HyperlipidemiasNCT04245319
Combined Effect of Acitretin and Narrow Band Ultraviolet B on Vitiligo Repigmentation
A study testing Acitretin and Narrow band ultraviolet B in people with Hyperlipidemias and Xerosis, run by Cairo University at 1 site in Egypt.
Trial summary
Since abnormal keratinocyte (KC) proliferation and differentiation as well as defective E cadherin expression were reported in vitiligo lesions, the investigators set to study the potential efficacy of combining Retinoids, which are known to improve KC proliferation and differentiation and increase the expression of… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperlipidemias, Xerosis, Depression
- What is being tested?
- Acitretin and Narrow band ultraviolet B
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2020to 1 Dec 2021
- Phase
- Interventional
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with generalized non-segmental vitiligo (25%-75%)
- Males, postmenopausal females and premenopausal females not planning to get pregnant during the period of treatment and after 2 years from the end of treatment.
- Age more than 18 years.
Who cannot join
- Children ˂ 18 years old
- Pregnant females
- Premenopausal females planning to get pregnant within the period of treatment or within 2 years after.
- Patients receiving treatment for vitiligo within the past 2 months.
- Patients with abnormal liver profile
- Patients with abnormal lipid profile
Show all 10Show fewer
- Patients with associated photosensitive disorders
- Patients having associated skin diseases other than vitiligo
- Cataract and aphakia
- High cumulative dose from previous sessions of narrowband ˃ 200-300 session
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Combined Effect of Acitretin and Narrow Band Ultraviolet B (Nb-UVB) on the Clinical Repigmentation and on the Expression of E-cadherins in Vitiligo Lesions in Comparison to Narrow Band UVB Alone. A Pilot Study
Since abnormal keratinocyte (KC) proliferation and differentiation as well as defective E cadherin expression were reported in vitiligo lesions, the investigators set to study the potential efficacy of combining Retinoids, which are known to improve KC proliferation and differentiation and increase the expression of adhesion molecules, with narrowband UVB in the treatment of vitiligo.
Read the detailed description
- Twenty patients with generalized vitiligo will be included in this study.
All patients will be subjected to:
- Clinical evaluation:
- An informed written consent.
- History taking include age, previous treatment, disease activity
- Clinical examination including Vitiligo Area Scoring Index (VASI) and Vitiligo Disease Activity Score (VIDA)
- Photography (before starting the treatment and every 2 weeks till the end of the study)
Laboratory evaluation:
- 2 mm punch skin biopsies will be taken from vitiligo patients, 1 from lesional and the other from perilesional skin before treatment.
- The patients will be randomly assigned to two groups:
Group A: patients will receive three NB-UVB sessions per week for 48 sessions. Group B: patients will receive three NB-UVB sessions per week for 48 sessions combined with acitretin in a dose of 0.3mg/kg/day daily.
- Controls: 20 individuals age and sex matched will be biopsied from the skin of their abdominoplasty surgery.
- Another two 2 mm punch skin biopsies will be taken from lesional and perilesional skin at the onset of repigmentation if repigmentation starts before completion of the 48 treatment session or after completion of the treatment period if repigmentation does not occur.
- .All biopsies from patients and controls will be stained Immunohistochemically by anti-E cadherin antibody.
- Conditions
- Hyperlipidemias, Xerosis, Depression, Liver Diseases
- Being tested
- Acitretin, Narrow band ultraviolet B
- Medical subject headings
- Hyperlipidemias, Depression, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcitretinDrug
Also called Acitretin 25Mg Cap, Acitretin 10Mg Cap
The patients will receive the drug and the effect on repigmentation on vitiligo lesions will be observed
Narrow band ultraviolet BOther
Patients receive nbUVB session 3 times per week
| Study group | Role | What they receive |
|---|---|---|
| NbUVB | Other | Group A: patients will receive three NB-UVB sessions per week for 48 sessions. Receives: Other: Narrow band ultraviolet B |
| Combined nbUVB and Acitretin | Experimental | Group B: patients will receive three NB-UVB sessions per week for 48 sessions combined with acitretin in a dose of 0.3mg/kg/day daily. Receives: Drug: Acitretin; Other: Narrow band ultraviolet B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determining whether addition of acitretin is beneficial for vitiligo patients or not using Vitiligo Area Scoring Index
The number of patients who will achieve 100%, 75% and 50% repigmentation of vitiligo lesions will be compared between group A (nbUVB) and group B (nbUVB+ acitretin) after 48 nbUVB sessions. The comparison of the 2 groups will be assessed using Vitiligo Area Scoring Index (VASI)
Measured: 4-5 months
Determining whether addition of acitretin is beneficial for vitiligo patients or not using Vitiligo Disease Activity Score.
The number of patients who will achieve 100%, 75% and 50% repigmentation of vitiligo lesions will be compared between group A (nbUVB) and group B (nbUVB+ acitretin) after 48 nbUVB sessions. The comparison of the 2 groups will be assessed using Vitiligo Disease Activity Score (VIDA).
Measured: 4-5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start1 Jan 2020
- Primary completion30 Nov 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiasStudies 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
- Model description
- Two groups Group A: patients will receive three NB-UVB sessions per week for 48 sessions. Group B: patients will receive three NB-UVB sessions per week for 48 sessions combined with acitretin in a dose of 0.3 mg/kg/day daily.
