Keratosis Pilaris (KP)KPNCT07739420
A Randomized, Assessor-Blinded, Intraindividual Study on the Efficacy of Fractional Carbon Dioxide Laser Versus Long-Pulsed 1064 nm Nd:YAG Laser in the Treatment of Keratosis Pilaris
A study testing Fractional carbon dioxide laser and Long-pulsed 1064 nm Nd:YAG laser in people with Keratosis Pilaris (KP), run by Jose R. Reyes Memorial Medical Center at 1 site in Philippines.
Trial summary
This study compares the efficacy of fractional carbon dioxide laser versus long-pulsed 1064 nm Nd:YAG laser in the treatment of keratosis pilaris. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Keratosis Pilaris (KP)
- What is being tested?
- Fractional carbon dioxide laser and Long-pulsed 1064 nm Nd:YAG laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 sitePhilippines
- Study dates
- 1 Feb 2024to 31 Dec 2024
- 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Aged 13 years old and above
- Fitzpatrick skin types III or IV
- Keratosis pilaris symmetrically affecting both upper outer arms
Who cannot join
- Other variants and subtypes of keratosis pilaris: atrophoderma vermiculatum, erythromelanosis follicularis faciei et colli, folliculitis spinulosa decalvans, keratosis follicular spinulosa decalvans, keratosis pilaris atrophicans, keratosis pilaris atrophicans faciei, and keratosis pilaris rubra
- Received any laser treatment, systemic retinoids, or dermabrasion for KP or for other indications (e.g. acne) within the past 6 months
- Received topical treatment (including emollients, keratolytic agents, retinoids, or corticosteroids) for KP within the past month
- Underwent hair removal by waxing, threading, or plucking in the areas to be treated within the past month
- History of keloids or hypertrophic scars
- Presence of other skin diseases in the area to be treated
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- History of autoimmune or photosensitive diseases
- Intake of topical or oral photosensitizing medications
- Pregnant or lactating
Trial locations and contacts
1 site in 1 country.
Philippines1 site
Department of Dermatology, Jose R. Reyes Memorial Medical Center
Manila, National Capital Region, 1003
About this study
This study compares the efficacy of fractional carbon dioxide laser versus long-pulsed 1064 nm Nd:YAG laser in the treatment of keratosis pilaris.
Read the detailed description
The main study objective is to compare the efficacy, safety, and tolerability of fractional carbon dioxide versus long-pulsed 1064 nm Nd:YAG laser in the treatment of keratosis pilaris. This is a split-body trial involving three laser sessions delivered every four weeks, followed by one follow-up visit. Improvement is measured using clinical scores based on global assessment, the number of hyperkeratotic papules, erythema, and pigmentation. Dermoscopic assessment is focused on perifollicular erythema, coiled hair, and follicular hyperkeratosis. Patient satisfaction, adverse events, and procedural pain are evaluated.
- Conditions
- Keratosis Pilaris (KP)
- Being tested
- Fractional carbon dioxide laser, Long-pulsed 1064 nm Nd:YAG 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.
Fractional carbon dioxide laserDevice
This is a fractional ablative laser.
Long-pulsed 1064 nm Nd:YAG laserDevice
This is a non-ablative laser.
