LeukodermaNCT07837908
Fractional CO2 Laser vs Dermabrasion With 5-Fluorouracil for Acquired Leukoderma
A study testing Fractional CO2 Laser, Dermabrasion and 5-Fluorouracil in people with Leukoderma and Hypopigmentation, run by Al-Azhar University at 1 site in Egypt.
Trial summary
This randomized controlled prospective single-blinded comparative clinical study aims to compare the efficacy and safety of fractional carbon dioxide (CO2) laser therapy versus mechanical dermabrasion, both combined with topical 5-fluorouracil, in the treatment of acquired non-vitiligo leukoderma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Leukoderma, Hypopigmentation
- What is being tested?
- Fractional CO2 Laser, Dermabrasion and 5-Fluorouracil
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 26 Aug 2026to 26 Aug 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients receiving topical treatment will be required to undergo a two-week washout period.
- No sex predilection.
- Cooperative patients.
- Patients with non-vitiligo leukoderma, including post-burn leukoderma, post-inflammatory hypopigmentation, and stable hypopigmented scar.
Who cannot join
- Vitiligo leukoderma.
- History of bleeding disorder or current anticoagulant therapy.
- Pregnancy or lactation.
- Keloid scarring or hypertrophic scars.
- Unrealistic expectations.
- Laser therapy within one month prior to enrollment.
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- Koebnerization.
- Photosensitivity.
- Seizure disorders.
- Active dermatosis or active bacterial, viral, or fungal cutaneous infection within the treatment area.
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
Faculty of medicine, Al-Azhar University Assuit
Asyut, Asyut Governorate, 71511
About this study
Official title: Fractional Co2 Laser vs Dermabrasion 5-Flurouracil Delivery in Acquired Leukoderma: A Comparative Study
This randomized controlled prospective single-blinded comparative clinical study aims to compare the efficacy and safety of fractional carbon dioxide (CO2) laser therapy versus mechanical dermabrasion, both combined with topical 5-fluorouracil, in the treatment of acquired non-vitiligo leukoderma. The study will evaluate repigmentation, clinical improvement, patient satisfaction, and treatment-related adverse effects.
Read the detailed description
'Non-vitiligo leukoderma represents a heterogeneous group of acquired hypopigmentary disorders that may occur following burns, inflammatory dermatoses, trauma, or other cutaneous insults. Treatment can be challenging because of altered skin architecture, scar formation, and impaired melanocyte function or availability.
This randomized controlled prospective single-blinded comparative clinical study will include 16 patients with acquired non-vitiligo leukoderma recruited from the outpatient clinic of Al-Azhar University Hospital (Assiut). Eligible lesions will be treated using either fractional carbon dioxide (CO2) laser therapy followed by topical 5-fluorouracil or mechanical dermabrasion followed by topical 5-fluorouracil. Random allocation will be performed using a computer-generated random allocation sequence.
Fractional CO2 laser sessions will be performed at 4-6-week intervals, with a total of 3-4 sessions. Mechanical dermabrasion will be performed until pinpoint bleeding appears, followed immediately by topical 5-fluorouracil application, with a total of 3-4 sessions. Similar post-procedure care will be provided.
Treatment outcomes will be assessed using objective and subjective measures, including the Vancouver Scar Scale, Vitiligo Analysis by Computer Assisted Grid (VACAG), assessment of treatment-related adverse effects, physician assessment of clinical improvement using the Mean Improvement Score by Physician (MISP), standardized clinical photography, and patient satisfaction using a 10-point visual analogue scale. Adverse effects such as infection, scarring, Koebner phenomenon, aggravation of depigmentation, pain, burning sensation, erythema, and edema will be documented.
The study will be conducted after approval by the local Ethics Committee of the Faculty of Medicine, Al-Azhar University, Assiut. Written and verbal informed consent will be obtained from participating patients, and privacy of the collected data will be maintained.'
- Conditions
- Leukoderma, Hypopigmentation
- Being tested
- Fractional CO2 Laser, Dermabrasion, 5-Fluorouracil
- Medical subject headings
- Vitiligo, Hypopigmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fractional CO2 LaserDevice
Fractional carbon dioxide (CO2) laser therapy followed by topical 5-fluorouracil application. Laser parameters will be adjusted according to lesion size and site.
DermabrasionProcedure or surgery
Mechanical dermabrasion using manual or motor-driven dermabrasion followed immediately by topical 5-fluorouracil application.
5-FluorouracilDrug
Topical 5-fluorouracil applied immediately after fractional CO2 laser or dermabrasion according to the assigned study arm.
| Study group | Role | What they receive |
|---|---|---|
| Fractional CO2 Laser + 5-Fluorouracil | Experimental | Patients will receive fractional carbon dioxide (CO2) laser therapy followed by topical 5-fluorouracil. Laser parameters will be adjusted according to the site and size of the lesions. Treatment sessions will be performed at 4-6-week intervals for a total of 3-4 sessions. Post-procedure care will include topical antibiotic ointment and emollients. Receives: Device: Fractional CO2 Laser; Drug: 5-Fluorouracil |
| Dermabrasion + 5-Fluorouracil | Active comparator | Patients will undergo mechanical dermabrasion using manual or motor-driven dermabrasion until the appearance of pinpoint bleeding, followed immediately by topical 5-fluorouracil application. A total of 3-4 sessions will be performed. Similar post-procedure care will be provided. � Receives: Procedure: Dermabrasion; Drug: 5-Fluorouracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of Repigmentation
Repigmentation will be assessed by two blinded dermatologists using the Mean Improvement Score by Physician (MISP), based on a 5-grade scale: grade 1, <25% improvement; grade 2, 25-49%; grade 3, 50-74%; grade 4, >75-99%; and grade 5, 100% complete repigmentation.
