Trial · NCT00892281
ORCA - Oracea® for Rosacea: A Community-based Assessment
NCT00892281, Phase 4, Completed, Galderma R&D; results first posted 2010-11-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. ORCA - Oracea® for Rosacea: A Community-based Assessment. Trials, record NCT00892281. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00892281
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- ORCA - Oracea® for Rosacea: A Community-based Assessment
- NCT number
- NCT00892281
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 1,421 participants, actual
- Lead sponsor
- Galderma R&D
- Conditions
- Rosacea
- Interventions
- doxycycline (Oracea®) 40 mg modified release as monotherapy, doxycycline (Oracea®) 40 mg modified release as add-on therapy
- First posted
- 2009-05-04
- Last updated
- 2022-08-25
- Results first posted
- 2010-11-18
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Investigator's Global Assessment (IGA) Score From Baseline to Endpoint | Baseline to Week 12 | Number of participants with a change (Week 12 minus Baseline) in Investigator's Global Assessment (IGA) score. IGA is measured on a scale from 0 - 4 with 0 = Clear; 1 = Near Clear; 2 = Mild; 3 = Moderate; and 4 = Severe. Results values (+4, +3, +2, +1, 0, -1, -2, -3, -4) represent change from Baseline to Week 12. |
| Secondary | Change in Clinician's Erythema Assessment Scale (CEA) Score From Baseline to Endpoint | Baaseline to Week 12 | Number of participants with a change (Week 12 minus Baseline) in Clinician's Erythema Assessment Scale (CEA) score. Clinician's Erythema Assessment Scale (CEA) is a scale from 0 - 4 with 0 = None; 1 = Mild; 2 = Moderate; 3 = Significant; and 4 = Severe. Results values (+4, +3, +2, +1, 0, -1, -2, -3, -4) represent change from Baseline to Week 12 in CEA. |
| Secondary | Number of Treatment Responders at Endpoint, Where Response is Defined as an IGA Score of 0 (Clear) or 1 (Near Clear) | Baseline to Week 12 | Number of treatment responders at week 12, where response is defined as an Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (near clear). IGA is measured on a scale from 0 - 4 with 0 = Clear, 1 = Near Clear; 2 = Mild; 3 = Moderate; and 4 = Severe with 0 being best and 4 being worst. |
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 | Change in Investigator's Global Assessment (IGA) Score From Baseline to Endpoint | Baseline to Week 12 | Per protocol | participants | NUMBER |
| SECONDARY | Change in Clinician's Erythema Assessment Scale (CEA) Score From Baseline to Endpoint | Baaseline to Week 12 | participants | NUMBER | |
| SECONDARY | Number of Treatment Responders at Endpoint, Where Response is Defined as an IGA Score of 0 (Clear) or 1 (Near Clear) | Baseline to Week 12 | participants | NUMBER |
Source ClinicalTrials.gov
Results by group38
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Investigator's Global Assessment (IGA) Score From Baseline to Endpoint | Oracea® as Monotherapy | +4 (worsening of rosacea by 4 IGA scale levels | 0 | participants | |
| Change in Investigator's Global Assessment (IGA) Score From Baseline to Endpoint | Oracea® as add-on Therapy | +4 (worsening of rosacea by 4 IGA scale levels | 0 | participants | |
| Change in Investigator's Global Assessment (IGA) Score From Baseline to Endpoint | Oracea® as Monotherapy | +3 (worsening of rosacea by 3 IGA scale levels) | 0 | participants | |
| Change in Investigator's Global Assessment (IGA) Score From Baseline to Endpoint | Oracea® as add-on Therapy | +3 (worsening of rosacea by 3 IGA scale levels) | 0 | participants | |
| Change in Investigator's Global Assessment (IGA) Score From Baseline to Endpoint | Oracea® as Monotherapy | +2 (worsening of rosacea by 2 IGA scale levels) | 0 | participants | |
| Change in Investigator's Global Assessment (IGA) Score From Baseline to Endpoint | Oracea® as add-on Therapy | +2 (worsening of rosacea by 2 IGA scale levels) | 0 | participants | |
| Change in Investigator's Global Assessment (IGA) Score From Baseline to Endpoint | Oracea® as Monotherapy | +1 (worsening of rosacea by 1 IGA scale level) | 4 | participants | |
| Change in Investigator's Global Assessment (IGA) Score From Baseline to Endpoint | Oracea® as add-on Therapy | +1 (worsening of rosacea by 1 IGA scale level) | 4 | participants | |
| Change in Investigator's Global Assessment (IGA) Score From Baseline to Endpoint | Oracea® as Monotherapy | 0 (no change in IGA scale level) | 70 | participants | |
| Change in Investigator's Global Assessment (IGA) Score From Baseline to Endpoint | Oracea® as add-on Therapy | 0 (no change in IGA scale level) | 11 | participants |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Oracea® as Monotherapy | 1,197 | |
| Overall Study | STARTED | Oracea® as add-on Therapy | 224 | |
| Overall Study | COMPLETED | Oracea® as Monotherapy | 930 | |
| Overall Study | COMPLETED | Oracea® as add-on Therapy | 187 | |
| Overall Study | NOT COMPLETED | Oracea® as Monotherapy | 267 | |
| Overall Study | NOT COMPLETED | Oracea® as add-on Therapy | 37 |
Source ClinicalTrials.gov
Adverse events10
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 |
|---|---|---|---|---|---|---|
| serious | Angina pectoris | Cardiac disorders | Oracea® as Monotherapy | 1 | 1,196 | 1 |
| serious | Angina pectoris | Cardiac disorders | Oracea® as add-on Therapy | 0 | 224 | 0 |
| serious | Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Oracea® as Monotherapy | 1 | 1,196 | 1 |
| serious | Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Oracea® as add-on Therapy | 0 | 224 | 0 |
| serious | Cardiac disorder | Cardiac disorders | Oracea® as Monotherapy | 1 | 1,196 | 1 |
| serious | Cardiac disorder | Cardiac disorders | Oracea® as add-on Therapy | 0 | 224 | 0 |
| serious | Cerebrovascular accident | Nervous system disorders | Oracea® as Monotherapy | 1 | 1,196 | 1 |
| serious | Cerebrovascular accident | Nervous system disorders | Oracea® as add-on Therapy | 0 | 224 | 0 |
| serious | Thrombophlebitis superficial | Vascular disorders | Oracea® as Monotherapy | 1 | 1,196 | 1 |
| serious | Thrombophlebitis superficial | Vascular disorders | Oracea® as add-on Therapy | 0 | 224 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Oracea® as Monotherapy | ||
| Total, all-cause mortality | Oracea® as add-on Therapy | ||
| Total, other adverse events | Oracea® as Monotherapy | 0 | 1,196 |
| Total, other adverse events | Oracea® as add-on Therapy | 0 | 224 |
| Total, serious adverse events | Oracea® as Monotherapy | 5 | 1,196 |
| Total, serious adverse events | Oracea® as add-on Therapy | 0 | 224 |
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 |
|---|---|
| Oracea® as Monotherapy vs Oracea® as add-on Therapy: Number of Treatment Responders at Endpoint, Where Response is Defined as an IGA Score of 0 (Clear) or 1 (Near Clear) | Trial comparisons |
| Oracea® as Monotherapy vs Oracea® as add-on Therapy: 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/NCT00892281
GET https://conductscience.org/api/trials/v1/NCT00892281/results?page=2