Alopecia AreataNCT03847441
Topical Calcipotriol Versus Narrowband Ultraviolet B in Treatment of Alopecia Areata
A study testing Calcipotriol, Narrow Band UVB and vitamin D3 level in people with Alopecia Areata, run by Aswan University Hospital at 1 site in Egypt.
Trial summary
Alopecia Areata is a common condition. This study investigated the efficacy of calcipotriol versus Narrow Band Ultraviolet B in treatment of Alopecia areata and their effects on serum vitamin D3 levels. Read more about this study
- Who is it for?
- Ages 14 to 40 years
- Conditions the study is for
- Alopecia Areata
- What is being tested?
- Calcipotriol, Narrow Band UVB and vitamin D3 level
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2017to 31 Dec 2018
- 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 14 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Alopecia Areata of scalp
Who cannot join
- Other causes of alopecias including scarring alopecia, androgenic alopecia, telogen effluvium autoimmune diseases, pregnant and lactating females
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Topical Calcipotriol Versus Narrowband Ultraviolet B in Treatment of Alopecia Areata: A Randomized Controlled Trial
Alopecia Areata is a common condition. This study investigated the efficacy of calcipotriol versus Narrow Band Ultraviolet B in treatment of Alopecia areata and their effects on serum vitamin D3 levels.
- Conditions
- Alopecia Areata
- Being tested
- Calcipotriol, Narrow Band UVB, vitamin D3 level
- Keywords
- Alopecia Areata, Calcipotriol, Narrow Band-UVB, Vitamin D3
- Medical subject headings
- Alopecia Areata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CalcipotriolDrug
Calcipotriol ointment (0.005%)
Narrow Band UVBDevice
NB-UVB (311nm) phototherapy
vitamin D3 levelDiagnostic test
vitamin D3 (ng/ml)
| Study group | Role | What they receive |
|---|---|---|
| Group I | Active comparator | Not described Receives: Drug: Calcipotriol; Diagnostic Test: vitamin D3 level |
| Group II | Active comparator | Not described Receives: Device: Narrow Band UVB; Diagnostic Test: vitamin D3 level |
| Group III | Active comparator | Not described Receives: Drug: Calcipotriol; Device: Narrow Band UVB; Diagnostic Test: vitamin D3 level |
| Group IV | Placebo comparator | Not described Receives: Diagnostic Test: vitamin D3 level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical improvement of Alopecia Areata After treatment As assessed by Severity of Alopecia tool (SALT) score
calculation of SALT score before and after treatment
Measured: 3 months
Improvement of serum Vitamin D levels in (ng/ml) after treatment
measurement of serum vitamin D before and after treatment
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 posted20 Feb 2019
- Study start1 Oct 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alopecia AreataStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aswan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moustafa A. El Taieb, Aswan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03847441
- Sponsor's protocol ID
- Alopecia Calcipotiol
- Status last verified
- Mar 2019
- First submitted
- 18 Feb 2019
- Last updated
- 2 Apr 2019
- Results posted
- No
- 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 2 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Calcipotriol Versus Narrowband Ultraviolet B in Treatment of Alopecia Areata: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03847441
- Acronym / sponsor ID
- Alopecia Calcipotiol
- Conditions
- Alopecia Areata
- Keywords
- Alopecia Areata, Calcipotriol, Narrow Band-UVB, Vitamin D3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Aswan University HospitalUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 20 Feb 2019 (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.
Alopecia Areata is a common condition. This study investigated the efficacy of calcipotriol versus Narrow Band Ultraviolet B in treatment of Alopecia areata and their effects on serum vitamin D3 levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group I | Active comparator | Drug: Calcipotriol, Diagnostic Test: vitamin D3 level |
| Group II | Active comparator | Device: Narrow Band UVB, Diagnostic Test: vitamin D3 level |
| Group III | Active comparator | Drug: Calcipotriol, Device: Narrow Band UVB, Diagnostic Test: vitamin D3 level |
| Group IV | Placebo comparator | Diagnostic Test: vitamin D3 level |
Who may qualify
- Ages
- 14 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Alopecia Areata of scalp
Key exclusion criteria (1 listed)
- Other causes of alopecias including scarring alopecia, androgenic alopecia, telogen effluvium autoimmune diseases, pregnant and lactating females
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 |
|---|---|---|
| CalcipotriolCalcipotriol ointment (0.005%) | Drug | Group I, Group III |
| Narrow Band UVBNB-UVB (311nm) phototherapy | Device | Group II, Group III |
| vitamin D3 levelvitamin D3 (ng/ml) | Diagnostic test | Group I, Group II, Group III, Group IV |
Primary outcome
Clinical improvement of Alopecia Areata After treatment As assessed by Severity of Alopecia tool (SALT) score
Time frame: 3 months
calculation of SALT score before and after treatment
Improvement of serum Vitamin D levels in (ng/ml) after treatment
Time frame: 3 months
measurement of serum vitamin D before and after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2019.
- 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.
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 study testing Calcipotriol, Narrow Band UVB and vitamin D3 level in people with Alopecia Areata, run by Aswan University 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 1 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: finished, as of the sponsor's last update on 2 Apr 2019. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinical improvement of Alopecia Areata After treatment As assessed by Severity of Alopecia tool (SALT) score (time frame: 3 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 2 Apr 2019.