Alopecia AreataPhase 4NCT03535233
Topical 5% Minoxidil and Potent Topical Corticosteroid Versus Intralesional Corticosteroid in the Treatment of Alopecia Areata
A Phase 4 study testing Triamcinolone Acetonide, Minoxidil 5 % Topical Spray and clobetasol propionate in people with Alopecia Areata, run by Cairo University.
Trial summary
Alopecia areata (AA) presents with circumscribed patches of non-scarring hair loss. It inflects a significant psychological and social burden. Many treatment options are used for the treatment of AA. Randomized controlled trials comparing intralesional and topical therapy and comparing combinations are few. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alopecia Areata
- What is being tested?
- Triamcinolone Acetonide, Minoxidil 5 % Topical Spray and clobetasol propionate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Sep 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients presenting with scalp alopecia areata, patchy type, of at least 2 months duration.
Who cannot join
- Alopecia totalis and alopecia universalis.
- Alopecia areata solely affecting the beard.
- Pregnant and lactating.
- Patients known to have autoimmune diseases e.g. autoimmune thyroid disease, vitiligo or SLE.
- Patients receiving systemic treatment relevant to alopecia areata within 3 months before enrollment into the study or topical treatment relevant to alopecia areata within 2 months before.
- Patients with a dermatological condition affecting the scalp other than AA: e.g. psoriasis, eczema.
- Patients with psychiatric illness or psychological state interfering with compliance or influencing the expectation of the patient.
About this study
Official title: Combined Topical 5% Minoxidil and Potent Topical Corticosteroid Versus Intralesional Corticosteroid in the Treatment of Alopecia Areata A Randomized Controlled Trial
Alopecia areata (AA) presents with circumscribed patches of non-scarring hair loss. It inflects a significant psychological and social burden. Many treatment options are used for the treatment of AA. Randomized controlled trials comparing intralesional and topical therapy and comparing combinations are few.
The aim of this work is to evaluate the efficacy of combined topical 5% minoxidil and potent topical corticosteroid therapy compared to intralesional triamcinolone injection in alopecia areata
- Conditions
- Alopecia Areata
- Being tested
- Triamcinolone Acetonide, Minoxidil 5 % Topical Spray, clobetasol propionate
- Keywords
- Alopecia areata, intralesional corticosteroid, minoxidil, clobetasol propionate, IL-23, TGFβ-1
- 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
Minoxidil 5 % Topical SprayDrug
clobetasol propionateDrug
| Study group | Role | What they receive |
|---|---|---|
| Intralesional group | Active comparator | intralesional triamcinolone acetonide 5 mg/ml monthly Receives: Drug: Triamcinolone Acetonide |
| Topical therapy group | Active comparator | Minoxidil 5% topical solution applied twice daily and topical clobetasol propionate 0.05% cream applied once daily every night Receives: Drug: Minoxidil 5 % Topical Spray; Drug: clobetasol propionate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical assessment using SALT score (Severity of Alopecia Tool score)
SALT score is a quantitative assessment scale for the evaluation of percentage of scalp hair loss.
The percent surface area of each of the 4 scalp is determined: Vertex (top): 40% (0.4) of scalp surface area; each side of scalp (right and left profile): each 18% (0.18) of scalp surface area; posterior aspect (back) of scalp: 24% (0.24) of scalp surface area. The percentage of hair loss in any of these 4 aspects is calculated as the percentage of hair loss multiplied by percent surface area of the scalp in that area. SALT score is the sum of product of each section in the above mentioned areas. SALT score is calculated before and after therapy.
Lowest value: 0%: indicates abscence of clinical disease, Highest value: 100%: indicate 100% affection of the scalp
Measured: 3 months
Secondary outcomes (3)
Dermoscopic evaluation
Dermoscopic assessment of the scalp is performed using DermaLite II Pro HR dermoscope, Germany.
Dermoscopic examination is graded according to a scale provided by Trink and colleagues (2013).
