Focal VitiligoEarly Phase 1NCT07742982
Efficacy of Topical Tyrosine Versus Topical 5-Fluorouracil With Fractional Erbium YAG Laser
A Early Phase 1 study testing Tyrosine in people with Focal Vitiligo, run by Aswan University at 1 site in Egypt.
Trial summary
Vitiligo is an autoimmune disorder affecting the skin, specifically targeting pigment-producing melanocytes, leading to noticeable regions of depigmentation characterized by white spots. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Focal Vitiligo
- What is being tested?
- Tyrosine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2026to 10 Jun 2027
- Phase
- Early Phase 1
- 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
- Patients with focal vitiligo
Who cannot join
- Pregnancy.
- Lactation.
- Patients with segmental vitiligo.
- Patients with autoimmune disease including thyroiditis.
- Patients with chronic systemic diseases,such as anemia ,diabetes mellitus, immunosuppression, or chronic infections.
- Patients with active skin infections.
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, 1 recruiting
- Recruiting
Aswan University Hospital
Aswān
Mahmoud Ahmed Ali, Lecturer, +201002364902, mahmoudali@aswu.edu.eg
Mohamed Amer Ahmed Abdellatif, Lecturer, +01060394083, mohammed.abdellatif@aswu.edu.eg
About this study
Official title: Efficacy of Topical Tyrosine Versus Topical 5-Fluorouracil With Fractional Erbium YAG Laser in Focal Vitiligo: A Randomised Clinical Trial
Vitiligo is an autoimmune disorder affecting the skin, specifically targeting pigment-producing melanocytes, leading to noticeable regions of depigmentation characterized by white spots.
It is a widely prevalent skin disorder globally, affecting males and females almost equally, although it is reported slightly more frequently in females. In more than 60% of patients, the disease begins before the age of 30 and It has an estimated prevalence of roughly 0.2-2% across various populations, with around 0.4% in the European-derived white (EUR) population.
Read the detailed description
Vitiligo is an autoimmune disorder affecting the skin, specifically targeting pigment-producing melanocytes, leading to noticeable regions of depigmentation characterized by white spots. Two major clinical forms of vitiligo are recognized: non-segmental vitiligo, the most common type, usually presenting with symmetrical lesions, and segmental vitiligo, which manifests as unilateral depigmentation.
The exact pathogenesis of vitiligo remains unclear. However, it is believed to be a complex process involving genetic susceptibility, metabolic disturbances related to oxidative stress, impaired melanocyte adhesion to the epidermis, and immune mechanisms including both innate and adaptive immunity, ultimately leading to selective melanocyte destruction. Nevertheless, none of these mechanisms alone can completely explain melanocyte loss, suggesting that vitiligo is a multifactorial disorder.
The management of vitiligo aims to halt disease progression, stimulate repigmentation, and prevent relapse, with repigmentation largely driven by melanocyte stem cells in hair follicles that can migrate and restore functional melanocytes to depigmented areas.
Immune modulators, such as topical steroids, topical calcineurin inhibitiors, phototherapies, and systemic therapy like oral steroids, are the mainstay of traditional treatments. However, these options are still not ideal, which prompts research into novel vitiligo treatments. There is still a need for workable and well-tolerated therapeutic choices, even if treatment must be tailored to each patient and particular lesions.
5-Fluorouracil (5-FU) is a hydrophilic pyrimidine analogue with significant anticancer activity and limited water solubility, first discovered in the 1950s by Heidelberger through the introduction of a fluorine atom at the fifth position of the uracil molecule.
Topical (5-FU) was first reported as a treatment for vitiligo where it stimulates the proliferation of melanocytes within hair follicles that subsequently migrate to the epidermis and contribute to vmelanin production.
Tyrosine is a non-essential amino acid that is primarily obtained through dietary intake. It can also be synthesized from the essential amino acid phenylalanine through a hydroxylation reaction catalyzed by the enzyme phenylalanine hydroxylase . Although this enzyme is mainly expressed in the liver, it has also been detected in melanocytes.
Melanin synthesis, including both eumelanin and pheomelanin, begins with a common biochemical pathway. In this process, the amino acid tyrosine is initially converted to L-3,4-dihydroxyphenylalanine (L-DOPA) through the action of the enzyme tyrosine hydroxylase, which utilizes tetrahydrobiopterin as a cofactor. Subsequently, tyrosinase catalyzes the oxidation of L-DOPA to dopaquinone, a crucial intermediate in melanogenesis. From this stage, the pathway diverges toward the production of either eumelanin, which appears as a brown-black pigment, or pheomelanin, characterized by red-yellow coloration, depending on the cellular conditions and the availability of substrates.
