Trial · NCT02684123
Pilot Study of the Safety and Efficacy of Apremilast in Subjects With Moderate to Severe Alopecia Areata
NCT02684123, Not applicable, Completed, Icahn School of Medicine at Mount Sinai; results first posted 2023-11-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pilot Study of the Safety and Efficacy of Apremilast in Subjects With Moderate to Severe Alopecia Areata. Trials, record NCT02684123. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02684123
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pilot Study of the Safety and Efficacy of Apremilast in Subjects With Moderate to Severe Alopecia Areata
- NCT number
- NCT02684123
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 30 participants, actual
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Conditions
- Alopecia Areata
- Interventions
- Apremilast, Placebo
- First posted
- 2016-02-17
- Last updated
- 2023-11-07
- Results first posted
- 2023-11-07
- Limitations and caveats
- This was an exploratory study. Future studies with a larger sample size are needed.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients With SALT50 | Baseline and Week 24 | Number of patients achieving 50% or greater improvement in their Severity of Alopecia Tool (SALT) score (SALT50) at Week 24 SALT50 is defined as the percent of patients achieving \>=50% reduction in SALT score compared to baseline. Scalp is divided into 4 areas namely, Vertex - 40% (0.4) of scalp surface area; right profile of scalp - 18% (0.18) of scalp surface area; left profile of scalp - 18% (0.18) of scalp surface area; Posterior aspect of scalp - 24% (0.24) of scalp surface area. Percentage of hair loss in any of these areas is percentage hair loss multiplied by percent surface area of the scalp in that area. SALT score is the sum of percentage of hair loss in all above mentioned areas. |
| Secondary | Mean Change in SALT Score | Baseline and week 4, 8, 12, 16, 20, 24 | Mean percent change in SALT score at 4, 8, 12, 16, 20, and 24 weeks as compared to baseline |
| Secondary | Phase 2: Number of Patients Achieving aaPGA Score of 3 or Above | Week 24 and Week 48 | Number of subjects achieving an alopecia areata Physician's Global Assessment (aaPGA) score of 3 or above at Weeks 24 (0, no regrowth; 1, \<25% of regrowth; 2, 25%-49% of regrowth; 3, 50%-74% of regrowth; 4, 75%-99% of re- growth; 5, 100% of regrowth). |
| Secondary | Phase 2: Change in AASIS | Week 24 and Weeks 48 | Change from Baseline in the Alopecia Areata Symptom Impact Scale (AASIS) at Weeks 24 and Week 48 The AASIS is a 13-items disease-specific patient-reported outcomes measure that asks participants about symptoms related to alopecia areata and how these symptoms interfere with daily functioning. Total scale ranges from 0-130, with higher score indicating more symptoms. |
| Secondary | Phase 2: AA-QoL | Baseline, Week 24 and Weeks 48 | Change from baseline in the Alopecia Areata Quality of Life questionnaire (AA-QoL) at Weeks 24 and Weeks 48. Total scale from 0 to 100, with higher score indicating better quality of life. |
| Secondary | Phase 2: Semiquantitative Score | Baseline, Week 24 and Weeks 48 | Semiquantitative score using SALT subclasses (0, no hair loss; 1, \<25% hair loss; 2, 25%-49% hair loss; 3, 50%-74% hair loss; 4, 75%-99% hair loss; 5, 100% hair loss) at week 24 and week 48 compared to baseline |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients With SALT50 | Baseline and Week 24 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Mean Change in SALT Score | Baseline and week 4, 8, 12, 16, 20, 24 | Data for participants who returned for particular visits. | Mean percent change | MEAN |
| SECONDARY | Phase 2: Number of Patients Achieving aaPGA Score of 3 or Above | Week 24 and Week 48 | Only those who completed treatments as respective week analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Phase 2: Change in AASIS | Week 24 and Weeks 48 | Data for participants who returned for particular visits | score on a scale | MEAN |
| SECONDARY | Phase 2: AA-QoL | Baseline, Week 24 and Weeks 48 | Data for participants who returned for particular visits | score on a scale | MEAN |
| SECONDARY | Phase 2: Semiquantitative Score | Baseline, Week 24 and Weeks 48 | Data for participants who returned for particular visits | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group33
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients With SALT50 | Apremilast | 1 | Participants | ||
| Number of Patients With SALT50 | Placebo | 1 | Participants | ||
| Mean Change in SALT Score | Apremilast | Week 4 | -0.13 | Standard Error 0.56 | Mean percent change |
| Mean Change in SALT Score | Placebo | Week 4 | -0.11 | Standard Error 0.11 | Mean percent change |
| Mean Change in SALT Score | Apremilast | Week 8 | -2.39 | Standard Error 2.58 | Mean percent change |
| Mean Change in SALT Score | Placebo | Week 8 | -2.86 | Standard Error 1.47 | Mean percent change |
| Mean Change in SALT Score | Apremilast | Week 12 | -0.99 | Standard Error 1.52 | Mean percent change |
| Mean Change in SALT Score | Placebo | Week 12 | -4.07 | Standard Error 2.21 | Mean percent change |
| Mean Change in SALT Score | Apremilast | Week 16 | -8.15 | Standard Error 7.37 | Mean percent change |
| Mean Change in SALT Score | Placebo | Week 16 | -10.55 | Standard Error 6.68 | Mean percent change |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Phase 1 | STARTED | Apremilast | 20 | |
| Phase 1 | STARTED | Placebo | 10 | |
| Phase 1 | COMPLETED | Apremilast | 12 | |
| Phase 1 | COMPLETED | Placebo | 9 | |
| Phase 1 | NOT COMPLETED | Apremilast | 8 | |
| Phase 1 | NOT COMPLETED | Placebo | 1 | |
| Eligibility Determination for Phase 2 | STARTED | Apremilast | 12 | |
| Eligibility Determination for Phase 2 | STARTED | Placebo | 9 | |
| Eligibility Determination for Phase 2 | COMPLETED | Apremilast | 1 | |
| Eligibility Determination for Phase 2 | COMPLETED | Placebo | 9 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events20
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 | Nausea | Gastrointestinal disorders | Apremilast | 4 | 20 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 3 | 10 | |
| other | Diarrhea | Gastrointestinal disorders | Apremilast | 3 | 20 | |
| other | Diarrhea | Gastrointestinal disorders | Placebo | 1 | 10 | |
| other | Upper respiratory tract infections | Infections and infestations | Apremilast | 1 | 20 | |
| other | Upper respiratory tract infections | Infections and infestations | Placebo | 1 | 10 | |
| other | Fatigue | General disorders | Apremilast | 0 | 20 | |
| other | Fatigue | General disorders | Placebo | 1 | 10 | |
| other | Tinea pedis | Skin and subcutaneous tissue disorders | Apremilast | 1 | 20 | |
| other | Tinea pedis | Skin and subcutaneous tissue disorders | Placebo | 0 | 10 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Apremilast | 0 | 20 |
| Total, all-cause mortality | Placebo | 0 | 10 |
| Total, other adverse events | Apremilast | 9 | 20 |
| Total, other adverse events | Placebo | 5 | 10 |
| Total, serious adverse events | Apremilast | 0 | 20 |
| Total, serious adverse events | Placebo | 0 | 10 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Apremilast vs Placebo: Number of Patients With SALT50 | Trial comparisons |
| Apremilast vs Placebo: deaths from any cause | Trial comparisons |
| Apremilast vs Placebo: 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/NCT02684123
GET https://conductscience.org/api/trials/v1/NCT02684123/results?page=2