PsoriasisPhase 4NCT07713212
Combined Fractional CO₂ Laser and Topical Corticosteroid Versus Topical Corticosteroid Only in the Treatment of Palmoplantar Psoriasis
A Phase 4 study testing Fractional CO2 laser assisted drug delivery and Topical Corticosteroid (TCS) in people with Psoriasis, run by Cairo University at 1 site in Egypt.
Trial summary
To assess whether adding fractional laser to topical corticosteroid improves treatment outcomes in palmoplanter psoriasis compared to topical corticosteroid alone. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- Fractional CO2 laser assisted drug delivery and Topical Corticosteroid (TCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Aug 2026to 15 Feb 2027
- Phase
- Phase 4
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Other palmoplantar dermatoses (eczema, tinea, keratoderma)
- Generlized Pustular psoriasis
- Erythrodermic psoriasis
- Use of:
- Systemic antipsoriatic therapy within 3 months
- Biologic therapy within 12 weeks
Show all 9Show fewer
- Topical treatment on palms/soles within 2 weeks
- Pregnancy or lactation
- History of photosensitivity disorders
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Cairo University
Cairo, Cairo Governorate, 11562
Amira Elbendary, MD, aelbendary@kasralainy.edu.eg
About this study
Official 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
To assess whether adding fractional laser to topical corticosteroid improves treatment outcomes in palmoplanter psoriasis compared to topical corticosteroid alone.
Read the detailed description
- 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
- Conditions
- Psoriasis
- Being tested
- Fractional CO2 laser assisted drug delivery, Topical Corticosteroid (TCS)
- Keywords
- psoriasis, fractional CO2 laser, topical treatment
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fractional CO2 laser assisted drug deliveryDevice
Also called fractional CO2 laser
Sessions of fractional CO2 every 4 weeks with application of topical steroids
Topical Corticosteroid (TCS)Drug
Also called Topical steroids
Daily application of topical corticosteroids on palmoplantar psoriasis
| Study group | Role | What they receive |
|---|---|---|
| fractional carbon dioxide (CO₂) laser-assisted delivery of topical corticosteroids | Experimental | fractional carbon dioxide (CO₂) laser-assisted delivery of topical corticosteroids will be done on palmoplantar psoriasis every 4 weeks Receives: Device: Fractional CO2 laser assisted drug delivery |
| Topical corticosteroids alone | Active comparator | Application of topical corticosteroid alone in patients with palmoplantar psoriasis daily. Receives: Drug: Topical Corticosteroid (TCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Palmoplantar Psoriasis Severity Index (ppPASI) by topical corticosteroids only vs fractional CO₂ laser-assisted delivery of topical corticosteroids
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).
Measured: 3 month
Secondary outcomes (1)
Physician Global Assessment (PGA)
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)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start15 Aug 2026 (estimated)
- Primary completion15 Feb 2027 (estimated)
- Study completion15 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by Cairo 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Elbendary, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07713212
- Sponsor's protocol ID
- MS-124-2026
- Status last verified
- Jul 2026
- First submitted
- 7 Jul 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07713212
- Acronym / sponsor ID
- MS-124-2026
- Conditions
- Psoriasis
- Keywords
- psoriasis, fractional CO2 laser, topical treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Aug 2026 (estimated)
- Primary completion
- 15 Feb 2027 (estimated)
- Study completion
- 15 Feb 2027 (estimated)
- First posted
- 20 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.
To assess whether adding fractional laser to topical corticosteroid improves treatment outcomes in palmoplanter psoriasis compared to topical corticosteroid alone.
Detailed description
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fractional carbon dioxide (CO₂) laser-assisted delivery of topical corticosteroids | Experimental | Device: Fractional CO2 laser assisted drug deliveryfractional carbon dioxide (CO₂) laser-assisted delivery of topical corticosteroids will be done on palmoplantar psoriasis every 4 weeks |
| Topical corticosteroids alone | Active comparator | Drug: Topical Corticosteroid (TCS)Application of topical corticosteroid alone in patients with palmoplantar psoriasis daily. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- Other palmoplantar dermatoses (eczema, tinea, keratoderma)
- Generlized Pustular psoriasis
- Erythrodermic psoriasis
- Use of:
- Pregnancy or lactation
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 CO2 laser assisted drug deliveryAlso: fractional CO2 laserSessions of fractional CO2 every 4 weeks with application of topical steroids | Device | fractional carbon dioxide (CO₂) laser-assisted delivery of topical corticosteroids |
| Topical Corticosteroid (TCS)Also: Topical steroidsDaily application of topical corticosteroids on palmoplantar psoriasis | Drug | Topical corticosteroids alone |
Primary outcome
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).
1 secondary outcome
Physician Global Assessment (PGA)
Time frame: 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 20 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fractional CO2 laser assisted drug delivery and Topical Corticosteroid (TCS) in people with Psoriasis, run by Cairo University at 1 site in Egypt.
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 5 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: opening soon, as of the sponsor's last update on 20 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 Egypt. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Amira M Elbendary, MD (+201555668584, aelbendary@kasralainy.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in Palmoplantar Psoriasis Severity Index (ppPASI) by topical corticosteroids only vs fractional CO₂ laser-assisted delivery of topical corticosteroids (time frame: 3 month). 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 20 Jul 2026.