Vitiligo VulgarisPhase 4NB-UVBNCT07563049
Possible Augmentation Of NB-UVB Induced Pigmentation In NSV By Carboxy.
A Phase 4 study testing NB-UVB alone and NB-UVB combined with carboxy in people with Vitiligo Vulgaris, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
Patients with stable vitiligo with 2 or more symmetric patches, 2 on acral sites and/or 2 on non acral sites will be recruited and assessed for eligibility for inclusion to receive NB-UVB on the whole body, and carboxytherapy on one randomized side. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitiligo Vulgaris
- What is being tested?
- NB-UVB alone and NB-UVB combined with carboxy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Sep 2024to 1 Jun 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with stable non-segmental vitiligo (≥2 symmetrical patches of diameter less than 2 cm on acral or ≥ 2 symmetrical patches on non-acral sites). Subjects were stable for twelve or more months.
Who cannot join
- Subjects with unstable vitiligo.
- Subjects with segmental vitiligo.
- Pregnant females.
- Severe anemia (Hb <7 gm/dl).
- Cardiac/hepatic/renal/respiratory failure.
- Superficial thrombophlebitis.
Show all 9Show fewer
- Subjects with history of skin malignancy or precancerous conditions like Xeroderma pigmentosum.
- Subjects with other autoimmune disorders.
- Systemic drugs for vitiligo in the last 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation Of Carboxytherapy As An Adjuvant To Narrowband-Ultraviolet B Phototherapy For The Treatment Of Stable Non-Segmental Vitiligo: A Clinical And Biochemical Study .
Patients with stable vitiligo with 2 or more symmetric patches, 2 on acral sites and/or 2 on non acral sites will be recruited and assessed for eligibility for inclusion to receive NB-UVB on the whole body, and carboxytherapy on one randomized side.
- Conditions
- Vitiligo Vulgaris
- Being tested
- NB-UVB alone, NB-UVB combined with carboxy
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NB-UVB aloneDevice
Narrow-Band Ultraviolet B phototherapy full cabin
NB-UVB combined with carboxyDevice
Narrow-Band Ultraviolet B phototherapy full cabin combined with Intradermal injection of carbon dioxide gas
| Study group | Role | What they receive |
|---|---|---|
| NB-UVB | Placebo comparator | Not described Receives: Device: NB-UVB alone |
| NB-UVB combined with carboxy | Active comparator | Not described Receives: Device: NB-UVB combined with carboxy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitiligo Extent Score for a Target Area (VESTA)
Assessment of the treatment response in a target area Range 0-100%
Measured: 6 months- 1 year
Estimation of human E-Cadherin using ELISA
Measured: 6 months -1 year
Estimation of malondialdehyde by spectrophotometer
Measured: 6 months-1 year
Secondary outcomes (1)
Patients' global satisfaction
five-point grading scale
-1-3
Measured: 6 months -1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start15 Sep 2024
- Primary completion22 Dec 2025
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitiligo VulgarisStudies 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
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rana F Hilal, MD, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07563049
- Sponsor's protocol ID
- VitCarboxy
- Acronym
- NB-UVB
- Status last verified
- Apr 2026
- First submitted
- 25 Apr 2026
- Last updated
- 1 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of Carboxytherapy As An Adjuvant To Narrowband-Ultraviolet B Phototherapy For The Treatment Of Stable Non-Segmental Vitiligo: A Clinical And Biochemical Study .
- ClinicalTrials.gov ID
- NCT07563049
- Acronym / sponsor ID
- NB-UVB / VitCarboxy
- Conditions
- Vitiligo Vulgaris
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 15 Sep 2024 (actual)
- Primary completion
- 22 Dec 2025 (actual)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 1 May 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.
Patients with stable vitiligo with 2 or more symmetric patches, 2 on acral sites and/or 2 on non acral sites will be recruited and assessed for eligibility for inclusion to receive NB-UVB on the whole body, and carboxytherapy on one randomized side.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NB-UVB | Placebo comparator | Device: NB-UVB alone |
| NB-UVB combined with carboxy | Active comparator | Device: NB-UVB combined with carboxy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects with stable non-segmental vitiligo (≥2 symmetrical patches of diameter less than 2 cm on acral or ≥ 2 symmetrical patches on non-acral sites). Subjects were stable for twelve or more months.
Key exclusion criteria (9 listed)
- Subjects with unstable vitiligo.
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 |
|---|---|---|
| NB-UVB aloneNarrow-Band Ultraviolet B phototherapy full cabin | Device | NB-UVB |
| NB-UVB combined with carboxyNarrow-Band Ultraviolet B phototherapy full cabin combined with Intradermal injection of carbon dioxide gas | Device | NB-UVB combined with carboxy |
Primary outcome
Vitiligo Extent Score for a Target Area (VESTA)
Time frame: 6 months- 1 year
Assessment of the treatment response in a target area Range 0-100%
Estimation of human E-Cadherin using ELISA
Time frame: 6 months -1 year
Estimation of malondialdehyde by spectrophotometer
Time frame: 6 months-1 year
1 secondary outcome
Patients' global satisfaction
Time frame: 6 months -1 year
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 1 May 2026.
- Individual participant dataSharing planned: Yes
Related trials for Vitiligo Vulgaris
RecruitingPhase 2
A Study of EB06 Versus Placebo in Adults With Moderate to Severe Non-segmental Vitiligo
Non-Segmental Vitiligo (NSV)
RecruitingObservational study
National Ophthalmic Genotyping and Phenotyping Network (eyeGENE (Registered Trademark)), Stage 3 - Expansion of DNA and Data Repositories for Rare Inherited Ophthalmic Diseases
Inherited Ophthalmic Diseases, Hypopigmentation Disorder
Not yet recruitingPhase 2/3
Two Trials to Evaluate TEV-53408 in Participants With Non-Segmental Vitiligo
Vitiligo
RecruitingPhase 2
A Study of LY4005130 in Adult Participants With Non-Segmental Vitiligo
Vitiligo, Non-Segmental Vitiligo (NSV)
Active, not recruitingPhase 2
A Study of Zasocitinib in Adults With Nonsegmental Vitiligo
Nonsegmental Vitiligo
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 NB-UVB alone and NB-UVB combined with carboxy in people with Vitiligo Vulgaris, run by Kasr El Aini Hospital 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 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: under way, not looking for participants, as of the sponsor's last update on 1 May 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. Some participants in this study may receive a placebo. 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?
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?
Vitiligo Extent Score for a Target Area (VESTA) (time frame: 6 months- 1 year). The study lists 3 primary outcomes in all. 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 1 May 2026.