Trial · NCT03075891
Oracea Soolantra Association in Participants With Severe Rosacea
NCT03075891, Phase 4, Completed, Galderma R&D; results first posted 2019-11-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Oracea Soolantra Association in Participants With Severe Rosacea. Trials, record NCT03075891. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03075891
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Oracea Soolantra Association in Participants With Severe Rosacea
- NCT number
- NCT03075891
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 273 participants, actual
- Lead sponsor
- Galderma R&D
- Conditions
- Rosacea
- Interventions
- Ivermectin 1% cream, Doxycycline 40 mg MR (30 mg Immediate Release & 10 mg Delayed Release beads) capsules, Oral placebo capsules
- First posted
- 2017-03-09
- Last updated
- 2021-03-16
- Results first posted
- 2019-11-29
Source ClinicalTrials.gov
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline in Inflammatory Lesion Count at Week 12 | Baseline, Week 12 | Percent change from baseline in inflammatory lesion count at week 12 was reported. Inflammatory lesions included facial inflammatory lesions of rosacea (that is \[i.e.\] papules and pustules) which were defined as follows: Papule - a small, solid elevation less than 1.0 centimeter (cm) in diameter; and Pustule - a small, circumscribed elevation of the skin, which contains yellow white exudates. Papules and pustules were counted separately on each of the 5 facial regions (forehead, chin, nose, right cheek and left cheek). Notably, nodules (i.e. circumscribed, elevated, solid lesions more than 1.0 cm in diameter with palpable depth) were not included in the count of inflammatory lesions. |
| Secondary | Percent Change From Baseline in Inflammatory Lesion Count at Weeks 4 and 8 | Baseline, Weeks 4 and 8 | Percent change from baseline in inflammatory lesion count at Weeks 4 and 8 was reported. Inflammatory lesions included facial inflammatory lesions of rosacea (i.e. papules and pustules) which were defined as follows: Papule - a small, solid elevation less than 1.0 centimeter in diameter. Pustule - a small, circumscribed elevation of the skin, which contains yellow white exudates. Papules and pustules were counted separately on each of the 5 facial regions (forehead, chin, nose, right cheek and left cheek). Notably, nodules (i.e. circumscribed, elevated, solid lesions more than 1.0 cm in diameter with palpable depth) were not included in the count of inflammatory lesions. |
| Secondary | Percentage of Participants With Clear Inflammatory Lesions at Week 12 | Week 12 | Percentage of participants with clear inflammatory lesions at week 12 was reported. Inflammatory lesions included facial inflammatory lesions of rosacea (i.e. papules and pustules) which were defined as follows: Papule - a small, solid elevation less than 1.0 cm in diameter. Pustule - a small, circumscribed elevation of the skin, which contains yellow white exudates. Papules and pustules were counted separately on each of the 5 facial regions (forehead, chin, nose, right cheek and left cheek). Notably, nodules (i.e. circumscribed, elevated, solid lesions more than 1.0 cm in diameter with palpable depth) were not included in the count of inflammatory lesions. |
| Secondary | Percentage of Participants With 100 Percent (%) Reduction in Inflammatory Lesions at Weeks 4, 8 and 12 | Weeks 4, 8 and 12 | Percentage of participants with 100% reduction in inflammatory lesions at Weeks 4, 8 and 12 was reported. Inflammatory lesions included facial inflammatory lesions of rosacea (i.e. papules and pustules) which were defined as follows: Papule - a small, solid elevation less than 1.0 centimeter in diameter. Pustule - a small, circumscribed elevation of the skin, which contains yellow white exudates. Papules and pustules were counted separately on each of the 5 facial regions (forehead, chin, nose, right cheek and left cheek). Notably, nodules (i.e. circumscribed, elevated, solid lesions more than 1.0 cm in diameter with palpable depth) were not included in the count of inflammatory lesions. |
| Secondary | Clinician's Erythema Assessment (CEA) Total Score at Weeks 4, 8 and 12 | Weeks 4, 8 and 12 | The evaluator assessed the participant's diffuse persistent facial erythema of rosacea by performing a static ("snap shot") evaluation of erythema severity at a social distance of approximately 50 centimeter (cm) using CEA scale, at each visit. CEA is a 5 point scale where 0 = clear (clear skin with no signs of erythema); 1 = almost clear (almost clear; slight redness); 2 = mild (mild erythema; definite redness); 3 = moderate (moderate erythema; marked redness); 4 = severe (severe erythema; fiery redness). A higher score than baseline indicates a worse outcome. |
