Alopecia AreataPhase 2NCT03325296
Efficacy of Twice Daily Application of LEO 124249 Ointment 30 mg/g for 12 Weeks on Eyebrow Alopecia Areata.
A Phase 2 study testing LEO 124249 in people with Alopecia Areata, run by LEO Pharma at 2 sites in Denmark.
Trial summary
This clinical trial attempts to investigate the efficacy of LEO 124249 ointment in the treatment of alopecia areata on the eyebrows. 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
- 13 participants
- Where
- 2 sitesDenmark
- Study dates
- 30 Oct 2017to 16 May 2018
- Phase
- Phase 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical unequivocal diagnosis of Alopecia Areata (patchy, univeralis and totalis), on both scalp and eyebrows as assessed by the investigator.
- Maximal disease duration of current episode of Alopecia Areata on the eyebrows of 3 years at screening.
- Maximal Alopecia Areata disease duration - defined as years of active disease - in other locations than eyebrows of 10 years at screening.
Who cannot join
- Clinical diagnosis of diffuse type alopecia areata as assessed by the investigator.
- Any topical, intralesional therapy or procedure applied within 2 cm of the treatment area, within 4 weeks of randomisation, which in the opinion of the investigator, could interfere with the trial assessments. This includes, but is not limited to: corticosteroids, calcineurin inhibitors, calcipotriol, minoxidil, antimicrobials, prostaglandin analogs (e.g. bimatoprost), herbal extracts, topical immunotherapy with allergens or irritants and any laser or phototherapy, and eyebrow tattoo.
- Any systemic treatment with immunosuppressive drugs (e.g. methotrexate, cyclosporine, azathioprine), chloroquin derivatives, corticosteroids (including intralesional treatment outside the trial treatment area), or any other systemic therapy that in the opinion of the investigator could affect hair regrowth, within 4 weeks prior to randomisation.
- Any biologic medicinal product targeting the immune system within 5 half-lives and minimum 4 weeks prior to randomisation (e.g. anti-TNFα, anti-IL17, anti IL12/23, anti IL-4Rα targeting drugs).
- Systemic JAK inhibitor Ruxolitinib (Jakafi®/Jakavi®), Tofacitinib (Xeljanz®) at any time prior to randomisation.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Investigational site
Aarhus, 8000
Investigational site
Gentofte Municipality, 2820
About this study
This clinical trial attempts to investigate the efficacy of LEO 124249 ointment in the treatment of alopecia areata on the eyebrows.
- Conditions
- Alopecia Areata
- Being tested
- LEO 124249, Ointment 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
Ointment containing LEO 124249
Ointment vehicleOther
Ointment without active ingredients
| Study group | Role | What they receive |
|---|---|---|
| LEO 124249 ointment 30 mg/g | Experimental | Ointment to be applied on the eyebrow twice daily. Receives: Drug: LEO 124249 |
| LEO 124249 ointment vehicle | Placebo comparator | Ointment to be applied on the eyebrow twice daily. Receives: Other: Ointment vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to week 12 of investigator evaluated overall area score (ASoverall L+R) of eyebrow hair growth.
The percentage area of the identified left and right eyebrow area and left and right region of interest (ROI) covered by hair growth will be scored according to the following:
1-10 % - 1 11-20 % - 2 21-30 % - 3 31-40 % - 4 41-50 % - 5 51-60 % - 6 61-70 % - 7 71-80 % - 8 81-90 % - 9 91-100 % - 10
Measured: baseline to week 12
Secondary outcomes (3)
Treatment emergent AEs (including AEs relating to local tolerability)
Measured: baseline to week 12
Degree of response in change from baseline to Week 12 for ASoverall L+R
Complete response - ≥ 8 Partial response - 4-<8 Minimal response - 1-<4 No response - <1
Measured: baseline to Week 12
Investigator evaluation of cosmetic outcome at Week 12 as assessed by Cosmetic outcome Score
Is the appearance of the eyebrows cosmetically normal and acceptable? Yes - 1 No - due to insufficient regrowth area - 2 No - due to insufficient density - 3 No - due to uneven distribution - 4 No - due to other reason (explain, including combination of the above) - 5
Measured: baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2017
- Study start30 Oct 2017
- Primary completion16 May 2018
- Study completion16 May 2018
Why it stopped: Futility
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, LEO Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03325296
- Sponsor's protocol ID
- EXP-1377
- Other IDs
- 2017-002720-24, 2017
- Status last verified
- Jul 2018
- First submitted
- 25 Oct 2017
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- 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 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Twice Daily Application of LEO 124249 Ointment 30 mg/g for 12 Weeks on Eyebrow Alopecia Areata.
