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NCT Number: NCT07713212

Combined Fractional CO₂ Laser and Topical Corticosteroid Versus Topical Corticosteroid Only in the Treatment of Palmoplantar Psoriasis

To assess whether adding fractional laser to topical corticosteroid improves treatment outcomes in palmoplanter psoriasis compared to topical corticosteroid alone.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cairo University

Cairo, Cairo Governorate, 11562, Egypt

Location contact

Amira Elbendary, MD

CONTACT

[email protected]

About this study

· To evaluate and compare the reduction in disease severity of palmoplantar psoriasis using the Palmoplantar Psoriasis Area and Severity Index (PPPASI) in both treatment groups

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged ≥18 years
  • Stable psoriasis
  • Confirmed cases of palmoplantar psoriasis (with or without psoriasis elsewhere) dermoscopically(Hand _held dermoscopy) and histopathologically if required.
  • Willingness to comply with treatment and follow-up
  • Written informed consent obtained

Exclusion criteria

  • Other palmoplantar dermatoses (eczema, tinea, keratoderma)
  • Generlized Pustular psoriasis
  • Erythrodermic psoriasis
  • Use of:
  • Systemic antipsoriatic therapy within 3 months
  • Biologic therapy within 12 weeks
  • Topical treatment on palms/soles within 2 weeks
  • Pregnancy or lactation
  • History of photosensitivity disorders

Treatment and study plan

Fractional CO2 laser assisted drug delivery

Device

Sessions of fractional CO2 every 4 weeks with application of topical steroids

Other names: fractional CO2 laser

Topical Corticosteroid (TCS)

Drug

Daily application of topical corticosteroids on palmoplantar psoriasis

Other names: Topical steroids

Primary outcomes

  1. Improvement in Palmoplantar Psoriasis Severity Index (ppPASI) by topical corticosteroids only vs fractional CO₂ laser-assisted delivery of topical corticosteroids

    Time frame: 3 month

    The primary outcome will be the change in the Palmoplantar Psoriasis Severity Index (ppPASI) score from baseline to the end of treatment (at Week 12). The ppPASI assesses disease severity based on erythema, scaling, and induration/infiltration of the palms and soles, in addition to the affected surface area. Scores range from 0 to 72, with higher scores indicating more severe disease.

    Treatment success: Achievement of ppPASI-50, ppPASI-75, and ppPASI-90 (≥50%, ≥75%, and ≥90% reduction from baseline).

Secondary outcomes

  1. Physician Global Assessment (PGA)

    Time frame: 3 months

    Clinical improvement will be assessed using the Physician Global Assessment for palmoplantar psoriasis.

    The PGA is a 5- or 6-point scale:

    0 = Clear

    • = Almost clear
    • = Mild
    • = Moderate
    • = Severe
    • = Very severe (if using the 6-point scale)

Study contacts

Contact information is provided by the study sponsor or research team.

Amira M Elbendary, MD

CONTACT

[email protected]

+201555668584

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Comparative Study of the Efficacy and Safety of Combined Fractional CO₂ Laser and Topical Corticosteroid Versus Topical Corticosteroid Only in the Treatment of Palmoplantar Psoriasis: A Pilot Randomized Controlled Clinical Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 20, 2026
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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