Trial · NCT00931242
Study of Apremilast in Atopic or Contact Dermatitis
NCT00931242, Phase 2, Completed, Tufts Medical Center; results first posted 2010-12-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Apremilast in Atopic or Contact Dermatitis. Trials, record NCT00931242. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00931242
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Apremilast in Atopic or Contact Dermatitis
- NCT number
- NCT00931242
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 10 participants, actual
- Lead sponsor
- Tufts Medical Center
- Conditions
- Atopic Dermatitis, Allergic Contact Dermatitis
- Interventions
- Apremilast
- First posted
- 2009-07-02
- Last updated
- 2010-12-20
- Results first posted
- 2010-12-20
- Limitations and caveats
- This was a small, single-arm open-label study with no placebo or comparison group to serve as a control.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients Achieving an Improvement (Decrease) in IGA (Investigator Global Assessment) by Two or More Points | 12 weeks | Improvement in IGA (Investigator Global Assessment) by two or more points on a five point scale, with 0 being no disease activity and 5 being maximum disease activity, at week 12 |
| Secondary | Number of Patients Achieving 75% Reduction in Eczema Area and Severity Index (EASI) Score at Week 12 in Reference to Week 0 | 12 weeks | EASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, edema, lichenification, and excoriations/erosions are scored on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 to 6. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score. |
| Secondary | Number of Patients Achieving 50% Reduction in Eczema Area and Severity Index (EASI) Score at Week 12 in Reference to Week 0 | 12 weeks | EASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, edema, lichenification, and excoriations/erosions are scored on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 to 6. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients Achieving an Improvement (Decrease) in IGA (Investigator Global Assessment) by Two or More Points | 12 weeks | participants | NUMBER | |
| SECONDARY | Number of Patients Achieving 75% Reduction in Eczema Area and Severity Index (EASI) Score at Week 12 in Reference to Week 0 | 12 weeks | participants | NUMBER | |
| SECONDARY | Number of Patients Achieving 50% Reduction in Eczema Area and Severity Index (EASI) Score at Week 12 in Reference to Week 0 | 12 weeks | participants | NUMBER |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients Achieving an Improvement (Decrease) in IGA (Investigator Global Assessment) by Two or More Points | Apremilast | 2 | participants | ||
| Number of Patients Achieving 75% Reduction in Eczema Area and Severity Index (EASI) Score at Week 12 in Reference to Week 0 | Apremilast | 1 | participants | ||
| Number of Patients Achieving 50% Reduction in Eczema Area and Severity Index (EASI) Score at Week 12 in Reference to Week 0 | Apremilast | 2 | participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Apremilast | 10 | |
| Overall Study | STARTED | Screen Failures | 2 | |
| Overall Study | COMPLETED | Apremilast | 5 | |
| Overall Study | COMPLETED | Screen Failures | 0 | |
| Overall Study | NOT COMPLETED | Apremilast | 5 | |
| Overall Study | NOT COMPLETED | Screen Failures | 2 |
Source ClinicalTrials.gov
Adverse events30
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 | Conjunctivitis | Eye disorders | Apremilast | 1 | 12 | 1 |
| other | Headache | Nervous system disorders | Apremilast | 2 | 12 | 2 |
| other | Burn | Skin and subcutaneous tissue disorders | Apremilast | 1 | 12 | 1 |
| other | Nausea | Gastrointestinal disorders | Apremilast | 2 | 12 | 2 |
| other | asymptomatic sinus arrythmia per EKG | Cardiac disorders | Apremilast | 1 | 12 | 1 |
| other | GI upset | Gastrointestinal disorders | Apremilast | 1 | 12 | 1 |
| other | soft stool | Gastrointestinal disorders | Apremilast | 1 | 12 | 1 |
| other | dermatitis flare | Skin and subcutaneous tissue disorders | Apremilast | 4 | 12 | 4 |
| other | foot fracture after mechanical fall | Musculoskeletal and connective tissue disorders | Apremilast | 1 | 12 | 1 |
| other | rigors | Nervous system disorders | Apremilast | 1 | 12 | 1 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Apremilast | ||
| Total, other adverse events | Apremilast | 9 | 12 |
| Total, serious adverse events | Apremilast | 1 | 12 |
Source ClinicalTrials.gov
Papers10
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00931242
GET https://conductscience.org/api/trials/v1/NCT00931242/events?page=2