Alopecia AreataPhase 2NCT02561585
LEO 124249 Ointment in the Treatment of Alopecia Areata
A Phase 2 study testing LEO 124249 in people with Alopecia Areata, run by LEO Pharma at 2 sites in United States.
Trial summary
This clinical trial attempts to investigate the efficacy and safety of LEO 124249 ointment in the treatment of alopecia areata and the molecular disease mechanism and biomarkers. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alopecia Areata
- What is being tested?
- LEO 124249
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2016to Dec 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must have signed and dated informed consent after receiving verbal and written information about the clinical trial.
- Subjects with unequivocal clinical diagnosis of moderate to severe scalp alopecia areata (patch type, totalis, universalis), as determined by the (sub) investigator, affecting a minimum of 30% scalp area at Visit 1 (Screening) and Visit 2 (Day 1, baseline).
- Minimum 6 month duration of hair loss at Visit 1 (Screening). No upper limit time limit.
- Subject must accept to not cut hair in the treated scalp areas during the trial.
Who cannot join
- Females who are pregnant or are breast feeding.
- Current signs of spontaneous hair regrowth.
- Diffuse type alopecia areata.
- Co-existing moderate to severe androgenic alopecia (Norwood-Hamilton stage IV-VI and Ludwig stage II and III)
- Subjects with changed or expected changes in medication for thyroid disease within 6 month before Visit 1 (screening) or during the trial.
- Systemic treatment with immunosuppressive drugs (e.g. methotrexate, cyclosporine, azathioprine), chloroquin derivatives, corticosteroids, or any other systemic therapy that in the opinion of the investigator could affect hair regrowth, within 6 weeks prior to randomization (inhaled or intra-nasal steroids corresponding to up to 1 mg prednisone for asthma or rhinitis may be used).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Northwestern University
Evanston, Illinois, 60208
The Icahn School of Medicine, Mount Sinai Hospital
New York, New York, 10029
About this study
Official title: Efficacy of Twice Daily Applications of LEO 124249 Ointment 30mg/g for 12 Weeks to Subjects With Alopecia Areata
This clinical trial attempts to investigate the efficacy and safety of LEO 124249 ointment in the treatment of alopecia areata and the molecular disease mechanism and biomarkers.
Read the detailed description
The objectives of this clinical trial are to compare the efficacy of twice-daily topical LEO 124249 30 mg/g ointment with LEO 124249 ointment vehicle for 12 weeks in the treatment of hair loss in subjects with alopecia areata, to evaluate the safety of this treatment, to evaluate hair regrowth, to determine subject quality of life, and to explore disease mechanism and its biomarkers.
- Conditions
- Alopecia Areata
- Being tested
- LEO 124249, Vehicle
- Medical subject headings
- Alopecia Areata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEO 124249Drug
Also called LEO 124249 Ointment
VehicleOther
Also called LEO 124249 Vehicle
| Study group | Role | What they receive |
|---|---|---|
| LEO 124249 | Experimental | LEO 124249 ointment 30 mg/g twice daily Receives: Drug: LEO 124249 |
| Vehicle | Placebo comparator | LEO 124249 ointment vehicle twice daily Receives: Other: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Severity of Alopecia Areata Tool (SALT) Score
The SALT score indicates the sum area of scalp with hair loss and ranges from 0 - 100 (min-max), with higher scores indicating more hair loss. A negative change in SALT score indicates lesser (improvement) hair loss while positive high scores indicate more (worsening) hair loss.
Measured: From baseline (Day 1) to Week 12 (Day 84)
Secondary outcomes (13)
Summary of Absolute SALT Score
The SALT (Severity of Alopecia Areata Tool) score indicates the sum area of scalp with hair loss and ranges from 0 - 100 (min-max), with higher scores indicating more hair loss.
Summary of observed values of the absolute SALT score.
