Keratosis Pilaris (KP)
Conditions
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.
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.
Interventions
This is a fractional ablative laser.
DEVICELong-pulsed 1064 nm Nd:YAG laser
This is a non-ablative laser.
Sponsors
Jose R. Reyes Memorial Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged 13 years old and above * Fitzpatrick skin types III or IV * Keratosis pilaris symmetrically affecting both upper outer arms
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Clinical Improvement or Worsening | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score | 4 months | 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. |
| Patient Satisfaction | 4 months | 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). |
Countries
Philippines
Outcome results
None listed