| Secondary | Percentage of Participants in Each Clinician's Erythema Assessment Score Category at Weeks 4, 8 and 12 | Weeks 4, 8 and 12 | The evaluator assessed the participant's diffuse persistent facial erythema of rosacea by performing a static ("snap shot") evaluation of erythema severity at a social distance of approximately 50 centimeter (cm) using CEA scale, at each visit. CEA is a 5 point scale where 0 = clear (clear skin with no signs of erythema); 1 = almost clear (almost clear; slight redness); 2 = mild (mild erythema; definite redness); 3 = moderate (moderate erythema; marked redness); 4 = severe (severe erythema; fiery redness). A higher score than baseline indicates a worse outcome. |
| Secondary | Investigator's Global Assessment (IGA) Total Score at Weeks 4, 8 and 12 | Weeks 4, 8 and 12 | The evaluator assessed the participant's rosacea by performing a static ("snap shot") evaluation, at a social distance of approximately 50 cm, using the IGA score. IGA is a 5 point scale where, 0 = clear (no inflammatory lesions present, no erythema); 1 = almost clear (very small papules/pustules, very mild erythema present); 2 = mild (few small papules/pustules, mild erythema); 3 = moderate (severe small or large papules/pustules, moderate erythema); 4 = severe (numerous small and/or large papules/pustules, severe erythema). |
| Secondary | Percentage of Participants in Each Investigator's Global Assessment Score Category at Weeks 4, 8 and 12 | Weeks 4, 8 and 12 | The evaluator assessed the participant's rosacea by performing a static ("snap shot") evaluation, at a social distance of approximately 50 cm, using the IGA score. IGA is a 5 point scale where, 0 = clear (no inflammatory lesions present, no erythema); 1 = almost clear (very small papules/pustules, very mild erythema present); 2 = mild (few small papules/pustules, mild erythema); 3 = moderate (severe small or large papules/pustules, moderate erythema); 4 = severe (numerous small and/or large papules/pustules, severe erythema). |
| Secondary | Stinging/Burning Severity Score at Weeks 4, 8 and 12 | Weeks 4, 8 and 12 | The evaluator recorded the severity of the participant's facial stinging/burning sensation during the last 24 hours according to the stinging/burning scale. Stinging/burning scale is a 4 point scale where, 0 = none (No stinging/burning ); 1 = mild (slight warm, tingling/stinging sensation, not really bothersome); 2 = moderate (definite warm, tingling/stinging sensation that is somewhat bothersome); 3 = severe (hot, tingling/stinging sensation that has caused definite discomfort). |
| Secondary | Percentage of Participants in Each Stinging/Burning Severity Score Category at Weeks 4, 8 and 12 | Weeks 4, 8 and 12 | The evaluator recorded the severity of the participant's facial stinging/burning sensation during the last 24 hours according to the stinging/burning scale. Stinging/burning scale is a 4 point scale where, 0 = none (No stinging/burning ); 1 = mild (slight warm, tingling/stinging sensation, not really bothersome); 2 = moderate (definite warm, tingling/stinging sensation that is somewhat bothersome); 3 = severe (hot, tingling/stinging sensation that has caused definite discomfort). |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 registered outcomesOutcomes25
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change From Baseline in Inflammatory Lesion Count at Week 12 | Baseline, Week 12 | Intent-to-treat (ITT) population consisted of the entire population enrolled and randomized. The last observation carried forward (LOCF) method was used to impute missing values for inflammatory lesion count. | percent change | MEAN |
| SECONDARY | Percent Change From Baseline in Inflammatory Lesion Count at Weeks 4 and 8 | Baseline, Weeks 4 and 8 | ITT population consisted of the entire population enrolled and randomized. The LOCF method was used to impute missing values for inflammatory lesion count. | percent change | MEAN |
| SECONDARY | Percentage of Participants With Clear Inflammatory Lesions at Week 12 | Week 12 | ITT population consisted of the entire population enrolled and randomized. The LOCF method was used to impute missing values for inflammatory lesion count. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With 100 Percent (%) Reduction in Inflammatory Lesions at Weeks 4, 8 and 12 | Weeks 4, 8 and 12 | ITT population consisted of the entire population enrolled and randomized. The LOCF method was used to impute missing values for inflammatory lesion count. | percentage of participants | NUMBER |
| SECONDARY | Clinician's Erythema Assessment (CEA) Total Score at Weeks 4, 8 and 12 | Weeks 4, 8 and 12 | ITT population consisted of the entire population enrolled and randomized. The LOCF method was used to impute missing values for inflammatory lesion count. | Units on a scale | MEAN |
| SECONDARY | Percentage of Participants in Each Clinician's Erythema Assessment Score Category at Weeks 4, 8 and 12 | Weeks 4, 8 and 12 | ITT population consisted of the entire population enrolled and randomized. The LOCF method was used to impute missing values for inflammatory lesion count. | percentage of participants | NUMBER |