Measured: At baseline (Day 1), Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84)
Summary of Change in SALT Score
The SALT (Severity of Alopecia Areata Tool) score indicates the sum area of scalp with hair loss and ranges from 0 - 100 (min-max), with higher scores indicating more hair loss. A negative change in SALT score indicates lesser (improvement) hair loss while positive high scores indicate more (worsening) hair loss.
Measured: From baseline (Day 1) to Week 4 (Day 28), Week 8 (Day 56), and Week 12 (Day 84)
Summary of Relative Change in SALT Score
The SALT (Severity of Alopecia Areata Tool) score indicates the sum area of scalp with hair loss and ranges from 0 - 100 (min-max), with higher scores indicating more hair loss. A negative change in SALT score indicates lesser (improvement) hair loss while positive high scores indicate more (worsening) hair loss.
Measured: From baseline (Day 1) to Week 4 (Day 28), Week 8 (Day 56), and Week 12 (Day 84)
Percentage of Patients Who Achieve 50% Improvement in the SALT Score
The event of having at least 50% reduction in SALT score at Week 12 (Day 84) as compared to baseline (Day 1)
Measured: At Week 12 (Day 84)
Hair Length
Hair length measured in millimeters.
Measured: At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84)
Hair Growth Rate
Change in hair length measured in millimeters per day.
Measured: At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84)
Relative Hair Thickness
Thickness relative to participant's normal scalp hair. Relative assessment not applicable for participants with alopecia areata totalis and universalis.
Measured: At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84)
Hair Type
Hair type being either vellus hair or terminal hair. Hair type is not applicable for participants with alopecia areata totalis and universalis.
Measured: At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84)
Hair Color
Absolute color of hair. Hair color is not applicable for alopecia areata totalis and universalis.
Measured: At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84)
Global Assessment of Overall Hair Regrowth Compared to Baseline
Based on standardized photographs
Measured: At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84)
Participant's Global Assessment of Hair Regrowth
The participant will assess the hair regrowth before the investigator does any assessments of hair regrowth.
Measured: At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84)
Subcategory and Total Score of the Alopecia Areata Quality of Life Questionnaire (AA-QLI)
The scale includes 21 questions measuring the degree to which the patient was affected by the AA in the last month, scored from 1 (not affected at all) to 4 (highly affected).
The AA-QLI transformed scores for each of the subcategories 'subjective symptoms', 'relationship' and 'objective signs' ranging from (min-max) 9-36, 9-36, and 3-12. Total score ranges from 0-84.
Low score indicating that the participant was least affected by AA.
Measured: At baseline (Day 1) and at Week 12 (Day 84)
Treatment Satisfaction Questionnaire for Medication Score
The Treatment Satisfaction Questionnaire for Medication (TSQM II) is a validated, general measure of treatment satisfaction for medication - accounting for effectiveness, side effects, convenience, and global satisfaction - that is comparable across medication types and patient conditions.
The individual derived score for each of the 4 dimensions (effectiveness, side effects, convenience, and global satisfaction) of the TSQM II questionnaire ranged from 0-100, with a higher score indicating greater satisfaction to treatment.
Measured: At Week 12 (Day 84)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2015 (estimated)
- Study startJan 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Emma Guttman, MD, PhD, Principal investigator, The Icahn School of Medicine, Mount Sinai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02561585
- Sponsor's protocol ID
- EXP-1222
- Status last verified
- Feb 2019
- First submitted
- 25 Sep 2015
- Last updated
- 6 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Twice Daily Applications of LEO 124249 Ointment 30mg/g for 12 Weeks to Subjects With Alopecia Areata
- ClinicalTrials.gov ID
- NCT02561585
- Acronym / sponsor ID
- EXP-1222
- Conditions
- Alopecia Areata
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- Jan 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 28 Sep 2015 (estimated)
- Results
- Posted 16 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial attempts to investigate the efficacy and safety of LEO 124249 ointment in the treatment of alopecia areata and the molecular disease mechanism and biomarkers.
