Alopecia AreataPhase 4NCT04412148
Modified SALT Score for Alopecia Areata
A Phase 4 study testing Triamcinolone Acetonide and saline in people with Alopecia Areata, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
Patchy Alopecia areata was treated by intralesional steroids for 3 months and was evaluated by percentage of involvement, mSALT score and dermoscopy. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Alopecia Areata
- What is being tested?
- Triamcinolone Acetonide and saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2020to 1 Aug 2020
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- localized scalp AA ( 2 patches and ≤50% scalp involvement , duration more than 6 months) • patients who did not receive any medication for at least 2 months before starting the study and those who agreed to join the study and signed written consent.
Who cannot join
- • pregnant, and lactating females
- Alopecia totalis or universalis or ophiasis or cicatritial alopecia
- Usage of systemic treatment of alopecia areata 2 months prior to the study.
- Any scalp lesion within the treated area
- Bleeding diathesis, severe anemia or platelet disorders
- Medical conditions such as autoimmune diseases.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Kasr El Ainy university hospital, Faulty of medicine,Cairo university
Cairo
Rana Hilal, MD, 1001488869 ext. +20, rana.hilal@kasralainy.edu.eg
About this study
Official title: Modified SALT Score for Assessment of Alopecia Areata
Patchy Alopecia areata was treated by intralesional steroids for 3 months and was evaluated by percentage of involvement, mSALT score and dermoscopy.
- Conditions
- Alopecia Areata
- Being tested
- Triamcinolone Acetonide, saline
- 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
intralesional injection of triamcinolone acetonide every 2 weeks for 6 sessions
salineOther
intralesional injection of saline
| Study group | Role | What they receive |
|---|---|---|
| Intralesional Steroids | Active comparator | Not described Receives: Drug: Triamcinolone Acetonide |
| Control | Placebo comparator | Not described Receives: Other: saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage involvement
Degree of severity expressed as a percentage
Measured: 6months to 1 year
Modified Severity of Alopecia Tool (mSALT) score
New Score calculating severity (hair density) and area as a number minimum value is 0 and maximum value is 105 the higher the number of the score the worse the affection
Measured: 6 months to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2020
- Study start1 Jan 2020
- Primary completion1 Jul 2020 (estimated)
- Study completion1 Aug 2020 (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.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
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
- NCT04412148
- Sponsor's protocol ID
- EgymSALT
- Status last verified
- May 2020
- First submitted
- 29 May 2020
- Last updated
- 2 Jun 2020
- 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 2 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified SALT Score for Assessment of Alopecia Areata
- ClinicalTrials.gov ID
- NCT04412148
- Acronym / sponsor ID
- EgymSALT
- Conditions
- Alopecia Areata
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jul 2020 (estimated)
- Study completion
- 1 Aug 2020 (estimated)
- First posted
- 2 Jun 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.
Patchy Alopecia areata was treated by intralesional steroids for 3 months and was evaluated by percentage of involvement, mSALT score and dermoscopy.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intralesional Steroids | Active comparator | Drug: Triamcinolone Acetonide |
| Control | Placebo comparator | Other: saline |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- localized scalp AA ( 2 patches and ≤50% scalp involvement , duration more than 6 months) • patients who did not receive any medication for at least 2 months before starting the study and those who agreed to join the study and signed written consent.
Key exclusion criteria (6 listed)
- • 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 |
|---|---|---|
| Triamcinolone Acetonideintralesional injection of triamcinolone acetonide every 2 weeks for 6 sessions | Drug | Intralesional Steroids |
| salineintralesional injection of saline | Other | Control |
Primary outcome
Percentage involvement
Time frame: 6months to 1 year
Degree of severity expressed as a percentage
Modified Severity of Alopecia Tool (mSALT) score
Time frame: 6 months to 1 year
New Score calculating severity (hair density) and area as a number minimum value is 0 and maximum value is 105 the higher the number of the score the worse the affection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2020.
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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 4 study testing Triamcinolone Acetonide and saline in people with Alopecia Areata, 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 6 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 2 Jun 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rana Hilal, MD (1001488869 ext. +20, rana.hilal@kasralainy.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage involvement (time frame: 6months to 1 year). 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 Jun 2020.