An ablative fractional laser such as the 2940-nm erbium laser produces multiple microscopic beams that create microthermal zones within the skin. These micro-injuries induce controlled thermal damage that can lead to contraction of lesional tissue and stimulate the release of cytokines and growth factors, which promote melanocyte proliferation and migration. In addition, the temporary disruption of the skin barrier enhances the penetration of topical medications and ultraviolet light, thereby improving the therapeutic response.
- Conditions
- Focal Vitiligo
- Being tested
- Tyrosine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TyrosineDrug
Also called Topical 5-Fluorouracil
to evaluate and compare the therapeutic effects of topical tyrosine and topical( 5-FU) combined with fractional erbium:YAG laser in the treatment of focal vitiligo.
| Study group | Role | What they receive |
|---|---|---|
| Topical 5-Fluorouracil Group | Active comparator | About 20 cases suffering from Focal Vitiligo will receive 6 sessions of fractional Er:YAG laser at two-week intervals. Starting [immediately ] after each laser session, patients will apply topical 5-fluorouracil (5% cream) once daily for two weeks. This 14-day topical application cycle will be repeated following each of the 6 laser sessions. Receives: Drug: Tyrosine |
| L-tyrosine Cream Group | Active comparator | About 20 cases suffering from Focal Vitiligo will receive 6 sessions of fractional Er:YAG laser at two-week intervals. Starting [immediately ] after each laser session, patients will apply topical L-tyrosine (2% cream) twice daily for two weeks. This continuous application will be maintained between laser sessions and after the final session. Receives: Drug: Tyrosine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment of Focal Vitiligo
To measure the efficacy of the treatment by Topical Tyrosine and Topical 5-Fluorouracil With Fractional Erbium YAG Laser in repigmentation, assessed by the change in the Vitiligo Area Scoring Index (VASI ) which is determined by summing the products of the number of hand units and the percentage of depigmentation for each lesion, using predefined categories of 0%, 10%, 25%, 50%, 75%, 90%, and 100%. where as 0% is the worst and 100% is the best.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start1 Jun 2026
- Primary completion1 Jun 2027 (estimated)
- Study completion10 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focal VitiligoStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aswan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasmin Mahdy Mohamed, Aswan University
- Investigators
- Moustafa Adam Ali El Taieb, Professor, Study chair, Dermatology, Venereology and Andrology, Faculty of Medicine, Aswan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07742982
- Sponsor's protocol ID
- Focal Vitiligo
- Status last verified
- Jun 2026
- First submitted
- 29 Jul 2026
- Last updated
- 11 Aug 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 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Topical Tyrosine Versus Topical 5-Fluorouracil With Fractional Erbium YAG Laser in Focal Vitiligo: A Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT07742982
- Acronym / sponsor ID
- Focal Vitiligo
- Conditions
- Focal Vitiligo
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Aswan UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 10 Jun 2027 (estimated)
- First posted
- 3 Aug 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.
Vitiligo is an autoimmune disorder affecting the skin, specifically targeting pigment-producing melanocytes, leading to noticeable regions of depigmentation characterized by white spots.
It is a widely prevalent skin disorder globally, affecting males and females almost equally, although it is reported slightly more frequently in females. In more than 60% of patients, the disease begins before the age of 30 and It has an estimated prevalence of roughly 0.2-2% across various populations, with around 0.4% in the European-derived white (EUR) population.
Detailed description
Vitiligo is an autoimmune disorder affecting the skin, specifically targeting pigment-producing melanocytes, leading to noticeable regions of depigmentation characterized by white spots. Two major clinical forms of vitiligo are recognized: non-segmental vitiligo, the most common type, usually presenting with symmetrical lesions, and segmental vitiligo, which manifests as unilateral depigmentation.
The exact pathogenesis of vitiligo remains unclear. However, it is believed to be a complex process involving genetic susceptibility, metabolic disturbances related to oxidative stress, impaired melanocyte adhesion to the epidermis, and immune mechanisms including both innate and adaptive immunity, ultimately leading to selective melanocyte destruction. Nevertheless, none of these mechanisms alone can completely explain melanocyte loss, suggesting that vitiligo is a multifactorial disorder.
The management of vitiligo aims to halt disease progression, stimulate repigmentation, and prevent relapse, with repigmentation largely driven by melanocyte stem cells in hair follicles that can migrate and restore functional melanocytes to depigmented areas.