The percentage of dystrophic hairs was evaluated on a 4-point scale as followed:
- 3= >50% dystrophic hairs
- 2 = 30-50% dystrophic hairs
- 1 = 1-29% dystrophic hairs
- 0 = no dystrophic hairs
Measured: 3 months
Quantitative measurement of Transforming growth factor-beta 1 (TGF-β1)
ELISA
Measured: 3 months
Quantitative measurement of Interleukin-23 (IL-23)
ELISA
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 posted24 May 2018
- Study startMar 2016
- Primary completionJun 2017
- Study completionSep 2017
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 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona El-Kalioby, Cairo University
- Investigators
- Nermine H El-Eishi, MD, Study chair, Cairo UniversityHeba M Mashaly, MD, Principal investigator, Cairo UniversitySolwan I El-Samanoudy, MD, Principal investigator, Cairo UniversityMona MI ElKalioby, MD, Principal investigator, Cairo UniversityOlfat G Shaker, MD, Principal investigator, Cairo UniversityRania M Abdel-Hay, MD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03535233
- Sponsor's protocol ID
- AA22
- Status last verified
- May 2018
- First submitted
- 11 May 2018
- Last updated
- 24 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Topical 5% Minoxidil and Potent Topical Corticosteroid Versus Intralesional Corticosteroid in the Treatment of Alopecia Areata A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03535233
- Acronym / sponsor ID
- AA22
- Conditions
- Alopecia Areata
- Keywords
- Alopecia areata, intralesional corticosteroid, minoxidil, clobetasol propionate, IL-23, TGFβ-1
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 24 May 2018 (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 (AA) presents with circumscribed patches of non-scarring hair loss. It inflects a significant psychological and social burden. Many treatment options are used for the treatment of AA. Randomized controlled trials comparing intralesional and topical therapy and comparing combinations are few.
The aim of this work is to evaluate the efficacy of combined topical 5% minoxidil and potent topical corticosteroid therapy compared to intralesional triamcinolone injection in alopecia areata
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intralesional group | Active comparator | Drug: Triamcinolone Acetonideintralesional triamcinolone acetonide 5 mg/ml monthly |
| Topical therapy group | Active comparator | Drug: Minoxidil 5 % Topical Spray, Drug: clobetasol propionateMinoxidil 5% topical solution applied twice daily and topical clobetasol propionate 0.05% cream applied once daily every night |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients presenting with scalp alopecia areata, patchy type, of at least 2 months duration.
Key exclusion criteria (7 listed)
- Alopecia totalis and alopecia universalis.
- Alopecia areata solely affecting the beard.
- Pregnant and lactating.
- Patients known to have autoimmune diseases e.g. autoimmune thyroid disease, vitiligo or SLE.
- Patients receiving systemic treatment relevant to alopecia areata within 3 months before enrollment into the study or topical treatment relevant to alopecia areata within 2 months before.
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 Acetonide | Drug | Intralesional group |
| Minoxidil 5 % Topical Spray | Drug | Topical therapy group |
| clobetasol propionate | Drug | Topical therapy group |
Primary outcome
Clinical assessment using SALT score (Severity of Alopecia Tool score)
Time frame: 3 months
SALT score is a quantitative assessment scale for the evaluation of percentage of scalp hair loss. The percent surface area of each of the 4 scalp is determined: Vertex (top): 40% (0.4) of scalp surface area; each side of scalp (right and left profile): each 18% (0.18) of scalp surface area; posterior aspect (back) of scalp: 24% (0.24) of scalp surface area. The percentage of hair loss in any of these 4 aspects is calculated as the percentage of hair loss multiplied by percent surface area of the scalp in that area. SALT score is the sum of product of each section in the above mentioned areas. SALT score is calculated before and after therapy. Lowest value: 0%: indicates abscence of clinical disease, Highest value: 100%: indicate 100% affection of the scalp
3 secondary outcomes
Dermoscopic evaluation
Time frame: 3 months
Quantitative measurement of Transforming growth factor-beta 1 (TGF-β1)
Time frame: 3 months
Quantitative measurement of Interleukin-23 (IL-23)
Time frame: 3 months
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 24 May 2018.
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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.
Nermine H El-Eishi, MD study chair
Cairo University
Heba M Mashaly, MD principal investigator
Cairo University
Solwan I El-Samanoudy, MD principal investigator
Cairo University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Triamcinolone Acetonide, Minoxidil 5 % Topical Spray and clobetasol propionate in people with Alopecia Areata, run by Cairo University.
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 7 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 24 May 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
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 assessment using SALT score (Severity of Alopecia Tool score) (time frame: 3 months). 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 24 May 2018.