Non-segmental VitiligoPhase 4NCT04811326
Latanoprost Plus NB-UVB Versus Each Alone in Non-segmental Vitiligo: Clinical and Laboratory Evaluation
A Phase 4 study testing NB-UVB and Latanoprost in people with Non-segmental Vitiligo, run by Shaimaa Fawzy Abdel-rady Abdel-latif at 1 site in Egypt.
Trial summary
The aim of the study is to evaluate the efficacy of different lines of therapies on the TWEAK serum level in patients with non-segmental vitiligo. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Non-segmental Vitiligo
- What is being tested?
- NB-UVB and Latanoprost
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 13 Jan 2021to 13 Mar 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients with non-segmental vitiligo of any age and gender.
Who cannot join
- History of vitiligo treatment with topical, systemic or biological agents prior to the study for at least 3 weeks.
- Pregnancy and lactation.
- Infections
- Patients with other autoimmune diseases.
- Patients with chronic diseases: cardiac diseases, hepatic disorders, hematologic disease, chronic renal failure or malignancies.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
faculty of medicine, Aswan University
Aswān, Aswan Governorate, 81528
About this study
The aim of the study is to evaluate the efficacy of different lines of therapies on the TWEAK serum level in patients with non-segmental vitiligo.
Read the detailed description
the study is to evaluate the efficacy of NB-UVB, latanoprost, and combination of them on the TWEAK serum level in patients with non-segmental vitiligo.
- Conditions
- Non-segmental Vitiligo
- Being tested
- NB-UVB, Latanoprost
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NB-UVBRadiation
Also called narrow band ultraviolet B
radiation
LatanoprostDrug
Also called latanoprost eye drops
eye drops
| Study group | Role | What they receive |
|---|---|---|
| NB-UVB radiation | Active comparator | will expose to 2 sessions/week of NB-UVB radiation, for 3 months. Receives: Radiation: NB-UVB |
| Latanoprost | Active comparator | latanoprost 0.005%, will be applied after microneedling, by using 1.5-2 mm needle length dermapen, of vitiligenous patches. The procedure will be repeated once weekly for 3 months (12 sessions). Receives: Drug: Latanoprost |
| latanoprost + NB-UVB | Active comparator | (latanoprost + NB-UVB group): latanoprost 0.005%, will be applied after microneedling of vitiligenous patches in the same day of NB-UVB sessions in the same manner of group 2. Receives: Radiation: NB-UVB; Drug: Latanoprost |
| healthy individuals | No intervention | healthy individuals as control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum TWEAK in vitiligo
measurement of serum Tumor necrosis factor weak inducer of apoptosis (TWEAK)"pg/ml"; in vitiligo patients before and after treatment with NB-UVB, Latanoprost and their combination, all in comparison with healthy individuals, using ELISA (enzyme-linked immunosorbent assay)
Measured: 3months
Secondary outcomes (1)
treatment of vitiligo
clinical evaluation: Assessment of the disease severity in non-segmental vitiligo will be performed by using vitiligo area severity index (VASI score) before and after treatment with NB-UVB, latanoprost application applied after microneedling, by using 1.5-2 mm needle length dermapen, of vitiligenous patches, or combination of both of them. Patients will be photographed at baseline and after 3 months of regular treatment by using high resolution digital camera conon EOS 1300D 18 megapixels (made in Taiwan), photography will be done in standard light and distance.
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 posted23 Mar 2021
- Study start13 Jan 2021
- Primary completion13 Feb 2024 (estimated)
- Study completion13 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-segmental 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
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaimaa Fawzy Abdel-rady Abdel-latif
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shaimaa Fawzy Abdel-rady Abdel-latif, Aswan University Hospital
- Investigators
- Moustafa A El Taieb, prof., Study chair, Prof. and Head of Dermatology, Venereology and Andrology department, Aswan University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04811326
- Sponsor's protocol ID
- 504/1/21
- Status last verified
- Aug 2023
- First submitted
- 7 Mar 2021
- Last updated
- 9 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Latanoprost Plus NB-UVB Versus Each Alone in Non-segmental Vitiligo: Clinical and Laboratory Evaluation
- ClinicalTrials.gov ID
- NCT04811326
- Acronym / sponsor ID
- 504/1/21
- Conditions
- Non-segmental Vitiligo
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Shaimaa Fawzy Abdel-rady Abdel-latifUniversity, hospital or other
- Study start
- 13 Jan 2021 (actual)
- Primary completion
- 13 Feb 2024 (estimated)
- Study completion
- 13 Mar 2024 (estimated)
- First posted
- 23 Mar 2021 (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.
The aim of the study is to evaluate the efficacy of different lines of therapies on the TWEAK serum level in patients with non-segmental vitiligo.
Detailed description
the study is to evaluate the efficacy of NB-UVB, latanoprost, and combination of them on the TWEAK serum level in patients with non-segmental vitiligo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| NB-UVB radiation | Active comparator | Radiation: NB-UVBwill expose to 2 sessions/week of NB-UVB radiation, for 3 months. |
| Latanoprost | Active comparator | Drug: Latanoprostlatanoprost 0.005%, will be applied after microneedling, by using 1.5-2 mm needle length dermapen, of vitiligenous patches. The procedure will be repeated once weekly for 3 months (12 sessions). |
| latanoprost + NB-UVB | Active comparator | Radiation: NB-UVB, Drug: Latanoprost(latanoprost + NB-UVB group): latanoprost 0.005%, will be applied after microneedling of vitiligenous patches in the same day of NB-UVB sessions in the same manner of group 2. |
| healthy individuals | No intervention | –healthy individuals as control group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with non-segmental vitiligo of any age and gender.
Key exclusion criteria (5 listed)
- History of vitiligo treatment with topical, systemic or biological agents prior to the study for at least 3 weeks.
- Pregnancy and lactation.
- Infections
- Patients with other autoimmune diseases.
- Patients with chronic diseases: cardiac diseases, hepatic disorders, hematologic disease, chronic renal failure or malignancies.
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-UVBAlso: narrow band ultraviolet Bradiation | Radiation | NB-UVB radiation, latanoprost + NB-UVB |
| LatanoprostAlso: latanoprost eye dropseye drops | Drug | Latanoprost, latanoprost + NB-UVB |
Primary outcome
serum TWEAK in vitiligo
Time frame: 3months
measurement of serum Tumor necrosis factor weak inducer of apoptosis (TWEAK)"pg/ml"; in vitiligo patients before and after treatment with NB-UVB, Latanoprost and their combination, all in comparison with healthy individuals, using ELISA (enzyme-linked immunosorbent assay)
1 secondary outcome
treatment of vitiligo
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2023.
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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. This study is not recruiting at the moment.
Moustafa A El Taieb, prof. study chair
Prof. and Head of Dermatology, Venereology and Andrology department, Aswan University, Egypt
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 and Latanoprost in people with Non-segmental Vitiligo, run by Shaimaa Fawzy Abdel-rady Abdel-latif 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 5 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: status not confirmed, as of the sponsor's last update on 9 Aug 2023. 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?
Results are not available in the source record.
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?
serum TWEAK in vitiligo (time frame: 3months). 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 9 Aug 2023.