Trial · NCT01659853
Efficacy and Safety Study Comparing CD07805/47 Gel 0.5% to Azelaic Acid Gel 15% in Subjects With Erythema of Rosacea
NCT01659853, Phase 3, Completed, Galderma R&D; results first posted 2014-07-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety Study Comparing CD07805/47 Gel 0.5% to Azelaic Acid Gel 15% in Subjects With Erythema of Rosacea. Trials, record NCT01659853. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01659853
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Study Comparing CD07805/47 Gel 0.5% to Azelaic Acid Gel 15% in Subjects With Erythema of Rosacea
- NCT number
- NCT01659853
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 70 participants, actual
- Lead sponsor
- Galderma R&D
- Conditions
- Erythema, Rosacea
- Interventions
- CD07805/47 gel 0.5%/CD07805/47 Vehicle, azelaic acid gel 15%
- First posted
- 2012-08-08
- Last updated
- 2022-08-25
- Results first posted
- 2014-07-10
- Limitations and caveats
A significant period effect was observed for CEA indicating there was carryover from period 1 to period 2. Therefore, as stated a priori in the protocol, only data from period 1 were used to analyze efficacy. All safety data are reported.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Composite Success | Hour 6 on Day 15 | Composite Success, defined as a 2-grade improvement at 6 hours on both the clinician's and subject's erythema assessments at the end of each treatment period |
| Secondary | Onset of Action | 30 minutes after baseline treatment application on Day 15 | Onset of action, defined as an improvement on both the clinician's and subject's erythema assessments at 30 minutes post baseline application |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Composite Success | Hour 6 on Day 15 | A carryover effect was observed from Period 1 to Period 2. Therefore, as specified in the protocol, only the Period 1 results were analyzed. | percentage of subjects | NUMBER |
| SECONDARY | Onset of Action | 30 minutes after baseline treatment application on Day 15 | A carryover effect was observed from Period 1 to Period 2. Therefore, as specified in the protocol, only the Period 1 results were analyzed. All 70 enrolled subjects were analyzed for efficacy. | percentage of subjects | NUMBER |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Composite Success | CD07805/47 Gel 0.5% and Vehicle | 14.3 | percentage of subjects | ||
| Composite Success | Azelaic Acid Gel 15% | 5.7 | percentage of subjects | ||
| Onset of Action | CD07805/47 Gel 0.5 and Vehicle | 31.4 | percentage of subjects | ||
| Onset of Action | Azelaic Acid 15% | 29.4 | percentage of subjects |
Source ClinicalTrials.gov
Participant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period 1 | STARTED | CD07805/47 Gel 0.5% and Vehicle, Then Azelaic Acid Gel 15% | 35 | |
| Treatment Period 1 | STARTED | Azelaic Acid Gel 15%, Then CD07805/47 Gel 0.5% and Vehicle | 35 | |
| Treatment Period 1 | COMPLETED | CD07805/47 Gel 0.5% and Vehicle, Then Azelaic Acid Gel 15% | 35 | |
| Treatment Period 1 | COMPLETED | Azelaic Acid Gel 15%, Then CD07805/47 Gel 0.5% and Vehicle | 35 | |
| Treatment Period 1 | NOT COMPLETED | CD07805/47 Gel 0.5% and Vehicle, Then Azelaic Acid Gel 15% | 0 | |
| Treatment Period 1 | NOT COMPLETED | Azelaic Acid Gel 15%, Then CD07805/47 Gel 0.5% and Vehicle | 0 | |
| Washout , 3 to 7 Days | STARTED | CD07805/47 Gel 0.5% and Vehicle, Then Azelaic Acid Gel 15% | 35 | |
| Washout , 3 to 7 Days | STARTED | Azelaic Acid Gel 15%, Then CD07805/47 Gel 0.5% and Vehicle | 35 | |
| Washout , 3 to 7 Days | COMPLETED | CD07805/47 Gel 0.5% and Vehicle, Then Azelaic Acid Gel 15% | 33 | |
| Washout , 3 to 7 Days | COMPLETED | Azelaic Acid Gel 15%, Then CD07805/47 Gel 0.5% and Vehicle | 35 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events14
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 | Medication residue | General disorders | CD07805/47 Gel 0.5 and Vehicle | 0 | 70 | 0 |
| other | Medication residue | General disorders | Azelaic Acid 15% | 9 | 68 | 9 |
| other | Upper respiratory infection | Infections and infestations | CD07805/47 Gel 0.5 and Vehicle | 2 | 70 | 2 |
| other | Upper respiratory infection | Infections and infestations | Azelaic Acid 15% | 2 | 68 | 2 |
| other | Erythema | Skin and subcutaneous tissue disorders | CD07805/47 Gel 0.5 and Vehicle | 15 | 70 | 20 |
| other | Erythema | Skin and subcutaneous tissue disorders | Azelaic Acid 15% | 2 | 68 | 2 |
| other | Pain of skin | Skin and subcutaneous tissue disorders | CD07805/47 Gel 0.5 and Vehicle | 0 | 70 | 0 |
| other | Pain of skin | Skin and subcutaneous tissue disorders | Azelaic Acid 15% | 6 | 68 | 6 |
| other | Pruritus | Skin and subcutaneous tissue disorders | CD07805/47 Gel 0.5 and Vehicle | 1 | 70 | 1 |
| other | Pruritus | Skin and subcutaneous tissue disorders | Azelaic Acid 15% | 10 | 68 | 11 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CD07805/47 Gel 0.5 and Vehicle | ||
| Total, all-cause mortality | Azelaic Acid 15% | ||
| Total, other adverse events | CD07805/47 Gel 0.5 and Vehicle | 19 | 70 |
| Total, other adverse events | Azelaic Acid 15% | 27 | 68 |
| Total, serious adverse events | CD07805/47 Gel 0.5 and Vehicle | 0 | 70 |
| Total, serious adverse events | Azelaic Acid 15% | 0 | 68 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| CD07805/47 Gel 0.5 and Vehicle vs Azelaic Acid 15%: serious adverse events |
Source 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/NCT01659853
GET https://conductscience.org/api/trials/v1/NCT01659853/registered