| Study group | Role | What they receive |
|---|---|---|
| Fractional carbon dioxide laser | Active comparator | This group will receive treatment with fractional carbon dioxide laser. Receives: Device: Fractional carbon dioxide laser |
| Long-pulsed 1064 nm Nd:YAG laser | Active comparator | This group will receive long-pulsed 1064 nm Nd:YAG laser treatment. Receives: Device: Long-pulsed 1064 nm Nd:YAG laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Clinical Improvement or Worsening
Clinical photos were taken at baseline and 4 weeks after the last laser session using a 48-megapixel camera (iPhone 15 Pro Max, Apple). Initial assessment of the photographs was performed by the primary investigator and reviewed and verified by a blinded-board certified dermatologist. The scoring system was adapted from the Physician's Global Assessment (PGA) scoring. Baseline clinical scores for follicular keratotic papules were graded as follows: grade 1, mild = 0-25%; grade 2, moderate = 26-50%; grade 3, severe = 51-75%; grade 4, very severe = 76-100%. Erythema and pigmentation were graded as none, faint, moderate, and intense (1 to 4). Clinical improvement or worsening was rated as follows: grade -4, severe worsening >75%; grade -3, marked worsening 51-75%; grade -2, moderate worsening 26-50%; grade -1, slight worsening 0-25%; grade 0, no improvement; grade 1 mild improvement 0%-25%; grade 2, moderate improvement 26%-50%; grade 3, marked improvement 51-75%; grade 4, excellent impr
Measured: 4 months
Dermoscopic Findings Improvement or Worsening
A dermoscope (Illuco IDS-1100) with polarized and non-polarized modes was used to assess the dermoscopic findings. Dermoscopic photographs were initially assessed by the primary investigator and reviewed and verified by a blinded board-certified dermatologist with a certification in dermoscopy. Dermoscopic scores (0 to 5) for a fixed area on each treatment area were calculated at baseline and at follow-up, with perifollicular erythema graded as none, faint, moderate, and brownish (0 to 3). Coiled hair and hyperkeratosis were marked as present (1) or absent (0). These numbers were totaled per treatment area and were expressed as mean scores.
Measured: 4 months
Secondary outcomes (2)
Pain Score
Pain scores were evaluated after each laser treatment using a 10-point visual analogue scale (VAS), where 0 indicated no pain and 10 indicated extreme pain. At the end of the study, participants rated their overall satisfaction with treatment on a 5-point scale, with 0 indicating no improvement and 4 indicating excellent improvement.
Measured: 4 months
Patient Satisfaction
Patient satisfaction was graded at the end of the study based on their overall satisfaction with the laser treatment, as follows: 0 (unsatisfied), 1 (poor), 2 (fair), 3 (satisfied), 4 (extremely satisfied). This was adapted from the Client Satisfaction Questionnaire-4 (CSQ-4).
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start1 Feb 2024
- Primary completion30 Sep 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Keratosis Pilaris (KP)Studies 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
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jose R. Reyes Memorial Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Maria Korina Abao Dakis, Jose R. Reyes Memorial Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07739420
- Sponsor's protocol ID
- 2023139
- Other IDs
- 2023139
- Acronym
- KP
- Status last verified
- Jul 2026
- First submitted
- 13 Jul 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data will include age, sex, Fitzpatrick skin type, medical and family history, previous treatments for keratosis pilaris, and body weight index.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Assessor-Blinded, Intraindividual Study on the Efficacy of Fractional Carbon Dioxide Laser Versus Long-Pulsed 1064 nm Nd:YAG Laser in the Treatment of Keratosis Pilaris
- ClinicalTrials.gov ID
- NCT07739420
- Acronym / sponsor ID
- KP / 2023139
- Conditions
- Keratosis Pilaris (KP)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Jose R. Reyes Memorial Medical CenterOther government
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 31 Jul 2026 (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.
This study compares the efficacy of fractional carbon dioxide laser versus long-pulsed 1064 nm Nd:YAG laser in the treatment of keratosis pilaris.
