is Control Arm |
Primary outcome
Erythema Grading Scale by a blinded investigator to assess change (one for each arm)
Time frame: Baseline, Day 30, Day 60, Day 90, Day 110
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
Textural Change Grading Scale by a blinded investigator (one for each arm)
Time frame: Baseline, Day 30, Day 60, Day 90, Day 110
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
Investigator Global Aesthetic Improvement Scale (IGAIS) by a blinded investigator
Time frame: Day 30, Day 60, Day 90, Day 110
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
1 secondary outcome
Subject Global Aesthetic Improvement Scale (SGAIS)
Time frame: Day 30, Day 60, Day 90, Day 110
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Keratosis Pilaris
Recruiting
Investigating the Safety and Efficacy of the 1927-nm Thulium Laser in Keratosis Pilaris
Keratosis Pilaris (KP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing M22 IPL in people with Keratosis Pilaris, run by Goldman, Butterwick, Fitzpatrick and Groff.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrea Pacheco (8586571004, apacheco@clderm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Erythema Grading Scale by a blinded investigator to assess change (one for each arm) (time frame: Baseline, Day 30, Day 60, Day 90, Day 110). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2023.