Trial · NCT00855595

Efficacy of Topical Azelaic Acid 15% Gel Plus Anti-inflammatory Dose Doxycycline or Metronidazole Gel 1% Plus Anti-inflammatory Dose Doxycycline in Moderate Papulopustular Rosacea

NCT00855595, Phase 4, Completed, LEO Pharma; results first posted 2012-08-29

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy of Topical Azelaic Acid 15% Gel Plus Anti-inflammatory Dose Doxycycline or Metronidazole Gel 1% Plus Anti-inflammatory Dose Doxycycline in Moderate Papulopustular Rosacea. Trials, record NCT00855595. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00855595

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Efficacy of Topical Azelaic Acid 15% Gel Plus Anti-inflammatory Dose Doxycycline or Metronidazole Gel 1% Plus Anti-inflammatory Dose Doxycycline in Moderate Papulopustular Rosacea
NCT number: NCT00855595
Status: Completed
Phases: Phase 4
Enrollment: 207 participants, actual
Lead sponsor: LEO Pharma
Conditions: Papulopustular Rosacea
Interventions: Azelaic acid (Finacea, BAY39-6251), Metronidazole (Metrogel), Doxycycline (Oracea)
First posted: 2009-03-04
Last updated: 2020-03-31
Results first posted: 2012-08-29

Source ClinicalTrials.gov

Registered outcomes16

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Nominal Change From Baseline in Inflammatory Lesion (IL) Count (Sum of Papules and Pustules) at Week 2 (LOCF: Last Observation Carried Forward)	Baseline and Week 2	NOTE: Negative mean values represent an improvement (decrease of inflammatory lesions)
Secondary	Number of Inflammatory Lesions at Weeks 2, 4, 6, 8 and 12 (LOCF)	Week 2, 4, 6, 8 and 12
Secondary	Nominal Change From Baseline in IL Count at Weeks 4, 6, 8 and 12 (LOCF)	Baseline and Week 4, 6, 8 and 12	NOTE: Negative mean values represent an improvement (decrease of inflammatory lesions)
Secondary	Percent Change From Baseline in IL Count at Weeks 2, 4, 6, 8 and 12 (LOCF)	Baseline and Week 2, 4, 6, 8 and 12	NOTE: Negative mean values represent an improvement (decrease of inflammatory lesions)
Secondary	Percentage of Participants With at Least a 25%, 50%, or 75% Improvement in Facial IL Counts From Baseline to Weeks 2, 4, 6, 8 and 12 (LOCF)	Baseline and Weeks 2, 4, 6, 8 and 12
Secondary	Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at Weeks 2, 4, 6, 8 and 12 (LOCF)	Weeks 2, 4, 6, 8 and 12	IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information) / Therapeutic success is defined as an IGA score of clear or minimal (0 or 1).
Secondary	Percentage of Participants With IGA Based Patient Response at Weeks 2, 4, 6, 8 and 12 (LOCF)	Weeks 2, 4, 6, 8 and 12	IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information) / Patient response is defined as an IGA score of clear, minimal, or mild (0, 1, or 2)
Secondary	Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 2	At Week 2	IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information).
Secondary	Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 4	At Week 4	IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information).
Secondary	Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 6	At Week 6	IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information).

1 to 10 of 16Source ClinicalTrials.gov

See all 16 registered outcomes

Outcomes16

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Nominal Change From Baseline in Inflammatory Lesion (IL) Count (Sum of Papules and Pustules) at Week 2 (LOCF: Last Observation Carried Forward)	Baseline and Week 2	Full analysis set (FAS)	Inflammatory lesions	MEAN
SECONDARY	Number of Inflammatory Lesions at Weeks 2, 4, 6, 8 and 12 (LOCF)	Week 2, 4, 6, 8 and 12	FAS	Inflammatory lesions	MEAN
SECONDARY	Nominal Change From Baseline in IL Count at Weeks 4, 6, 8 and 12 (LOCF)	Baseline and Week 4, 6, 8 and 12	FAS	Inflammatory lesions	MEAN
SECONDARY	Percent Change From Baseline in IL Count at Weeks 2, 4, 6, 8 and 12 (LOCF)	Baseline and Week 2, 4, 6, 8 and 12	FAS	Percent of inflammatory lesions	MEAN
SECONDARY	Percentage of Participants With at Least a 25%, 50%, or 75% Improvement in Facial IL Counts From Baseline to Weeks 2, 4, 6, 8 and 12 (LOCF)	Baseline and Weeks 2, 4, 6, 8 and 12	FAS	Percentage of participants	NUMBER
SECONDARY	Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at Weeks 2, 4, 6, 8 and 12 (LOCF)	Weeks 2, 4, 6, 8 and 12	FAS	Percentage of participants	NUMBER
SECONDARY	Percentage of Participants With IGA Based Patient Response at Weeks 2, 4, 6, 8 and 12 (LOCF)	Weeks 2, 4, 6, 8 and 12	FAS	Percentage of participants	NUMBER
SECONDARY	Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 2	At Week 2	FAS	Percentage of participants	NUMBER
SECONDARY	Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 4	At Week 4	FAS	Percentage of participants	NUMBER
SECONDARY	Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 6	At Week 6	FAS	Percentage of participants	NUMBER