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shahira Ramadan, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04245319
- Sponsor's protocol ID
- Acitretin in vitiligo
- Status last verified
- Jul 2021
- First submitted
- 21 Jan 2020
- Last updated
- 22 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Combined Effect of Acitretin and Narrow Band Ultraviolet B (Nb-UVB) on the Clinical Repigmentation and on the Expression of E-cadherins in Vitiligo Lesions in Comparison to Narrow Band UVB Alone. A Pilot Study
- ClinicalTrials.gov ID
- NCT04245319
- Acronym / sponsor ID
- Acitretin in vitiligo
- Conditions
- Hyperlipidemias, Xerosis, Depression, Liver Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Nov 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 28 Jan 2020 (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.
Since abnormal keratinocyte (KC) proliferation and differentiation as well as defective E cadherin expression were reported in vitiligo lesions, the investigators set to study the potential efficacy of combining Retinoids, which are known to improve KC proliferation and differentiation and increase the expression of adhesion molecules, with narrowband UVB in the treatment of vitiligo.
Detailed description
- Twenty patients with generalized vitiligo will be included in this study.
All patients will be subjected to:
- Clinical evaluation:
- An informed written consent.
- History taking include age, previous treatment, disease activity
- Clinical examination including Vitiligo Area Scoring Index (VASI) and Vitiligo Disease Activity Score (VIDA)
- Photography (before starting the treatment and every 2 weeks till the end of the study)
Laboratory evaluation:
- 2 mm punch skin biopsies will be taken from vitiligo patients, 1 from lesional and the other from perilesional skin before treatment.
- The patients will be randomly assigned to two groups:
Group A: patients will receive three NB-UVB sessions per week for 48 sessions. Group B: patients will receive three NB-UVB sessions per week for 48 sessions combined with acitretin in a dose of 0.3mg/kg/day daily.
- Controls: 20 individuals age and sex matched will be biopsied from the skin of their abdominoplasty surgery.
- Another two 2 mm punch skin biopsies will be taken from lesional and perilesional skin at the onset of repigmentation if repigmentation starts before completion of the 48 treatment session or after completion of the treatment period if repigmentation does not occur.
- .All biopsies from patients and controls will be stained Immunohistochemically by anti-E cadherin antibody.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two groups Group A: patients will receive three NB-UVB sessions per week for 48 sessions. Group B: patients will receive three NB-UVB sessions per week for 48 sessions combined with acitretin in a dose of 0.3 mg/kg/day daily.
| Arm | Type | Receives |
|---|---|---|
| NbUVB | Other | Other: Narrow band ultraviolet BGroup A: patients will receive three NB-UVB sessions per week for 48 sessions. |
| Combined nbUVB and Acitretin | Experimental | Drug: Acitretin, Other: Narrow band ultraviolet BGroup B: patients will receive three NB-UVB sessions per week for 48 sessions combined with acitretin in a dose of 0.3mg/kg/day daily. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients with generalized non-segmental vitiligo (25%-75%)
- Males, postmenopausal females and premenopausal females not planning to get pregnant during the period of treatment and after 2 years from the end of treatment.
- Age more than 18 years.
Key exclusion criteria (10 listed)
- Children ˂ 18 years old
- Pregnant females
- Premenopausal females planning to get pregnant within the period of treatment or within 2 years after.
- Patients receiving treatment for vitiligo within the past 2 months.
- Patients with abnormal liver profile
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 |
|---|---|---|
| AcitretinAlso: Acitretin 25Mg Cap, Acitretin 10Mg CapThe patients will receive the drug and the effect on repigmentation on vitiligo lesions will be observed | Drug | Combined nbUVB and Acitretin |
| Narrow band ultraviolet BPatients receive nbUVB session 3 times per week | Other | Combined nbUVB and Acitretin, NbUVB |
Primary outcome
Determining whether addition of acitretin is beneficial for vitiligo patients or not using Vitiligo Area Scoring Index
Time frame: 4-5 months
The number of patients who will achieve 100%, 75% and 50% repigmentation of vitiligo lesions will be compared between group A (nbUVB) and group B (nbUVB+ acitretin) after 48 nbUVB sessions. The comparison of the 2 groups will be assessed using Vitiligo Area Scoring Index (VASI)
Determining whether addition of acitretin is beneficial for vitiligo patients or not using Vitiligo Disease Activity Score.
Time frame: 4-5 months
The number of patients who will achieve 100%, 75% and 50% repigmentation of vitiligo lesions will be compared between group A (nbUVB) and group B (nbUVB+ acitretin) after 48 nbUVB sessions. The comparison of the 2 groups will be assessed using Vitiligo Disease Activity Score (VIDA).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2021.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acitretin and Narrow band ultraviolet B in people with Hyperlipidemias and Xerosis, run by Cairo 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 3 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: status not confirmed, as of the sponsor's last update on 22 Jul 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Noha A. Saleh, M.Sc (+201222177210, noushy2938@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determining whether addition of acitretin is beneficial for vitiligo patients or not using Vitiligo Area Scoring Index (time frame: 4-5 months). The study lists 2 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 22 Jul 2021.