Detailed description
The objectives of this clinical trial are to compare the efficacy of twice-daily topical LEO 124249 30 mg/g ointment with LEO 124249 ointment vehicle for 12 weeks in the treatment of hair loss in subjects with alopecia areata, to evaluate the safety of this treatment, to evaluate hair regrowth, to determine subject quality of life, and to explore disease mechanism and its biomarkers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LEO 124249 | Experimental | Drug: LEO 124249LEO 124249 ointment 30 mg/g twice daily |
| Vehicle | Placebo comparator | Other: VehicleLEO 124249 ointment vehicle twice daily |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects must have signed and dated informed consent after receiving verbal and written information about the clinical trial.
- Subjects with unequivocal clinical diagnosis of moderate to severe scalp alopecia areata (patch type, totalis, universalis), as determined by the (sub) investigator, affecting a minimum of 30% scalp area at Visit 1 (Screening) and Visit 2 (Day 1, baseline).
- Minimum 6 month duration of hair loss at Visit 1 (Screening). No upper limit time limit.
- Subject must accept to not cut hair in the treated scalp areas during the trial.
Key exclusion criteria (6 listed)
- Females who are pregnant or are breast feeding.
- Current signs of spontaneous hair regrowth.
- Diffuse type alopecia areata.
- Co-existing moderate to severe androgenic alopecia (Norwood-Hamilton stage IV-VI and Ludwig stage II and III)
- Subjects with changed or expected changes in medication for thyroid disease within 6 month before Visit 1 (screening) or during the trial.
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 |
|---|---|---|
| LEO 124249Also: LEO 124249 Ointment | Drug | LEO 124249 |
| VehicleAlso: LEO 124249 Vehicle | Other | Vehicle |
Primary outcome
Change in Severity of Alopecia Areata Tool (SALT) Score
Time frame: From baseline (Day 1) to Week 12 (Day 84)
The SALT score indicates the sum area of scalp with hair loss and ranges from 0 - 100 (min-max), with higher scores indicating more hair loss. A negative change in SALT score indicates lesser (improvement) hair loss while positive high scores indicate more (worsening) hair loss.
13 secondary outcomes
Summary of Absolute SALT Score
Time frame: At baseline (Day 1), Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84)
Summary of Change in SALT Score
Time frame: From baseline (Day 1) to Week 4 (Day 28), Week 8 (Day 56), and Week 12 (Day 84)
Summary of Relative Change in SALT Score
Time frame: From baseline (Day 1) to Week 4 (Day 28), Week 8 (Day 56), and Week 12 (Day 84)
Percentage of Patients Who Achieve 50% Improvement in the SALT Score
Time frame: At Week 12 (Day 84)
Hair Length
Time frame: At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84)
Hair Growth Rate
Time frame: At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84)
Relative Hair Thickness
Time frame: At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84)
Hair Type
Time frame: At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84)
Hair Color
Time frame: At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84)
Global Assessment of Overall Hair Regrowth Compared to Baseline
Time frame: At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84)
Participant's Global Assessment of Hair Regrowth
Time frame: At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84)
Subcategory and Total Score of the Alopecia Areata Quality of Life Questionnaire (AA-QLI)
Time frame: At baseline (Day 1) and at Week 12 (Day 84)
Treatment Satisfaction Questionnaire for Medication Score
Time frame: At Week 12 (Day 84)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Clinical Trials at LEO PharmaLink provided by the sponsor.
- 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.
Emma Guttman, MD, PhD principal investigator
The Icahn School of Medicine, Mount Sinai Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LEO 124249 in people with Alopecia Areata, run by LEO Pharma at 2 sites in United States.
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 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: finished, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 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?
Yes. Results are posted in the registry (first posted 16 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Severity of Alopecia Areata Tool (SALT) Score (time frame: From baseline (Day 1) to Week 12 (Day 84)). 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 6 Mar 2025; AzTrials last refreshed its copy on 8 Nov 2026.