Measured: At baseline and 6 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study start26 Aug 2026 (estimated)
- Primary completion26 Jul 2027 (estimated)
- Study completion26 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukodermaStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walaa Ashraf Sayed, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07837908
- Sponsor's protocol ID
- MSC/AZ.AST./DVA021/9/245/4/26
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fractional Co2 Laser vs Dermabrasion 5-Flurouracil Delivery in Acquired Leukoderma: A Comparative Study
- ClinicalTrials.gov ID
- NCT07837908
- Acronym / sponsor ID
- MSC/AZ.AST./DVA021/9/245/4/26
- Conditions
- Leukoderma, Hypopigmentation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 26 Aug 2026 (estimated)
- Primary completion
- 26 Jul 2027 (estimated)
- Study completion
- 26 Aug 2027 (estimated)
- First posted
- 24 Sep 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.
This randomized controlled prospective single-blinded comparative clinical study aims to compare the efficacy and safety of fractional carbon dioxide (CO2) laser therapy versus mechanical dermabrasion, both combined with topical 5-fluorouracil, in the treatment of acquired non-vitiligo leukoderma. The study will evaluate repigmentation, clinical improvement, patient satisfaction, and treatment-related adverse effects.
Detailed description
'Non-vitiligo leukoderma represents a heterogeneous group of acquired hypopigmentary disorders that may occur following burns, inflammatory dermatoses, trauma, or other cutaneous insults. Treatment can be challenging because of altered skin architecture, scar formation, and impaired melanocyte function or availability.
This randomized controlled prospective single-blinded comparative clinical study will include 16 patients with acquired non-vitiligo leukoderma recruited from the outpatient clinic of Al-Azhar University Hospital (Assiut). Eligible lesions will be treated using either fractional carbon dioxide (CO2) laser therapy followed by topical 5-fluorouracil or mechanical dermabrasion followed by topical 5-fluorouracil. Random allocation will be performed using a computer-generated random allocation sequence.
Fractional CO2 laser sessions will be performed at 4-6-week intervals, with a total of 3-4 sessions. Mechanical dermabrasion will be performed until pinpoint bleeding appears, followed immediately by topical 5-fluorouracil application, with a total of 3-4 sessions. Similar post-procedure care will be provided.
Treatment outcomes will be assessed using objective and subjective measures, including the Vancouver Scar Scale, Vitiligo Analysis by Computer Assisted Grid (VACAG), assessment of treatment-related adverse effects, physician assessment of clinical improvement using the Mean Improvement Score by Physician (MISP), standardized clinical photography, and patient satisfaction using a 10-point visual analogue scale. Adverse effects such as infection, scarring, Koebner phenomenon, aggravation of depigmentation, pain, burning sensation, erythema, and edema will be documented.
The study will be conducted after approval by the local Ethics Committee of the Faculty of Medicine, Al-Azhar University, Assiut. Written and verbal informed consent will be obtained from participating patients, and privacy of the collected data will be maintained.'
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fractional CO2 Laser + 5-Fluorouracil | Experimental | Device: Fractional CO2 Laser, Drug: 5-FluorouracilPatients will receive fractional carbon dioxide (CO2) laser therapy followed by topical 5-fluorouracil. Laser parameters will be adjusted according to the site and size of the lesions. Treatment sessions will be performed at 4-6-week intervals for a total of 3-4 sessions. Post-procedure care will include topical antibiotic ointment and emollients. |
| Dermabrasion + 5-Fluorouracil | Active comparator | Procedure: Dermabrasion, Drug: 5-FluorouracilPatients will undergo mechanical dermabrasion using manual or motor-driven dermabrasion until the appearance of pinpoint bleeding, followed immediately by topical 5-fluorouracil application. A total of 3-4 sessions will be performed. Similar post-procedure care will be provided. � |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients receiving topical treatment will be required to undergo a two-week washout period.
- No sex predilection.
- Cooperative patients.
- Patients with non-vitiligo leukoderma, including post-burn leukoderma, post-inflammatory hypopigmentation, and stable hypopigmented scar.
Key exclusion criteria (10 listed)
- Vitiligo leukoderma.
- History of bleeding disorder or current anticoagulant therapy.
- Pregnancy or lactation.
- Keloid scarring or hypertrophic scars.
- Unrealistic expectations.
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 LaserFractional carbon dioxide (CO2) laser therapy followed by topical 5-fluorouracil application. Laser parameters will be adjusted according to lesion size and site. | Device | Fractional CO2 Laser + 5-Fluorouracil |
| DermabrasionMechanical dermabrasion using manual or motor-driven dermabrasion followed immediately by topical 5-fluorouracil application. | Procedure or surgery | Dermabrasion + 5-Fluorouracil |
| 5-FluorouracilTopical 5-fluorouracil applied immediately after fractional CO2 laser or dermabrasion according to the assigned study arm. | Drug | Dermabrasion + 5-Fluorouracil, Fractional CO2 Laser + 5-Fluorouracil |
Primary outcome
Degree of Repigmentation
Time frame: At baseline and 6 months after treatment
Repigmentation will be assessed by two blinded dermatologists using the Mean Improvement Score by Physician (MISP), based on a 5-grade scale: grade 1, <25% improvement; grade 2, 25-49%; grade 3, 50-74%; grade 4, >75-99%; and grade 5, 100% complete repigmentation.
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 24 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers.
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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 study testing Fractional CO2 Laser, Dermabrasion and 5-Fluorouracil in people with Leukoderma and Hypopigmentation, run by Al-Azhar 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 4 inclusion and 10 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 24 Sep 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.
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 Walaa Ashraf Sayed (MBBS, walaaashraf464@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of Repigmentation (time frame: At baseline and 6 months after treatment). 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 24 Sep 2026.