Keratosis Pilaris (KP)KPNCT07078461
Investigating the Safety and Efficacy of the 1927-nm Thulium Laser in Keratosis Pilaris
A study testing 1927-nm Thulium Laser therapy in people with Keratosis Pilaris (KP), run by Johns Hopkins University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Keratosis Pilaris (KP)
- What is being tested?
- 1927-nm Thulium Laser therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Oct 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins University
Baltimore, Maryland, 21287
Ruizhi Wang, 410-502-7546, rwang@jhmi.edu
Sarah Hsu, MD
About this study
Official title: Investigating the Safety and Efficacy of the 1927-nm Thulium Laser for Soft Tissue Coagulation in Keratosis Pilaris
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. While KP is benign, it can be cosmetically very bothersome. Currently, treatment options for KP are limited, and consist of topical moisturizers and keratolytic agents, but often leads to suboptimal improvements. In literature, many laser treatment modalities for KP have been studied, with varying results. The primary aim of this pilot study is to investigate how KP, a predominantly follicular disorder, responds to treatment with the 1927-nm Thulium laser.
Read the detailed description
The non-ablative fractional 1927nm Thulium laser (LaseMD ULTRA) is approved by the Food and Drug Administration (FDA) for use in dermatological procedures requiring soft-tissue coagulation, such as treatment of actinic keratosis (pre-cancerous spots), and treatment of benign pigmented lesions such as, but not limited to lentigos (age spots), solar lentigos (sunspots) and ephelides (freckles). It is not approved for use for soft-tissue coagulation in keratosis pilaris.
It has been used in previous studies to treat conditions including acne scarring, skin rejuvenation, enlarged sebaceous glands, dyschromia, rosacea, and actinic keratoses. Its role as a potential treatment option for KP, remains unexplored.
- Conditions
- Keratosis Pilaris (KP)
- Being tested
- 1927-nm Thulium Laser therapy
- Keywords
- keratosis pilaris, thulium, laser
- Medical subject headings
- Burnett Schwartz Berberian syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1927-nm Thulium Laser therapyDevice
The investigators will use the LaseMD LEO Laser System (1927-nm Thulium laser) to create controlled, localized microscopic treatment zones (MTZs) of thermal injury to treatment area (unilateral upper arm). The investigators will utilize the random mode using the C1 tip (spot size 200 micrometers), which involves irradiation of the entire upper arm until diffuse erythema and edema appear. Additionally, the investigators may use the C5 tip (350 micrometers spot size) for focused treatment, up to five passes, until coagulation becomes evident. The maximum fluence for all C1 tip is 3-60 J/cm2 and 1-20 J/cm2 for C5 tips. The maximum pulse energy is 20 J with a pulse duration of 20 ms.
| Study group | Role | What they receive |
|---|---|---|
| 1927-nm Thulium Laser therapy (right arm) | Active comparator | Participants will receive treatment for Keratosis Pilaris with the 1927-nm Thulium laser on the right arm. Receives: Device: 1927-nm Thulium Laser therapy |
| 1927-nm Thulium Laser therapy (left arm) | Active comparator | Participants will receive treatment for Keratosis Pilaris with the 1927-nm Thulium laser on the left arm. Receives: Device: 1927-nm Thulium Laser therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Severity as assessed by the Investigator's Global Assessment (IGA)
IGA score will be assessed by two blinded dermatologists for each arm based for two categories (erythema and texture/skin roughness) from standardized digital photographs. Scale ranges from 0 (clear) - 3 (severe). Lower score better.
Measured: 6 weeks, 12 weeks, 18 weeks, 24 weeks, 2 follow up visits up to 3 months
Secondary outcomes (2)
Global Improvement Scale (GIS)
Global Improvement Scale (GIS) as rated by patients at last study visit and at follow-up visit(s). Scale range 0 (no improvement) - 4 (excellent improvement). Higher score better.
Measured: 24 weeks, 2 follow up visits up to 3 months
Participant Satisfaction
Participant satisfaction rated from 0 (unsatisfied) - 3 (satisfied). Higher score more satisfaction.
Measured: 24 weeks, 2 follow up visits up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start23 Oct 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Keratosis Pilaris (KP)Studies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Prospective cohort, open-label, split-body, randomized, single-blinded study
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah Hsu, MD, Principal investigator, Johns Hopkins UniversityMyriam Gonzalez, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07078461
- Sponsor's protocol ID
- IRB00461291
- Acronym
- KP
- Status last verified
- Nov 2025
- First submitted
- 21 Jul 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Weiss ET, Brauer JA, Anolik R, Reddy KK, Karen JK, Hale EK, Brightman LA, Bernstein L, Geronemus RG. 1927-nm fractional resurfacing of facial actinic keratoses: a promising new therapeutic option. J Am Acad Dermatol. 2013 Jan;68(1):98-102. doi: 10.1016/j.jaad.2012.05.033. Epub 2012 Oct 2.
PubMed 23041112Hassan AS, Abdel Aziz M, Saadi DG. Clinical and Dermoscopic Evaluation of Trichloroacetic Acid 20% Versus Long-Pulsed 1064-nm Nd-YAG Laser in the Treatment of Keratosis Pilaris. Dermatol Surg. 2022 Aug 1;48(8):838-842. doi: 10.1097/DSS.0000000000003488. Epub 2022 Jun 15.
PubMed 35917264Wong PC, Wang MA, Ng TJ, Akbarialiabad H, Murrell DF. Keratosis pilaris treatment paradigms: assessing effectiveness across modalities. Clin Exp Dermatol. 2024 Sep 18;49(10):1105-1117. doi: 10.1093/ced/llae066.
