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

NCT07739420 | Completed

• 1 other identifier: 2023139
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Keratosis Pilaris (KP)

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  4 months

Secondary Outcomes (2)

• Pain Score

  4 months

• Patient Satisfaction

  4 months

Study Arms (2)

Fractional carbon dioxide laser

ACTIVE COMPARATOR

This group will receive treatment with fractional carbon dioxide laser.

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.

Device: Long-pulsed 1064 nm Nd:YAG laser

Interventions

Fractional carbon dioxide laser DEVICE

This is a fractional ablative laser.

Fractional carbon dioxide laser

Long-pulsed 1064 nm Nd:YAG laser DEVICE

This is a non-ablative laser.

Long-pulsed 1064 nm Nd:YAG laser

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 13 years old and above
• Fitzpatrick skin types III or IV
• Keratosis pilaris symmetrically affecting both upper outer arms

You may not qualify if:

• 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
• History of autoimmune or photosensitive diseases
• Intake of topical or oral photosensitizing medications
• Pregnant or lactating

Sponsors & Collaborators

• Jose R. Reyes Memorial Medical Center: lead

Study Sites (1)

Department of Dermatology, Jose R. Reyes Memorial Medical Center

Manila, National Capital Region, 1003, Philippines

Location

MeSH Terms

Conditions

Burnett Schwartz Berberian syndrome

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dermatology Resident/Principal Investigator

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 31, 2026
• Study Start: February 1, 2024
• Primary Completion: September 30, 2024
• Study Completion: December 31, 2024
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF

Locations

PH (1)