Phase 2
Completed N=31
LEO 124249 Ointment in the Treatment of Alopecia Areata
Source: ClinicalTrials.gov NCT02561585 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcomePrimary: Change in Severity of Alopecia Areata Tool (SALT) Score — -3.8; -3.4 units on a scale — p=0.97
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.
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 | — |
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. Informational only — not medical advice.