1 to 10 of 16Source ClinicalTrials.gov

See all 16 outcomes

Results by group190

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Nominal Change From Baseline in Inflammatory Lesion (IL) Count (Sum of Papules and Pustules) at Week 2 (LOCF: Last Observation Carried Forward)	Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)		-10.5	Standard Deviation 9.14	Inflammatory lesions
Nominal Change From Baseline in Inflammatory Lesion (IL) Count (Sum of Papules and Pustules) at Week 2 (LOCF: Last Observation Carried Forward)	Metronidazole (Metrogel) Plus Doxycycline (Oracea)		-9.4	Standard Deviation 9.38	Inflammatory lesions
Number of Inflammatory Lesions at Weeks 2, 4, 6, 8 and 12 (LOCF)	Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)	Week 2	10.1	Standard Deviation 8.70	Inflammatory lesions
Number of Inflammatory Lesions at Weeks 2, 4, 6, 8 and 12 (LOCF)	Metronidazole (Metrogel) Plus Doxycycline (Oracea)	Week 2	12.5	Standard Deviation 9.86	Inflammatory lesions
Number of Inflammatory Lesions at Weeks 2, 4, 6, 8 and 12 (LOCF)	Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)	Week 4	7.4	Standard Deviation 7.29	Inflammatory lesions
Number of Inflammatory Lesions at Weeks 2, 4, 6, 8 and 12 (LOCF)	Metronidazole (Metrogel) Plus Doxycycline (Oracea)	Week 4	9.5	Standard Deviation 8.09	Inflammatory lesions
Number of Inflammatory Lesions at Weeks 2, 4, 6, 8 and 12 (LOCF)	Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)	Week 6	5.9	Standard Deviation 6.28	Inflammatory lesions
Number of Inflammatory Lesions at Weeks 2, 4, 6, 8 and 12 (LOCF)	Metronidazole (Metrogel) Plus Doxycycline (Oracea)	Week 6	7.8	Standard Deviation 7.18	Inflammatory lesions
Number of Inflammatory Lesions at Weeks 2, 4, 6, 8 and 12 (LOCF)	Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)	Week 8	5.1	Standard Deviation 6.28	Inflammatory lesions
Number of Inflammatory Lesions at Weeks 2, 4, 6, 8 and 12 (LOCF)	Metronidazole (Metrogel) Plus Doxycycline (Oracea)	Week 8	6.4	Standard Deviation 7.02	Inflammatory lesions

1 to 10 of 190Source ClinicalTrials.gov

See all 190 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)	106
Overall Study	STARTED	Metronidazole (Metrogel) Plus Doxycycline (Oracea)	101
Overall Study	COMPLETED	Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)	100
Overall Study	COMPLETED	Metronidazole (Metrogel) Plus Doxycycline (Oracea)	94
Overall Study	NOT COMPLETED	Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)	6
Overall Study	NOT COMPLETED	Metronidazole (Metrogel) Plus Doxycycline (Oracea)	7

Source ClinicalTrials.gov

Adverse events118

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	Ear congestion	Ear and labyrinth disorders	Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)	1	106	1
other	Ear congestion	Ear and labyrinth disorders	Metronidazole (Metrogel) Plus Doxycycline (Oracea)	0	101	0
other	Ear discomfort	Ear and labyrinth disorders	Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)	1	106	1
other	Ear discomfort	Ear and labyrinth disorders	Metronidazole (Metrogel) Plus Doxycycline (Oracea)	0	101	0
other	Diabetes mellitus	Endocrine disorders	Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)	1	106	1
other	Diabetes mellitus	Endocrine disorders	Metronidazole (Metrogel) Plus Doxycycline (Oracea)	0	101	0
other	Hypothyroidism	Endocrine disorders	Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)	0	106	0
other	Hypothyroidism	Endocrine disorders	Metronidazole (Metrogel) Plus Doxycycline (Oracea)	1	101	1
other	Conjunctivitis	Eye disorders	Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)	1	106	1
other	Conjunctivitis	Eye disorders	Metronidazole (Metrogel) Plus Doxycycline (Oracea)	0	101	0

1 to 10 of 118Source ClinicalTrials.gov

See all 118 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)
Total, all-cause mortality	Metronidazole (Metrogel) Plus Doxycycline (Oracea)
Total, other adverse events	Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)	29	106
Total, other adverse events	Metronidazole (Metrogel) Plus Doxycycline (Oracea)	33	101
Total, serious adverse events	Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)	0	106
Total, serious adverse events	Metronidazole (Metrogel) Plus Doxycycline (Oracea)	1	101

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
20645521	RESULT

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 comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea) vs Metronidazole (Metrogel) Plus Doxycycline (Oracea): 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT00855595

GET https://conductscience.org/api/trials/v1/NCT00855595/results?page=2

API reference For AI assistants