PubMed 38447098Wang MA, Wilson A, Murrell DF. A Review of the Scoring and Assessment of Keratosis Pilaris. Skin Appendage Disord. 2023 Aug;9(4):241-251. doi: 10.1159/000529487. Epub 2023 Apr 20.
PubMed 37564689
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Safety and Efficacy of the 1927-nm Thulium Laser for Soft Tissue Coagulation in Keratosis Pilaris
- ClinicalTrials.gov ID
- NCT07078461
- Acronym / sponsor ID
- KP / IRB00461291
- Conditions
- Keratosis Pilaris (KP)
- Keywords
- keratosis pilaris, thulium, laser
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 23 Oct 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 22 Jul 2025 (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.
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. While KP is benign, it can be cosmetically very bothersome. Currently, treatment options for KP are limited, and consist of topical moisturizers and keratolytic agents, but often leads to suboptimal improvements. In literature, many laser treatment modalities for KP have been studied, with varying results. The primary aim of this pilot study is to investigate how KP, a predominantly follicular disorder, responds to treatment with the 1927-nm Thulium laser.
Detailed description
The non-ablative fractional 1927nm Thulium laser (LaseMD ULTRA) is approved by the Food and Drug Administration (FDA) for use in dermatological procedures requiring soft-tissue coagulation, such as treatment of actinic keratosis (pre-cancerous spots), and treatment of benign pigmented lesions such as, but not limited to lentigos (age spots), solar lentigos (sunspots) and ephelides (freckles). It is not approved for use for soft-tissue coagulation in keratosis pilaris.
It has been used in previous studies to treat conditions including acne scarring, skin rejuvenation, enlarged sebaceous glands, dyschromia, rosacea, and actinic keratoses. Its role as a potential treatment option for KP, remains unexplored.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective cohort, open-label, split-body, randomized, single-blinded study
| Arm | Type | Receives |
|---|---|---|
| 1927-nm Thulium Laser therapy (right arm) | Active comparator | Device: 1927-nm Thulium Laser therapyParticipants will receive treatment for Keratosis Pilaris with the 1927-nm Thulium laser on the right arm. |
| 1927-nm Thulium Laser therapy (left arm) | Active comparator | Device: 1927-nm Thulium Laser therapyParticipants will receive treatment for Keratosis Pilaris with the 1927-nm Thulium laser on the left arm. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (15 listed)
- 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
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 |
|---|---|---|
| 1927-nm Thulium Laser therapyThe investigators will use the LaseMD LEO Laser System (1927-nm Thulium laser) to create controlled, localized microscopic treatment zones (MTZs) of thermal injury to treatment area (unilateral upper arm). The investigators will utilize the random mode using the C1 tip (spot size 200 micrometers), which involves irradiation of the entire upper arm until diffuse erythema and edema appear. Additionally, the investigators may use the C5 tip (350 micrometers spot size) for focused treatment, up to five passes, until coagulation becomes evident. The maximum fluence for all C1 tip is 3-60 J/cm2 and 1-20 J/cm2 for C5 tips. The maximum pulse energy is 20 J with a pulse duration of 20 ms. | Device | 1927-nm Thulium Laser therapy (left arm), 1927-nm Thulium Laser therapy (right arm) |
Primary outcome
Disease Severity as assessed by the Investigator's Global Assessment (IGA)
Time frame: 6 weeks, 12 weeks, 18 weeks, 24 weeks, 2 follow up visits up to 3 months
IGA score will be assessed by two blinded dermatologists for each arm based for two categories (erythema and texture/skin roughness) from standardized digital photographs. Scale ranges from 0 (clear) - 3 (severe). Lower score better.
2 secondary outcomes
Global Improvement Scale (GIS)
Time frame: 24 weeks, 2 follow up visits up to 3 months
Participant Satisfaction
Time frame: 24 weeks, 2 follow up visits up to 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Background: PubMed 23041112Weiss ET, Brauer JA, Anolik R, Reddy KK, Karen JK, Hale EK, Brightman LA, Bernstein L, Geronemus RG. 1927-nm fractional resurfacing of facial actinic keratoses: a promising new therapeutic option. J Am Acad Dermatol. 2013 Jan;68(1):98-102. doi: 10.1016/j.jaad.2012.05.033. Epub 2012 Oct 2.
- Background: PubMed 35917264Hassan AS, Abdel Aziz M, Saadi DG. Clinical and Dermoscopic Evaluation of Trichloroacetic Acid 20% Versus Long-Pulsed 1064-nm Nd-YAG Laser in the Treatment of Keratosis Pilaris. Dermatol Surg. 2022 Aug 1;48(8):838-842. doi: 10.1097/DSS.0000000000003488. Epub 2022 Jun 15.
- Background: PubMed 38447098Wong PC, Wang MA, Ng TJ, Akbarialiabad H, Murrell DF. Keratosis pilaris treatment paradigms: assessing effectiveness across modalities. Clin Exp Dermatol. 2024 Sep 18;49(10):1105-1117. doi: 10.1093/ced/llae066.
- Background: PubMed 37564689Wang MA, Wilson A, Murrell DF. A Review of the Scoring and Assessment of Keratosis Pilaris. Skin Appendage Disord. 2023 Aug;9(4):241-251. doi: 10.1159/000529487. Epub 2023 Apr 20.
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.
Sarah Hsu, MD principal investigator
Johns Hopkins University
Myriam Gonzalez, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1927-nm Thulium Laser therapy in people with Keratosis Pilaris (KP), run by Johns Hopkins University at 1 site in United States.
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 6 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Youkyung S Roh, MD (410-502-7546, yroh2@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Severity as assessed by the Investigator's Global Assessment (IGA) (time frame: 6 weeks, 12 weeks, 18 weeks, 24 weeks, 2 follow up visits up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07078461, which also lists 4 linked publications.
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 26 Nov 2025.