Alopecia AreataPhase 1/2NCT04660786
Intralesional Vitamin D in Alopecia Areata
A Phase 1/2 study testing triamcinolone acetonide and vitamin D in people with Alopecia Areata, run by Alexandria University at 1 site in Egypt.
Trial summary
To evaluate the efficacy and safety of intralesional injection of vitamin D3 versus intralesional injection of corticosteroids in treatment of alopecia areata. this will be carried out on 40 patients who attend hair outpatient clinic, department of dermatology, Faculty of medicine, Alexandria University, Egypt. Read more about this study
- Who is it for?
- Ages 10 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alopecia Areata
- What is being tested?
- triamcinolone acetonide and vitamin D
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2021to 1 Dec 2022
- Phase
- Phase 1/2
- 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 10 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Site: scalp. Extent: localized alopecia areata (less than 50% scalp involvement).
Who cannot join
- Other skin diseases affecting the scalp
- Pregnant or lactating women.
- Bleeding or coagulation disorders
- Immunocompromised patients.
- Known hypersensitivity to vitamin D3.
- Patients who received systemic or topical treatment for alopecia areata in the last month.
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- Patients taking vitamin D supplements in the last 6 months.
- Patients treated with topical vitamin D analogues.
- Patients with diseases known to alter vitamin D level as autoimmune diseases, liver or renal diseases.
- Obesity (defined as body mass index ≥ 25).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intralesional Vitamin D3 Injection in Treatment of Alopecia Areata: A Novel Approach
To evaluate the efficacy and safety of intralesional injection of vitamin D3 versus intralesional injection of corticosteroids in treatment of alopecia areata.
this will be carried out on 40 patients who attend hair outpatient clinic, department of dermatology, Faculty of medicine, Alexandria University, Egypt.
The patients will be randomly assigned into two groups (A and B), each group contains 20 patients. Patients will be blindly subjected to intralesional injection of triamcinolone acetonide (5mg/ml) using sterile saline for dilution every 4 weeks for 3 sessions (11,12) or intralesional injection of vitamin D (an aqueous preparation of cholecalciferol (Devarol® ampoule 200,000 IU/2 mL, Memphis, Egypt) (2.5 mg/mL) every 4 weeks for 3 sessions. The maximum total amount of vitamin D3 injected into a patient in 1 session will be 5 mg Injection will be preceded by topical anaesthesia under occlusion for 30 minutes.
- Conditions
- Alopecia Areata
- Being tested
- triamcinolone acetonide, vitamin D
- Medical subject headings
- Alopecia Areata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
triamcinolone acetonideDrug
local immunosuprresent
vitamin DDrug
local immunomodulator
| Study group | Role | What they receive |
|---|---|---|
| intralesional injection of triamcinolone acetonide | Active comparator | 5mg/ml) using sterile saline for dilution every 4 weeks for 3 sessions Receives: Drug: triamcinolone acetonide |
| intralesional injection of vitamin D | Active comparator | (2.5 mg/mL) every 4 weeks for 3 sessions Receives: Drug: vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regrowth Score (RGS)
calculation at week 12 using a 5-point semiquantitative score (RGS)(0 = regrowth < 10%; 1 = regrowth 11- 25%; 2 = regrowth26 - 50%; 3 = regrowth 51- 75%; 4: regrowth > 75%)
Measured: three month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2020
- Study start1 Nov 2021 (estimated)
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
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.
- More trials run by Alexandria 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, marwa eldeeb, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04660786
- Sponsor's protocol ID
- 0304857
- Status last verified
- Jul 2021
- First submitted
- 3 Dec 2020
- Last updated
- 26 Jul 2021
- 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 26 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intralesional Vitamin D3 Injection in Treatment of Alopecia Areata: A Novel Approach
- ClinicalTrials.gov ID
- NCT04660786
- Acronym / sponsor ID
- 0304857
- Conditions
- Alopecia Areata
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (estimated)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 9 Dec 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.
To evaluate the efficacy and safety of intralesional injection of vitamin D3 versus intralesional injection of corticosteroids in treatment of alopecia areata.
this will be carried out on 40 patients who attend hair outpatient clinic, department of dermatology, Faculty of medicine, Alexandria University, Egypt.
The patients will be randomly assigned into two groups (A and B), each group contains 20 patients. Patients will be blindly subjected to intralesional injection of triamcinolone acetonide (5mg/ml) using sterile saline for dilution every 4 weeks for 3 sessions (11,12) or intralesional injection of vitamin D (an aqueous preparation of cholecalciferol (Devarol® ampoule 200,000 IU/2 mL, Memphis, Egypt) (2.5 mg/mL) every 4 weeks for 3 sessions. The maximum total amount of vitamin D3 injected into a patient in 1 session will be 5 mg Injection will be preceded by topical anaesthesia under occlusion for 30 minutes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intralesional injection of triamcinolone acetonide | Active comparator | Drug: triamcinolone acetonide5mg/ml) using sterile saline for dilution every 4 weeks for 3 sessions |
| intralesional injection of vitamin D | Active comparator | Drug: vitamin D(2.5 mg/mL) every 4 weeks for 3 sessions |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Site: scalp. Extent: localized alopecia areata (less than 50% scalp involvement).
Key exclusion criteria (10 listed)
- Other skin diseases affecting the scalp
- Pregnant or lactating women.
- Bleeding or coagulation disorders
- Immunocompromised patients.
- Known hypersensitivity to vitamin D3.
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 |
|---|---|---|
| triamcinolone acetonidelocal immunosuprresent | Drug | intralesional injection of triamcinolone acetonide |
| vitamin Dlocal immunomodulator | Drug | intralesional injection of vitamin D |
Primary outcome
Regrowth Score (RGS)
Time frame: three month
calculation at week 12 using a 5-point semiquantitative score (RGS)(0 = regrowth < 10%; 1 = regrowth 11- 25%; 2 = regrowth26 - 50%; 3 = regrowth 51- 75%; 4: regrowth > 75%)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 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 Phase 1/2 study testing triamcinolone acetonide and vitamin D in people with Alopecia Areata, run by Alexandria 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 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 26 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact marwa eldeeb (01200029774, marwa.eldeeb16@alexmed.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regrowth Score (RGS) (time frame: three month). 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 26 Jul 2021.