Trial · NCT02561585
LEO 124249 Ointment in the Treatment of Alopecia Areata
NCT02561585, Phase 2, Completed, LEO Pharma; results first posted 2019-04-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. LEO 124249 Ointment in the Treatment of Alopecia Areata. Trials, record NCT02561585. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02561585
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- LEO 124249 Ointment in the Treatment of Alopecia Areata
- NCT number
- NCT02561585
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 40 participants, actual
- Lead sponsor
- LEO Pharma
- Conditions
- Alopecia Areata
- Interventions
- LEO 124249, Vehicle
- First posted
- 2015-09-28
- Last updated
- 2025-03-06
- Results first posted
- 2019-04-16
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Severity of Alopecia Areata Tool (SALT) Score | 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. |
| Secondary | Summary of Absolute SALT Score | At baseline (Day 1), Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84) | 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. |
| Secondary | Summary of Change in SALT Score | From baseline (Day 1) to Week 4 (Day 28), Week 8 (Day 56), and Week 12 (Day 84) | 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. |
| Secondary | Summary of Relative Change in SALT Score | From baseline (Day 1) to Week 4 (Day 28), Week 8 (Day 56), and Week 12 (Day 84) | 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. |
| Secondary | Percentage of Patients Who Achieve 50% Improvement in the SALT Score | At Week 12 (Day 84) | The event of having at least 50% reduction in SALT score at Week 12 (Day 84) as compared to baseline (Day 1) |
| Secondary | Hair Length | At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84) | Hair length measured in millimeters. |
| Secondary | Hair Growth Rate | At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84) | Change in hair length measured in millimeters per day. |
| Secondary | Relative Hair Thickness | At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84) | Thickness relative to participant's normal scalp hair. Relative assessment not applicable for participants with alopecia areata totalis and universalis. |
| Secondary | Hair Type | At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84) | Hair type being either vellus hair or terminal hair. Hair type is not applicable for participants with alopecia areata totalis and universalis. |
| Secondary | Hair Color | At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84) | Absolute color of hair. Hair color is not applicable for alopecia areata totalis and universalis. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Severity of Alopecia Areata Tool (SALT) Score | From baseline (Day 1) to Week 12 (Day 84) | The full analysis set (FAS) was defined as all randomized participants who received at least one application of LEO 124249 (20) ointment or LEO 124249 vehicle (11) and had at least one post-baseline efficacy assessment. Only the participants completing Week 12 have been included in the calculation of the change from baseline in the SALT score. | units on a scale | MEAN |
| SECONDARY | Summary of Absolute SALT Score | At baseline (Day 1), Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84) | The full analysis set (FAS) was defined as all randomized participants who received at least one application of LEO 124249 (20) ointment or LEO 124249 vehicle (11) and had at least one post-baseline efficacy assessment. Only the participants who attended the individual visits where included in the analysis. | units on a scale | MEAN |
| SECONDARY | Summary of Change in SALT Score | From baseline (Day 1) to Week 4 (Day 28), Week 8 (Day 56), and Week 12 (Day 84) | The full analysis set (FAS) was defined as all randomized participants who received at least one application of LEO 124249 (20) ointment or LEO 124249 vehicle (11) and had at least one post-baseline efficacy assessment. Only the participants who attended the individual visits where included in the analysis. | units on a scale | MEAN |
| SECONDARY | Summary of Relative Change in SALT Score | From baseline (Day 1) to Week 4 (Day 28), Week 8 (Day 56), and Week 12 (Day 84) | The full analysis set (FAS) was defined as all randomized participants who received at least one application of LEO 124249 (20) ointment or LEO 124249 vehicle (11) and had at least one post-baseline efficacy assessment. Only the participants who attended the individual visits where included in the analysis. | percentage change | MEAN |
| SECONDARY | Percentage of Patients Who Achieve 50% Improvement in the SALT Score | At Week 12 (Day 84) | The full analysis set (FAS) was defined as all randomized participants who received at least one application of LEO 124249 (20) ointment or LEO 124249 vehicle (11). Only the participants completing Week 12 have been included in the analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Hair Length | At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84) | The full analysis set (FAS) was defined as all randomized participants who received at least one application of LEO 124249 (20) ointment or LEO 124249 vehicle (11) and had at least one post-baseline efficacy assessment. Only the participants who attended the individual visits where included in the analysis. | mm | MEAN |
