Phase 2
N=31
LEO 124249 Ointment in the Treatment of Alopecia Areata
Alopecia Areata
Bottom Line
View on ClinicalTrials.gov: NCT02561585 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcome: Primary: Change in Severity of Alopecia Areata Tool (SALT) Score — -3.8; -3.4 units on a scale — p=0.97
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- LEO 124249 (Drug); Vehicle (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- LEO Pharma
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Severity of Alopecia Areata Tool (SALT) Score |
-3.8; -3.4 | 0.97 |
| SECONDARY Summary of Absolute SALT Score |
67.2; 74.4; 63.1; 71.0; 62.7; 68.6 | — |
| SECONDARY Summary of Change in SALT Score |
-2.2; 0.0; -2.5; -1.5; -3.8; -3.4 | — |
| SECONDARY Summary of Relative Change in SALT Score |
-4.6; -0.3; -5.6; -5.3; -7.7; -9.1 | — |
| SECONDARY Percentage of Patients Who Achieve 50% Improvement in the SALT Score |
2; 1; 15; 5 | — |
| SECONDARY Hair Length |
12.7; 5.6; 18.2; 10.3; 25.1; 16.3 | — |
| SECONDARY Hair Growth Rate |
0.4; 0.1; 0.2; 0.1; 0.3; 0.1 | — |
| SECONDARY Relative Hair Thickness |
10; 1; 1; 0; 0; 0 | — |
| SECONDARY Hair Type |
4; 1; 9; 2; 4; 2 | — |
| SECONDARY Hair Color |
4; 1; 2; 1; 3; 0 | — |
| SECONDARY Global Assessment of Overall Hair Regrowth Compared to Baseline |
0; 0; 1; 0; 1; 1 | — |
| SECONDARY Participant's Global Assessment of Hair Regrowth |
8; 6; 8; 3; 2; 0 | — |
| SECONDARY Subcategory and Total Score of the Alopecia Areata Quality of Life Questionnaire (AA-QLI) |
25.9; 24.3; 25.5; 23.7; 18.7; 17.5 | — |
| SECONDARY Treatment Satisfaction Questionnaire for Medication Score |
28.9; 41.7; 94.5; 100.0; 52.3; 54.6 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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).
Data sourced from ClinicalTrials.gov (NCT02561585). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.