Trial · NCT00708916
Safety Study of Clinical and Immune Effects of Phosphodiesterase 4 (PDE-4) Inhibitor in Cutaneous Lupus Patients
NCT00708916, Phase 1, Phase 2, Completed, NYU Langone Health; results first posted 2021-03-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety Study of Clinical and Immune Effects of Phosphodiesterase 4 (PDE-4) Inhibitor in Cutaneous Lupus Patients. Trials, record NCT00708916. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00708916
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety Study of Clinical and Immune Effects of Phosphodiesterase 4 (PDE-4) Inhibitor in Cutaneous Lupus Patients
- NCT number
- NCT00708916
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 8 participants, actual
- Lead sponsor
- NYU Langone Health
- Conditions
- Discoid Lupus Erythematosus
- Interventions
- CC-10004
- First posted
- 2008-07-03
- Last updated
- 2021-03-03
- Results first posted
- 2021-03-03
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cutaneous LE Diseases Area and Severity Index (CLASI) Score Based on Extent of Symptoms | 16 Weeks | To evaluate the clinical response of cutaneous lupus patients to CC-10004. From J Invest Dermatol. 2005 Nov; 125(5): 889-894.doi: 10.1111/j.0022-202X.2005.23889.x: The CLASI consists of two scores. One summarizes the activity of the disease on a scale from 0 to 30, higher score translates to more severe disease. The second is a measure of the damage done by the disease on a scale form 0 to 30, higher score translates to more severe disease. Activity is scored on the basis of erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and non-scarring alopecia. Damage is scored in terms of dyspigmentation and scarring, including scarring alopecia. Each score is reported separately. Outcome measures are reported for each time point for each subject due to the low numbers of enrollment. |
| Secondary | Dermatology Quality of Life Index (DQLI) | 16 Weeks | 1. To evaluate the clinical safety of CC-10004 in cutaneous lupus patients 2. To determine the effect of CC-10004 on immune parameters in the skin 3. To determine the effect of CC-10004 on immune parameters in the blood 1. in vivo 2. in vitro 4. To determine the effect of CC-10004 on QOL and psychological outcome measures |
| Secondary | Common Terminology Criteria for Adverse Events v3.0 (CTCAE) | Weeks 1, 2, 4, 6, 8, 10, 12, 16 | 1. To evaluate the clinical safety of CC-10004 in cutaneous lupus patients 2. To determine the effect of CC-10004 on immune parameters in the skin 3. To determine the effect of CC-10004 on immune parameters in the blood 1. in vivo 2. in vitro 4. To determine the effect of CC-10004 on QOL and psychological outcome measures |
| Secondary | Dermal and Circulating Blood Plasmacytoid Dendritic Cell Levels | Weeks 0, 4 (dermal and circulating); week 12 (circulating only) | |
| Secondary | Dermal and Circulating Blood T Regulatory Cell Levels | Weeks 0, 4 (dermal and blood); Week 12 (blood only) | 1. To evaluate the clinical safety of CC-10004 in cutaneous lupus patients 2. To determine the effect of CC-10004 on immune parameters in the skin 3. To determine the effect of CC-10004 on immune parameters in the blood 1. in vivo 2. in vitro 4. To determine the effect of CC-10004 on QOL and psychological outcome measures |
| Secondary | Plasma Cytokine Levels | Weeks 0, 4, 12 | 1. To evaluate the clinical safety of CC-10004 in cutaneous lupus patients 2. To determine the effect of CC-10004 on immune parameters in the skin 3. To determine the effect of CC-10004 on immune parameters in the blood 1. in vivo 2. in vitro 4. To determine the effect of CC-10004 on QOL and psychological outcome measures |
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 | Cutaneous LE Diseases Area and Severity Index (CLASI) Score Based on Extent of Symptoms | 16 Weeks | The PI and study team has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful. No study data for primary outcome measure are available | ||
| SECONDARY | Dermatology Quality of Life Index (DQLI) | 16 Weeks | Secondary outcome measures were not measured in this study. | ||
| SECONDARY | Common Terminology Criteria for Adverse Events v3.0 (CTCAE) | Weeks 1, 2, 4, 6, 8, 10, 12, 16 | PI no longer with institution. No secondary outcome measure data available for reporting. | ||
| SECONDARY | Dermal and Circulating Blood Plasmacytoid Dendritic Cell Levels | Weeks 0, 4 (dermal and circulating); week 12 (circulating only) | PI no longer with institution. No secondary outcome measure data available for reporting. | ||
| SECONDARY | Dermal and Circulating Blood T Regulatory Cell Levels | Weeks 0, 4 (dermal and blood); Week 12 (blood only) | PI no longer with institution. No secondary outcome measure data available for reporting. | ||
| SECONDARY | Plasma Cytokine Levels | Weeks 0, 4, 12 | PI no longer with institution. No secondary outcome measure data available for reporting. |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Apremilast | 12 | |
| Overall Study | COMPLETED | Apremilast | 8 | |
| Overall Study | NOT COMPLETED | Apremilast | 4 |
Source ClinicalTrials.gov
Adverse events5
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 | 8 | 4 |
| other | Headache | Nervous system disorders | Apremilast | 2 | 8 | 2 |
| other | Diarrhea | Gastrointestinal disorders | Apremilast | 1 | 8 | 1 |
| serious | Lichenoid Dermatitis | Skin and subcutaneous tissue disorders | Apremilast | 1 | 8 | 1 |
| serious | Neuraopathy Sensory | Nervous system disorders | Apremilast | 1 | 8 | 1 |
Source ClinicalTrials.gov
Adverse 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 | 4 | 8 |
| Total, serious adverse events | Apremilast | 2 | 8 |
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 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/NCT00708916
GET https://conductscience.org/api/trials/v1/NCT00708916/registered