Nail PsoriasisNCT07919873
Efficacy of Fractional Co2 Laser With Topical Tacrolimus 0.1 in the Treatment of Nail Psoriasis
A study testing fractional C02 laser and Topical tacrolimus 0.1% ointment in people with Nail Psoriasis, run by Cairo University.
Trial summary
Nail psoriasis can change how your nails look and cause pain, making everyday activities uncomfortable and affecting your confidence. Treatments include creams or ointments, injections, medicines that work throughout the body, and laser therapy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Nail Psoriasis
- What is being tested?
- fractional C02 laser and Topical tacrolimus 0.1% ointment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Feb 2027
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients of both genders.
- 2 or more fingers affected of any grade of nail psoriasis.
- isolated nail psoriasis or nail psoriasis associated with skin lesions.
Who cannot join
- Patiens on systemic treatment for nail psoriasis in last 3 month.
- keloid or hypertrophic scarring.
- Patients with only one affected nail .
- collagen vascular disease.
About this study
Official title: Comparison Between Efficacy of Fractional CO2 Laser Combined With Topical Tacrolimus 0.1% Versus Topical Tacrolimus 0.1% Alone in the Treatment of Nail Psoriasis
Nail psoriasis can change how your nails look and cause pain, making everyday activities uncomfortable and affecting your confidence. Treatments include creams or ointments, injections, medicines that work throughout the body, and laser therapy. The choice depends on your age, symptoms, overall health, preferences, and possible side effects.
Steroid injections can help, but they may be painful and can cause bruising under the nail or thinning of the skin around the injection site. Fractional CO2 laser creates tiny channels in the nail to help medicines applied to it pass through more easily. Studies have reported improvement with laser treatment, although adding certain ointments has not always worked better than laser alone.
Tacrolimus 0.1% ointment has also shown promising results. The proposed study aims to find out whether combining this ointment with fractional CO2 laser works better than using the ointment alone.
Read the detailed description
Nail psoriasis is a common finding in psoriatic patients with a negative impact on the quality of life. The cosmetic disfigurement leads to social embarrassment and the associated pain may interfere with the daily physical activities1.2.
Therapeutic options for nail psoriasis include topical, intralesional, systemic agents, and laser treatment. The choice of treatments depends on multiple factors, including the age, the burden of the disease, accompanying diseases, individual preferences, and the risks of treatment 3.
Intramatricial corticosteroid injection has been used for many years in nail psoriasis with good results; the steroid of choice is triamcinolone acetonide despite its efficacy, the intralesional injection can be quite painful and pain management methods may be required before treatment. It can also be associated with adverse effects, such as subungual hematoma formation and injection site atrophy 4,5.
Ablative fractional CO2 laser (FCL) has been commonly used for the treatment of nail diseases owing to its ability to create microchannels to enhance drug permeation and assist the transungual delivery of topically applied drugs suggesting that it might be useful in the treatment of nail psoriasis6,7.
Fractional CO2 laser combined with topical methotrexate on one side and topical (calcipotriol/betamethasone) on the other side in nail psoriasis and showed marked clinical improvement with both regimens 8.
Another study was done to compare fractional CO2 laser versus fractional CO2 laser plus betamethasone/calcipotriol ointment in treatment of nail psoriasis.
Topical vitamin D derivatives with corticosteroids show improvement in nail psoriasis in the combined therapy group. This improvement was not superior to fractional CO2 laser monotherapy 9.
Tacrolimus 0.1% ointment has been studed in the treatment of nail psoriasis with a good clinical response 10.
To the best of our knowledge, no studies were found to compare efficacy of fractional CO2 laser combined with topical tacrolimus 0.1% in the treatment of nail psoriasis.
- Conditions
- Nail Psoriasis
- Being tested
- fractional C02 laser, Topical tacrolimus 0.1% ointment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fractional C02 laserDevice
three sessions of fractional CO2 laser with 4-week intervals in addition to topical tacrolimus 0.1% ointment, applied right after the treatment and in between sessions. The DEKA fractional CO2 laser will be used with the following parameters: 20 W, 2000-ms dwell time, 5 stacks, and 500-mm spacing.
Topical tacrolimus 0.1% ointmentDrug
topical tacrolimus oint 0.1% will be applied to the fingernail daily for 3 months
| Study group | Role | What they receive |
|---|---|---|
| fractional with tacrolimus | Active comparator | one finger nail receiving fractional carbon dioxide laser followed by topical tacrolimus Receives: Device: fractional C02 laser |
| topical tacrolimus | Active comparator | one similar fingernail on the opposite hand receiving only topical tacrolimus 0.1 Receives: Drug: Topical tacrolimus 0.1% ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
the improvement of the Target Nail Psoriasis Severity Index (tNAPSI) score before and after treatment
Comparison of the improvement in each group individually and between both groups
Measured: 3 months
Secondary outcomes (1)
patients satisfaction
Patient satisfaction at the end of the study by grading as excellent, very good, good, below average, or poor.
