Trial · NCT03359356
Treatment of Alopecia Areata (AA) With Dupilumab in Patients With and Without Atopic Dermatitis (AD)
NCT03359356, Phase 2, Completed, Icahn School of Medicine at Mount Sinai; results first posted 2022-02-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Treatment of Alopecia Areata (AA) With Dupilumab in Patients With and Without Atopic Dermatitis (AD). Trials, record NCT03359356. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03359356
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treatment of Alopecia Areata (AA) With Dupilumab in Patients With and Without Atopic Dermatitis (AD)
- NCT number
- NCT03359356
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 60 participants, actual
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Conditions
- Alopecia Areata
- Interventions
- Dupilumab, Placebo
- First posted
- 2017-12-02
- Last updated
- 2022-09-13
- Results first posted
- 2022-02-14
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 24 | Baseline and 24 weeks | The SALT is a validated instrument for measuring the amount of scalp hair loss at a single point in time The SALT is a validated instrument for measuring the amount of scalp hair loss at a single point in time SALT - Scalp divided into four areas: vertex (40% of scalp surface area), right profile (18% of scalp surface area), left profile (18% of scalp surface area), and posterior scalp (24% of scalp surface area). Percentage of hair loss in these areas is multiplied by percent surface area of the scalp in that area. SALT score is the sum of percentage of hair loss in all areas. SALT scores range from 0 (no hair loss) to 100 (complete scalp hair loss) with lower score indicating better health outcomes/less hair loss. Primary Outcome is baseline minus Week 24 value. |
| Secondary | Change From Week 24 in the SALT Score at Week 48 | Week 24 and 48 weeks | SALT - Scalp divided into four areas: vertex (40% of scalp surface area), right profile (18% of scalp surface area), left profile (18% of scalp surface area), and posterior scalp (24% of scalp surface area). Percentage of hair loss in these areas is multiplied by percent surface area of the scalp in that area. SALT score is the sum of percentage of hair loss in all areas. Week 24 minus week 48 value. |
| Secondary | Change From Baseline in the SALT Score at Week 48 | Baseline and 48 weeks | Change in SALT score at Week 48 compared to Baseline. SALT - Scalp divided into four areas: vertex (40% of scalp surface area), right profile (18% of scalp surface area), left profile (18% of scalp surface area), and posterior scalp (24% of scalp surface area). Percentage of hair loss in these areas is multiplied by percent surface area of the scalp in that area. SALT score is the sum of percentage of hair loss in all areas. SALT scores range from 0 (no hair loss) to 100 (complete scalp hair loss) with lower score indicating better health outcomes/less hair loss. Baseline minus week 48 value. |
| Secondary | Number of Patients Achieving at Least 50% Improvement in Severity of Alopecia Tool (SALT) Score (SALT-50) at Weeks 24 and 48 Compared to Baseline | weeks 24 and 48 | Number of subjects achieving SALT-50 score at Weeks 24 and 48 compared to Baseline. SALT - Scalp divided into four areas: vertex (40% of scalp surface area), right profile (18% of scalp surface area), left profile (18% of scalp surface area), and posterior scalp (24% of scalp surface area). Percentage of hair loss in these areas is multiplied by percent surface area of the scalp in that area. SALT score is the sum of percentage of hair loss SALT scores range from 0 (no hair loss) to 100 (complete scalp hair loss) with lower score indicating better health outcomes/less hair loss.in all areas. |
| Secondary | Number of Patients Achieving at Least 75% Improvement in SALT-75 at Weeks 24 and 48 | Weeks 24 and 48 | Number of patients with Severity of Alopecia Tool (SALT) Score (SALT-75) (\> or equal to 75% improvement in SALT score) at Weeks 24 compared to Baseline. SALT - Scalp divided into four areas: vertex (40% of scalp surface area), right profile (18% of scalp surface area), left profile (18% of scalp surface area), and posterior scalp (24% of scalp surface area). Percentage of hair loss in these areas is multiplied by percent surface area of the scalp in that area. SALT score is the sum of percentage of hair loss in all areas. SALT scores range from 0 (no hair loss) to 100 (complete scalp hair loss) with lower score indicating better health outcomes/less hair loss. |
| Secondary | Number of Patients Achieving at Least 90% Improvement in Severity of Alopecia Tool (SALT) Score (SALT-90) at Weeks 24 and 48 | Weeks 24 and 48 | The number of patients achieving at least 90% improvement in Severity of Alopecia Tool (SALT) score (SALT-90) at Weeks 24, 48 compared to Baseline |
| Secondary | Change in Alopecia Areata Symptom Impact Scale (AASIS) | Weeks 24 and 48 | Change in AASIS at Weeks 24 and 48 compared to Baseline. AASIS is a 13-item instrument, each item scored from 0 to 10 where higher scores correspond to worse symptom impact, full range from 0 to 130. |
| Secondary | Change in Alopecia Areata Quality of Life Questionnaire | Weeks 24 and 48 | Change in the Alopecia Areata Quality of Life questionnaire (AA-QoL) at Weeks 24 and 48 compared to baseline. AAQoL is a 21-item instrument scored from 0 (poor) to 100 (good). |