Detailed description
The main study objective is to compare the efficacy, safety, and tolerability of fractional carbon dioxide versus long-pulsed 1064 nm Nd:YAG laser in the treatment of keratosis pilaris. This is a split-body trial involving three laser sessions delivered every four weeks, followed by one follow-up visit. Improvement is measured using clinical scores based on global assessment, the number of hyperkeratotic papules, erythema, and pigmentation. Dermoscopic assessment is focused on perifollicular erythema, coiled hair, and follicular hyperkeratosis. Patient satisfaction, adverse events, and procedural pain are evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fractional carbon dioxide laser | Active comparator | Device: Fractional carbon dioxide laserThis group will receive treatment with fractional carbon dioxide laser. |
| Long-pulsed 1064 nm Nd:YAG laser | Active comparator | Device: Long-pulsed 1064 nm Nd:YAG laserThis group will receive long-pulsed 1064 nm Nd:YAG laser treatment. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 13 years old and above
- Fitzpatrick skin types III or IV
- Keratosis pilaris symmetrically affecting both upper outer arms
Key exclusion criteria (9 listed)
- Other variants and subtypes of keratosis pilaris: atrophoderma vermiculatum, erythromelanosis follicularis faciei et colli, folliculitis spinulosa decalvans, keratosis follicular spinulosa decalvans, keratosis pilaris atrophicans, keratosis pilaris atrophicans faciei, and keratosis pilaris rubra
- Received any laser treatment, systemic retinoids, or dermabrasion for KP or for other indications (e.g. acne) within the past 6 months
- Received topical treatment (including emollients, keratolytic agents, retinoids, or corticosteroids) for KP within the past month
- Underwent hair removal by waxing, threading, or plucking in the areas to be treated within the past month
- History of keloids or hypertrophic scars
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 |
|---|---|---|
| Fractional carbon dioxide laserThis is a fractional ablative laser. | Device | Fractional carbon dioxide laser |
| Long-pulsed 1064 nm Nd:YAG laserThis is a non-ablative laser. | Device | Long-pulsed 1064 nm Nd:YAG laser |
Primary outcome
Assessment of Clinical Improvement or Worsening
Time frame: 4 months
Clinical photos were taken at baseline and 4 weeks after the last laser session using a 48-megapixel camera (iPhone 15 Pro Max, Apple). Initial assessment of the photographs was performed by the primary investigator and reviewed and verified by a blinded-board certified dermatologist. The scoring system was adapted from the Physician's Global Assessment (PGA) scoring. Baseline clinical scores for follicular keratotic papules were graded as follows: grade 1, mild = 0-25%; grade 2, moderate = 26-50%; grade 3, severe = 51-75%; grade 4, very severe = 76-100%. Erythema and pigmentation were graded as none, faint, moderate, and intense (1 to 4). Clinical improvement or worsening was rated as follows: grade -4, severe worsening >75%; grade -3, marked worsening 51-75%; grade -2, moderate worsening 26-50%; grade -1, slight worsening 0-25%; grade 0, no improvement; grade 1 mild improvement 0%-25%; grade 2, moderate improvement 26%-50%; grade 3, marked improvement 51-75%; grade 4, excellent impr
Dermoscopic Findings Improvement or Worsening
Time frame: 4 months
A dermoscope (Illuco IDS-1100) with polarized and non-polarized modes was used to assess the dermoscopic findings. Dermoscopic photographs were initially assessed by the primary investigator and reviewed and verified by a blinded board-certified dermatologist with a certification in dermoscopy. Dermoscopic scores (0 to 5) for a fixed area on each treatment area were calculated at baseline and at follow-up, with perifollicular erythema graded as none, faint, moderate, and brownish (0 to 3). Coiled hair and hyperkeratosis were marked as present (1) or absent (0). These numbers were totaled per treatment area and were expressed as mean scores.
2 secondary outcomes
Pain Score
Time frame: 4 months
Patient Satisfaction
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Individual participant dataSharing planned: Yes. Individual participant data will include age, sex, Fitzpatrick skin type, medical and family history, previous treatments for keratosis pilaris, and body weight index.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fractional carbon dioxide laser and Long-pulsed 1064 nm Nd:YAG laser in people with Keratosis Pilaris (KP), run by Jose R. Reyes Memorial Medical Center at 1 site in Philippines.
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 3 inclusion and 9 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: finished, as of the sponsor's last update on 31 Jul 2026. 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 Philippines. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Clinical Improvement or Worsening (time frame: 4 months). The study lists 2 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 31 Jul 2026.