Immune modulators, such as topical steroids, topical calcineurin inhibitiors, phototherapies, and systemic therapy like oral steroids, are the mainstay of traditional treatments. However, these options are still not ideal, which prompts research into novel vitiligo treatments. There is still a need for workable and well-tolerated therapeutic choices, even if treatment must be tailored to each patient and particular lesions.
5-Fluorouracil (5-FU) is a hydrophilic pyrimidine analogue with significant anticancer activity and limited water solubility, first discovered in the 1950s by Heidelberger through the introduction of a fluorine atom at the fifth position of the uracil molecule.
Topical (5-FU) was first reported as a treatment for vitiligo where it stimulates the proliferation of melanocytes within hair follicles that subsequently migrate to the epidermis and contribute to vmelanin production.
Tyrosine is a non-essential amino acid that is primarily obtained through dietary intake. It can also be synthesized from the essential amino acid phenylalanine through a hydroxylation reaction catalyzed by the enzyme phenylalanine hydroxylase . Although this enzyme is mainly expressed in the liver, it has also been detected in melanocytes.
Melanin synthesis, including both eumelanin and pheomelanin, begins with a common biochemical pathway. In this process, the amino acid tyrosine is initially converted to L-3,4-dihydroxyphenylalanine (L-DOPA) through the action of the enzyme tyrosine hydroxylase, which utilizes tetrahydrobiopterin as a cofactor. Subsequently, tyrosinase catalyzes the oxidation of L-DOPA to dopaquinone, a crucial intermediate in melanogenesis. From this stage, the pathway diverges toward the production of either eumelanin, which appears as a brown-black pigment, or pheomelanin, characterized by red-yellow coloration, depending on the cellular conditions and the availability of substrates.
An ablative fractional laser such as the 2940-nm erbium laser produces multiple microscopic beams that create microthermal zones within the skin. These micro-injuries induce controlled thermal damage that can lead to contraction of lesional tissue and stimulate the release of cytokines and growth factors, which promote melanocyte proliferation and migration. In addition, the temporary disruption of the skin barrier enhances the penetration of topical medications and ultraviolet light, thereby improving the therapeutic response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topical 5-Fluorouracil Group | Active comparator | Drug: TyrosineAbout 20 cases suffering from Focal Vitiligo will receive 6 sessions of fractional Er:YAG laser at two-week intervals. Starting [immediately ] after each laser session, patients will apply topical 5-fluorouracil (5% cream) once daily for two weeks. This 14-day topical application cycle will be repeated following each of the 6 laser sessions. |
| L-tyrosine Cream Group | Active comparator | Drug: TyrosineAbout 20 cases suffering from Focal Vitiligo will receive 6 sessions of fractional Er:YAG laser at two-week intervals. Starting [immediately ] after each laser session, patients will apply topical L-tyrosine (2% cream) twice daily for two weeks. This continuous application will be maintained between laser sessions and after the final session. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients with focal vitiligo
Key exclusion criteria (6 listed)
- Pregnancy.
- Lactation.
- Patients with segmental vitiligo.
- Patients with autoimmune disease including thyroiditis.
- Patients with chronic systemic diseases,such as anemia ,diabetes mellitus, immunosuppression, or chronic infections.
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 |
|---|---|---|
| TyrosineAlso: Topical 5-Fluorouracilto evaluate and compare the therapeutic effects of topical tyrosine and topical( 5-FU) combined with fractional erbium:YAG laser in the treatment of focal vitiligo. | Drug | L-tyrosine Cream Group, Topical 5-Fluorouracil Group |
Primary outcome
Treatment of Focal Vitiligo
Time frame: 1 year
To measure the efficacy of the treatment by Topical Tyrosine and Topical 5-Fluorouracil With Fractional Erbium YAG Laser in repigmentation, assessed by the change in the Vitiligo Area Scoring Index (VASI ) which is determined by summing the products of the number of hand units and the percentage of depigmentation for each lesion, using predefined categories of 0%, 10%, 25%, 50%, 75%, 90%, and 100%. where as 0% is the worst and 100% is the best.
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 11 Aug 2026.
- Individual participant dataSharing planned: Undecided
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.
Moustafa Adam Ali El Taieb, Professor study chair
Dermatology, Venereology and Andrology, Faculty of Medicine, Aswan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Tyrosine in people with Focal Vitiligo, run by Aswan 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 1 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 11 Aug 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Yasmin Mahdy Mohamed Ahmed, MSC (+201126607448, yasmin17041133@aswu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment of Focal Vitiligo (time frame: 1 year). 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 11 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.