- ClinicalTrials.gov ID
- NCT03325296
- Acronym / sponsor ID
- EXP-1377
- Conditions
- Alopecia Areata
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Futility
- Enrolment
- 13 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2017 (actual)
- Primary completion
- 16 May 2018 (actual)
- Study completion
- 16 May 2018 (actual)
- First posted
- 30 Oct 2017 (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.
This clinical trial attempts to investigate the efficacy of LEO 124249 ointment in the treatment of alopecia areata on the eyebrows.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LEO 124249 ointment 30 mg/g | Experimental | Drug: LEO 124249Ointment to be applied on the eyebrow twice daily. |
| LEO 124249 ointment vehicle | Placebo comparator | Other: Ointment vehicleOintment to be applied on the eyebrow twice daily. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical unequivocal diagnosis of Alopecia Areata (patchy, univeralis and totalis), on both scalp and eyebrows as assessed by the investigator.
- Maximal disease duration of current episode of Alopecia Areata on the eyebrows of 3 years at screening.
- Maximal Alopecia Areata disease duration - defined as years of active disease - in other locations than eyebrows of 10 years at screening.
Key exclusion criteria (5 listed)
- Clinical diagnosis of diffuse type alopecia areata as assessed by the investigator.
- Any topical, intralesional therapy or procedure applied within 2 cm of the treatment area, within 4 weeks of randomisation, which in the opinion of the investigator, could interfere with the trial assessments. This includes, but is not limited to: corticosteroids, calcineurin inhibitors, calcipotriol, minoxidil, antimicrobials, prostaglandin analogs (e.g. bimatoprost), herbal extracts, topical immunotherapy with allergens or irritants and any laser or phototherapy, and eyebrow tattoo.
- Any systemic treatment with immunosuppressive drugs (e.g. methotrexate, cyclosporine, azathioprine), chloroquin derivatives, corticosteroids (including intralesional treatment outside the trial treatment area), or any other systemic therapy that in the opinion of the investigator could affect hair regrowth, within 4 weeks prior to randomisation.
- Any biologic medicinal product targeting the immune system within 5 half-lives and minimum 4 weeks prior to randomisation (e.g. anti-TNFα, anti-IL17, anti IL12/23, anti IL-4Rα targeting drugs).
- Systemic JAK inhibitor Ruxolitinib (Jakafi®/Jakavi®), Tofacitinib (Xeljanz®) at any time prior to randomisation.
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 124249Ointment containing LEO 124249 | Drug | LEO 124249 ointment 30 mg/g |
| Ointment vehicleOintment without active ingredients | Other | LEO 124249 ointment vehicle |
Primary outcome
Change from baseline to week 12 of investigator evaluated overall area score (ASoverall L+R) of eyebrow hair growth.
Time frame: baseline to week 12
The percentage area of the identified left and right eyebrow area and left and right region of interest (ROI) covered by hair growth will be scored according to the following: 1-10 % - 1 11-20 % - 2 21-30 % - 3 31-40 % - 4 41-50 % - 5 51-60 % - 6 61-70 % - 7 71-80 % - 8 81-90 % - 9 91-100 % - 10
3 secondary outcomes
Treatment emergent AEs (including AEs relating to local tolerability)
Time frame: baseline to week 12
Degree of response in change from baseline to Week 12 for ASoverall L+R
Time frame: baseline to Week 12
Investigator evaluation of cosmetic outcome at Week 12 as assessed by Cosmetic outcome Score
Time frame: baseline to Week 12
Results and safety
The study was stopped early (reason given: Futility). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- 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.
Study Director study director
LEO Pharma
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 Denmark.
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 3 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: stopped early, as of the sponsor's last update on 24 Feb 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 Denmark. 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?
The study was stopped early (reason given: Futility). Results are not available in the source record.
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 from baseline to week 12 of investigator evaluated overall area score (ASoverall L+R) of eyebrow hair growth. (time frame: baseline to week 12). 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 Feb 2025; AzTrials last refreshed its copy on 8 Nov 2026.