Alopecia AreataPhase 1NCT05885269
Comparative Efficacy of Tacrolimus and Clobetasol Propionate in Alopecia Areata
A Phase 1 study testing Group A applied topical Clobetasol Propionate and Group B applied topical Tacrolimus in people with Alopecia Areata, run by Combined Military Hospital Abbottabad at 1 site in Pakistan.
Trial summary
Methodology: The 70 patients of age 20 to 50 years presented to the out-patient department of CMH Abbottabad suffering from alopecia areata were enrolled. The non-probability consecutive sampling technique was used. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Alopecia Areata
- What is being tested?
- Group A applied topical Clobetasol Propionate and Group B applied topical Tacrolimus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Nov 2022to 30 Apr 2023
- Phase
- Phase 1
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients age 20 to 50 years
- Both male and female
- Duration of illness less than 2 months
- those who never received any treatment before
Who cannot join
- Patients having duration of alopecia greater than 2 months
- Atypical alopecia areata i.e., Alopecia universalis etc
- Hypersensitivity history to topical corticosteroids or tacrolimus
- patients taking any systemic immune suppression
- pregnancy/lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Efficacy of Tacrolimus 0.1% and Clobetasol Propionate 0.05% in the Treatment of Alopecia Areata
Methodology: The 70 patients of age 20 to 50 years presented to the out-patient department of CMH Abbottabad suffering from alopecia areata were enrolled. The non-probability consecutive sampling technique was used. Patient in group-A applied clobetasol propionate 0.05% twice daily, whereas Group-B applied topical tacrolimus 0.1% twice daily for upto 3 months. The Patients were assessed at baseline, 4th weeks, 8th week and 12th week after treatment of each session. Hair loss was calculated from SALT score at presentation and on follow-up after 3 months. The degree of response was assessed on the basis of hair re-growth as excellent (>75% re-growth), Marked (51-75% re-growth), moderate (26-50% re-growth), or slight (≤25% re-growth). To determine statistical significance χ2-square test, taking p-value <0.05 as significant, was used.
- Conditions
- Alopecia Areata
- Being tested
- Group A applied topical Clobetasol Propionate, Group B applied topical Tacrolimus
- Medical subject headings
- Alopecia Areata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group A applied topical Clobetasol PropionateDrug
Patient in group-A applied clobetasol propionate 0.05% twice daily for upto 03 months
Group B applied topical TacrolimusDrug
Group-B applied topical tacrolimus 0.1% twice daily for upto 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Group A applied Clobetasol Propionate 0.05% | Active comparator | Patient in group-A applied clobetasol propionate 0.05% twice daily for upto 03 months. Receives: Drug: Group A applied topical Clobetasol Propionate |
| Group B applied topical Tacrolimus 0.1% | Active comparator | Group-B applied topical tacrolimus 0.1% twice daily for upto 3 months. Receives: Drug: Group B applied topical Tacrolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
The degree of response was assessed on The basis of hair regrowth as excellent, marked, moderate or slight.
The degree of response was assessed on the basis of hair regrowth as excellent (>75% regrowth), marked (51-75% regrowth), moderate (26-50% regrowth), or slight (≤25% regrowth)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study start1 Nov 2022
- Primary completion30 Apr 2023
- Study completion30 Apr 2023
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Combined Military Hospital Abbottabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, danyal sajjad, Combined Military Hospital Abbottabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05885269
- Sponsor's protocol ID
- CMHAbbottabad2021
- Status last verified
- May 2023
- First submitted
- 19 May 2023
- Last updated
- 1 Jun 2023
- 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 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy of Tacrolimus 0.1% and Clobetasol Propionate 0.05% in the Treatment of Alopecia Areata
- ClinicalTrials.gov ID
- NCT05885269
- Acronym / sponsor ID
- CMHAbbottabad2021
- Conditions
- Alopecia Areata
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Combined Military Hospital AbbottabadUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 1 Jun 2023 (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.
Methodology: The 70 patients of age 20 to 50 years presented to the out-patient department of CMH Abbottabad suffering from alopecia areata were enrolled. The non-probability consecutive sampling technique was used. Patient in group-A applied clobetasol propionate 0.05% twice daily, whereas Group-B applied topical tacrolimus 0.1% twice daily for upto 3 months. The Patients were assessed at baseline, 4th weeks, 8th week and 12th week after treatment of each session. Hair loss was calculated from SALT score at presentation and on follow-up after 3 months. The degree of response was assessed on the basis of hair re-growth as excellent (>75% re-growth), Marked (51-75% re-growth), moderate (26-50% re-growth), or slight (≤25% re-growth). To determine statistical significance χ2-square test, taking p-value <0.05 as significant, was used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A applied Clobetasol Propionate 0.05% | Active comparator | Drug: Group A applied topical Clobetasol PropionatePatient in group-A applied clobetasol propionate 0.05% twice daily for upto 03 months. |
| Group B applied topical Tacrolimus 0.1% | Active comparator | Drug: Group B applied topical TacrolimusGroup-B applied topical tacrolimus 0.1% twice daily for upto 3 months. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients age 20 to 50 years
- Both male and female
- Duration of illness less than 2 months
- those who never received any treatment before
Key exclusion criteria (5 listed)
- Patients having duration of alopecia greater than 2 months
- Atypical alopecia areata i.e., Alopecia universalis etc
- Hypersensitivity history to topical corticosteroids or tacrolimus
- patients taking any systemic immune suppression
- pregnancy/lactation
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 |
|---|---|---|
| Group A applied topical Clobetasol PropionatePatient in group-A applied clobetasol propionate 0.05% twice daily for upto 03 months | Drug | Group A applied Clobetasol Propionate 0.05% |
| Group B applied topical TacrolimusGroup-B applied topical tacrolimus 0.1% twice daily for upto 3 months. | Drug | Group B applied topical Tacrolimus 0.1% |
Primary outcome
The degree of response was assessed on The basis of hair regrowth as excellent, marked, moderate or slight.
Time frame: 6 months
The degree of response was assessed on the basis of hair regrowth as excellent (>75% regrowth), marked (51-75% regrowth), moderate (26-50% regrowth), or slight (≤25% regrowth)
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 1 Jun 2023.
- 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 Phase 1 study testing Group A applied topical Clobetasol Propionate and Group B applied topical Tacrolimus in people with Alopecia Areata, run by Combined Military Hospital Abbottabad at 1 site in Pakistan.
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 4 inclusion and 5 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 1 Jun 2023. 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 Pakistan. 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 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.
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?
The degree of response was assessed on The basis of hair regrowth as excellent, marked, moderate or slight. (time frame: 6 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 1 Jun 2023.