| SECONDARY | Hair Growth Rate | At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84) | The full analysis set (FAS) was defined as all randomized participants who received at least one application of LEO 124249 (20) ointment or LEO 124249 vehicle (11) and had at least one post-baseline efficacy assessment. Only the participants who attended the individual visits where included in the analysis. | mm/day | MEAN |
| SECONDARY | Relative Hair Thickness | At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84) | The full analysis set (FAS) was defined as all randomized participants who received at least one application of LEO 124249 (20) ointment or LEO 124249 vehicle (11) and had at least one post-baseline efficacy assessment. Only the participants who attended the individual visits where included in the analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Hair Type | At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84) | The full analysis set (FAS) was defined as all randomized participants who received at least one application of LEO 124249 (20) ointment or LEO 124249 vehicle (11) and had at least one post-baseline efficacy assessment. Only the participants who attended the individual visits where included in the analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Hair Color | At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84) | The full analysis set (FAS) was defined as all randomized participants who received at least one application of LEO 124249 (20) ointment or LEO 124249 vehicle (11) and had at least one post-baseline efficacy assessment. Only the participants who attended the individual visits where included in the analysis. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group206
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Severity of Alopecia Areata Tool (SALT) Score | LEO 124249 | -3.8 | Standard Deviation 9.3 | units on a scale | |
| Change in Severity of Alopecia Areata Tool (SALT) Score | LEO 124249 Vehicle | -3.4 | Standard Deviation 17.0 | units on a scale | |
| Summary of Absolute SALT Score | LEO 124249 | Baseline (Day 1) | 67.2 | Standard Deviation 25.1 | units on a scale |
| Summary of Absolute SALT Score | LEO 124249 Vehicle | Baseline (Day 1) | 74.4 | Standard Deviation 24.3 | units on a scale |
| Summary of Absolute SALT Score | LEO 124249 | Week 4 (Day 28) | 63.1 | Standard Deviation 26.7 | units on a scale |
| Summary of Absolute SALT Score | LEO 124249 Vehicle | Week 4 (Day 28) | 71.0 | Standard Deviation 25.9 | units on a scale |
| Summary of Absolute SALT Score | LEO 124249 | Week 8 (Day 56) | 62.7 | Standard Deviation 27.5 | units on a scale |
| Summary of Absolute SALT Score | LEO 124249 Vehicle | Week 8 (Day 56) | 68.6 | Standard Deviation 31.2 | units on a scale |
| Summary of Absolute SALT Score | LEO 124249 | Week 12 (Day 84) | 61.2 | Standard Deviation 28.9 | units on a scale |
| Summary of Absolute SALT Score | LEO 124249 Vehicle | Week 12 (Day 84) | 66.4 | Standard Deviation 38.0 | units on a scale |
1 to 10 of 206Source ClinicalTrials.gov
See all 206 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | LEO 124249 | 20 | |
| Overall Study | STARTED | LEO 124249 Vehicle | 11 | |
| Overall Study | COMPLETED | LEO 124249 | 17 | |
| Overall Study | COMPLETED | LEO 124249 Vehicle | 6 | |
| Overall Study | NOT COMPLETED | LEO 124249 | 3 | |
| Overall Study | NOT COMPLETED | LEO 124249 Vehicle | 5 |
Source ClinicalTrials.gov
Adverse events12
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Folliculitis | Infections and infestations | LEO 124249 | 2 | 20 | 2 |
| other | Folliculitis | Infections and infestations | LEO 124249 Vehicle | 0 | 11 | 0 |
| other | Conjunctivitis | Infections and infestations | LEO 124249 | 1 | 20 | 1 |
| other | Conjunctivitis | Infections and infestations | LEO 124249 Vehicle | 0 | 11 | 0 |
| other | Upper respiratory tract infection | Infections and infestations | LEO 124249 | 0 | 20 | 0 |
| other | Upper respiratory tract infection | Infections and infestations | LEO 124249 Vehicle | 1 | 11 | 1 |
| other | Alopecia | Skin and subcutaneous tissue disorders | LEO 124249 | 1 | 20 | 1 |
| other | Alopecia | Skin and subcutaneous tissue disorders | LEO 124249 Vehicle | 1 | 11 | 1 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | LEO 124249 | 1 | 20 | 1 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | LEO 124249 Vehicle | 0 | 11 | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | LEO 124249 | 0 | 20 |
| Total, all-cause mortality | LEO 124249 Vehicle | 0 | 11 |
| Total, other adverse events | LEO 124249 | 5 | 20 |
| Total, other adverse events | LEO 124249 Vehicle | 2 | 11 |
| Total, serious adverse events | LEO 124249 | 0 | 20 |
| Total, serious adverse events | LEO 124249 Vehicle | 0 | 11 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| LEO 124249 vs LEO 124249 Vehicle: deaths from any cause | Trial comparisons |
| LEO 124249 vs LEO 124249 Vehicle: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02561585
GET https://conductscience.org/api/trials/v1/NCT02561585/results?page=2