| Secondary | Eyelash/Eyebrow Assessment Score Weeks 12, 24, 36, and 48 Compared to Baseline | Weeks 12, 24, 36, and 48 | Change in eyelash and eyebrow scores at Weeks 12, 24, 36, and 48 compared to baseline. The Eyelash/Eyebrow Assessment score based on a 5-point scale, ranging from 0 (none) to 4 (very prominent eyelashes/eyebrows). |
| Secondary | Change in EASI Scores From Baseline at Week 24 and 48 | Weeks 24 and 48 | Change from baseline in Eczema Area and Severity Index (EASI) at Weeks 24 and 48. EASI scores range from 0 (no symptoms) to 72 (severe eczema) with lower score indicating better health outcomes/less eczema. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 24 | Baseline and 24 weeks | score on a scale | MEAN | |
| SECONDARY | Change From Week 24 in the SALT Score at Week 48 | Week 24 and 48 weeks | score on a scale | MEAN | |
| SECONDARY | Change From Baseline in the SALT Score at Week 48 | Baseline and 48 weeks | score on a scale | MEAN | |
| SECONDARY | Number of Patients Achieving at Least 50% Improvement in Severity of Alopecia Tool (SALT) Score (SALT-50) at Weeks 24 and 48 Compared to Baseline | weeks 24 and 48 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Patients Achieving at Least 75% Improvement in SALT-75 at Weeks 24 and 48 | Weeks 24 and 48 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Patients Achieving at Least 90% Improvement in Severity of Alopecia Tool (SALT) Score (SALT-90) at Weeks 24 and 48 | Weeks 24 and 48 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Change in Alopecia Areata Symptom Impact Scale (AASIS) | Weeks 24 and 48 | score on a scale | MEAN | |
| SECONDARY | Change in Alopecia Areata Quality of Life Questionnaire | Weeks 24 and 48 | score on a scale | MEAN | |
| SECONDARY | Eyelash/Eyebrow Assessment Score Weeks 12, 24, 36, and 48 Compared to Baseline | Weeks 12, 24, 36, and 48 | One participant had missing eyelash data because of artificial eyelashes (glued on her real eyelashes). | score on a scale | MEAN |
| SECONDARY | Change in EASI Scores From Baseline at Week 24 and 48 | Weeks 24 and 48 | Data for only those participants with eczema. | score on a scale | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group48
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 24 | Placebo Then Dupilumab | -6.3 | Standard Deviation 4.2 | score on a scale | |
| Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 24 | Dupilumab | 2.3 | Standard Deviation 3 | score on a scale | |
| Change From Week 24 in the SALT Score at Week 48 | Placebo Then Dupilumab | -6.3 | Standard Error 4.2 | score on a scale | |
| Change From Week 24 in the SALT Score at Week 48 | Dupilumab | 2.3 | Standard Error 3 | score on a scale | |
| Change From Baseline in the SALT Score at Week 48 | Placebo Then Dupilumab | -6.3 | Standard Error 4.2 | score on a scale | |
| Change From Baseline in the SALT Score at Week 48 | Dupilumab | 2.3 | Standard Error 3 | score on a scale | |
| Number of Patients Achieving at Least 50% Improvement in Severity of Alopecia Tool (SALT) Score (SALT-50) at Weeks 24 and 48 Compared to Baseline | Placebo Then Dupilumab | Week 24 | 0 | Participants | |
| Number of Patients Achieving at Least 50% Improvement in Severity of Alopecia Tool (SALT) Score (SALT-50) at Weeks 24 and 48 Compared to Baseline | Dupilumab | Week 24 | 4 | Participants | |
| Number of Patients Achieving at Least 50% Improvement in Severity of Alopecia Tool (SALT) Score (SALT-50) at Weeks 24 and 48 Compared to Baseline | Placebo Then Dupilumab | Week 48 | 3 | Participants | |
| Number of Patients Achieving at Least 50% Improvement in Severity of Alopecia Tool (SALT) Score (SALT-50) at Weeks 24 and 48 Compared to Baseline | Dupilumab | Week 48 | 9 | Participants |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo Then Dupilumab | 20 | |
| Overall Study | STARTED | Dupilumab | 40 | |
| Overall Study | COMPLETED | Placebo Then Dupilumab | 20 | |
| Overall Study | COMPLETED | Dupilumab | 40 | |
| Overall Study | NOT COMPLETED | Placebo Then Dupilumab | 0 | |
| Overall Study | NOT COMPLETED | Dupilumab | 0 |
Source ClinicalTrials.gov
Adverse events28
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 | Injection site reaction | Skin and subcutaneous tissue disorders | Placebo | 0 | 20 | 0 |
| other | Injection site reaction | Skin and subcutaneous tissue disorders | Dupilumab | 2 | 40 | 2 |
| other | Eosinophilic dermatitis | Skin and subcutaneous tissue disorders | Placebo | 0 | 20 | 0 |
| other | Eosinophilic dermatitis | Skin and subcutaneous tissue disorders | Dupilumab | 1 | 40 | 1 |
| other | Fall | General disorders | Placebo | 1 | 20 | 1 |
| other | Fall | General disorders | Dupilumab | 0 | 40 | 0 |
| other | Fatigue | General disorders | Placebo | 0 | 20 | 0 |
| other | Fatigue | General disorders | Dupilumab | 1 | 40 | 1 |
| other | Gastrointestinal symptoms | Gastrointestinal disorders | Placebo | 1 | 20 | 1 |
| other | Gastrointestinal symptoms | Gastrointestinal disorders | Dupilumab | 3 | 40 | 3 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 20 |
| Total, all-cause mortality | Dupilumab | 0 | 40 |
| Total, other adverse events | Placebo | 4 | 20 |
| Total, other adverse events | Dupilumab | 22 | 40 |
| Total, serious adverse events | Placebo | 0 | 20 |
| Total, serious adverse events | Dupilumab | 1 | 40 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34460948 | DERIVED |
Source PubMed
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 |
|---|---|
| Dupilumab vs Placebo: deaths from any cause | Trial comparisons |
| Dupilumab 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/NCT03359356
GET https://conductscience.org/api/trials/v1/NCT03359356/results?page=2