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 posted5 Nov 2026
- Study startNov 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nail 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona Mostafa Korany Mahmoud, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07919873
- Sponsor's protocol ID
- Dermatology 27
- Status last verified
- Nov 2026
- First submitted
- 1 Nov 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Efficacy of Fractional CO2 Laser Combined With Topical Tacrolimus 0.1% Versus Topical Tacrolimus 0.1% Alone in the Treatment of Nail Psoriasis
- ClinicalTrials.gov ID
- NCT07919873
- Acronym / sponsor ID
- Dermatology 27
- Conditions
- Nail Psoriasis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 5 Nov 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.
Nail psoriasis can change how your nails look and cause pain, making everyday activities uncomfortable and affecting your confidence. Treatments include creams or ointments, injections, medicines that work throughout the body, and laser therapy. The choice depends on your age, symptoms, overall health, preferences, and possible side effects.
Steroid injections can help, but they may be painful and can cause bruising under the nail or thinning of the skin around the injection site. Fractional CO2 laser creates tiny channels in the nail to help medicines applied to it pass through more easily. Studies have reported improvement with laser treatment, although adding certain ointments has not always worked better than laser alone.
Tacrolimus 0.1% ointment has also shown promising results. The proposed study aims to find out whether combining this ointment with fractional CO2 laser works better than using the ointment alone.
Detailed description
Nail psoriasis is a common finding in psoriatic patients with a negative impact on the quality of life. The cosmetic disfigurement leads to social embarrassment and the associated pain may interfere with the daily physical activities1.2.
Therapeutic options for nail psoriasis include topical, intralesional, systemic agents, and laser treatment. The choice of treatments depends on multiple factors, including the age, the burden of the disease, accompanying diseases, individual preferences, and the risks of treatment 3.
Intramatricial corticosteroid injection has been used for many years in nail psoriasis with good results; the steroid of choice is triamcinolone acetonide despite its efficacy, the intralesional injection can be quite painful and pain management methods may be required before treatment. It can also be associated with adverse effects, such as subungual hematoma formation and injection site atrophy 4,5.
Ablative fractional CO2 laser (FCL) has been commonly used for the treatment of nail diseases owing to its ability to create microchannels to enhance drug permeation and assist the transungual delivery of topically applied drugs suggesting that it might be useful in the treatment of nail psoriasis6,7.
Fractional CO2 laser combined with topical methotrexate on one side and topical (calcipotriol/betamethasone) on the other side in nail psoriasis and showed marked clinical improvement with both regimens 8.
Another study was done to compare fractional CO2 laser versus fractional CO2 laser plus betamethasone/calcipotriol ointment in treatment of nail psoriasis.
Topical vitamin D derivatives with corticosteroids show improvement in nail psoriasis in the combined therapy group. This improvement was not superior to fractional CO2 laser monotherapy 9.
Tacrolimus 0.1% ointment has been studed in the treatment of nail psoriasis with a good clinical response 10.
To the best of our knowledge, no studies were found to compare efficacy of fractional CO2 laser combined with topical tacrolimus 0.1% in the treatment of nail psoriasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fractional with tacrolimus | Active comparator | Device: fractional C02 laserone finger nail receiving fractional carbon dioxide laser followed by topical tacrolimus |
| topical tacrolimus | Active comparator | Drug: Topical tacrolimus 0.1% ointmentone similar fingernail on the opposite hand receiving only topical tacrolimus 0.1 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients of both genders.
- 2 or more fingers affected of any grade of nail psoriasis.
- isolated nail psoriasis or nail psoriasis associated with skin lesions.
Key exclusion criteria (4 listed)
- Patiens on systemic treatment for nail psoriasis in last 3 month.
- keloid or hypertrophic scarring.
- Patients with only one affected nail .
- collagen vascular disease.
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 C02 laserthree sessions of fractional CO2 laser with 4-week intervals in addition to topical tacrolimus 0.1% ointment, applied right after the treatment and in between sessions. The DEKA fractional CO2 laser will be used with the following parameters: 20 W, 2000-ms dwell time, 5 stacks, and 500-mm spacing. | Device | fractional with tacrolimus |
| Topical tacrolimus 0.1% ointmenttopical tacrolimus oint 0.1% will be applied to the fingernail daily for 3 months | Drug | topical tacrolimus |
Primary outcome
the improvement of the Target Nail Psoriasis Severity Index (tNAPSI) score before and after treatment
Time frame: 3 months
Comparison of the improvement in each group individually and between both groups
1 secondary outcome
patients satisfaction
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 5 Nov 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing fractional C02 laser and Topical tacrolimus 0.1% ointment in people with Nail Psoriasis, run by Cairo University.
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 4 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 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
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?
the improvement of the Target Nail Psoriasis Severity Index (tNAPSI) score before and after treatment (time frame: 3 months). 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 5 Nov 2026.