| SECONDARY | Investigator's Global Assessment (IGA) Total Score at Weeks 4, 8 and 12 | Weeks 4, 8 and 12 | ITT population consisted of the entire population enrolled and randomized. The LOCF method was used to impute missing values for inflammatory lesion count. | Units on a scale | MEAN |
| SECONDARY | Percentage of Participants in Each Investigator's Global Assessment Score Category at Weeks 4, 8 and 12 | Weeks 4, 8 and 12 | ITT population consisted of the entire population enrolled and randomized. The LOCF method was used to impute missing values for inflammatory lesion count. | percentage of participants | NUMBER |
| SECONDARY | Stinging/Burning Severity Score at Weeks 4, 8 and 12 | Weeks 4, 8 and 12 | ITT population consisted of the entire population enrolled and randomized. The LOCF method was used to impute missing values. | units on a scale | MEAN |
| SECONDARY | Percentage of Participants in Each Stinging/Burning Severity Score Category at Weeks 4, 8 and 12 | Weeks 4, 8 and 12 | ITT population consisted of the entire population enrolled and randomized. The LOCF method was used to impute missing values. | percentage of participants | NUMBER |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 outcomesResults by group262
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change From Baseline in Inflammatory Lesion Count at Week 12 | Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules | -80.29 | Standard Deviation 21.65 | percent change | |
| Percent Change From Baseline in Inflammatory Lesion Count at Week 12 | Ivermectin 1% Cream + Oral Placebo Capsules | -73.56 | Standard Deviation 30.52 | percent change | |
| Percent Change From Baseline in Inflammatory Lesion Count at Weeks 4 and 8 | Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules | Week 4 | -48.15 | Standard Deviation 26.71 | percent change |
| Percent Change From Baseline in Inflammatory Lesion Count at Weeks 4 and 8 | Ivermectin 1% Cream + Oral Placebo Capsules | Week 4 | -39.27 | Standard Deviation 27.93 | percent change |
| Percent Change From Baseline in Inflammatory Lesion Count at Weeks 4 and 8 | Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules | Week 8 | -69.14 | Standard Deviation 24.10 | percent change |
| Percent Change From Baseline in Inflammatory Lesion Count at Weeks 4 and 8 | Ivermectin 1% Cream + Oral Placebo Capsules | Week 8 | -61.44 | Standard Deviation 28.74 | percent change |
| Percentage of Participants With Clear Inflammatory Lesions at Week 12 | Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules | 17.8 | percentage of participants | ||
| Percentage of Participants With Clear Inflammatory Lesions at Week 12 | Ivermectin 1% Cream + Oral Placebo Capsules | 7.2 | percentage of participants | ||
| Percentage of Participants With 100 Percent (%) Reduction in Inflammatory Lesions at Weeks 4, 8 and 12 | Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules | Week 4: Yes | 1.5 | percentage of participants | |
| Percentage of Participants With 100 Percent (%) Reduction in Inflammatory Lesions at Weeks 4, 8 and 12 | Ivermectin 1% Cream + Oral Placebo Capsules | Week 4: Yes | 0.0 | percentage of participants |
1 to 10 of 262Source ClinicalTrials.gov
See all 262 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules | 135 | |
| Overall Study | STARTED | Ivermectin 1% Cream + Oral Placebo Capsules | 138 | |
| Overall Study | COMPLETED | Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules | 126 | |
| Overall Study | COMPLETED | Ivermectin 1% Cream + Oral Placebo Capsules | 125 | |
| Overall Study | NOT COMPLETED | Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules | 9 | |
| Overall Study | NOT COMPLETED | Ivermectin 1% Cream + Oral Placebo Capsules | 13 |
Source ClinicalTrials.gov
Adverse events26
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 | Diarrhoea | Gastrointestinal disorders | Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules | 1 | 135 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | Ivermectin 1% Cream + Oral Placebo Capsules | 6 | 138 | 6 |
| other | Nausea | Gastrointestinal disorders | Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules | 0 | 135 | 0 |
| other | Nausea | Gastrointestinal disorders | Ivermectin 1% Cream + Oral Placebo Capsules | 2 | 138 | 2 |
| other | Gastroenteritis | Infections and infestations | Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules | 0 | 135 | 0 |
| other | Gastroenteritis | Infections and infestations | Ivermectin 1% Cream + Oral Placebo Capsules | 3 | 138 | 3 |
| other | Nasopharyngitis | Infections and infestations | Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules | 6 | 135 | 6 |
| other | Nasopharyngitis | Infections and infestations | Ivermectin 1% Cream + Oral Placebo Capsules | 10 | 138 | 10 |
| other | Rhinitis | Infections and infestations | Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules | 0 | 135 | 0 |
| other | Rhinitis | Infections and infestations | Ivermectin 1% Cream + Oral Placebo Capsules | 2 | 138 | 2 |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules | 0 | 135 |
| Total, all-cause mortality | Ivermectin 1% Cream + Oral Placebo Capsules | 0 | 138 |
| Total, other adverse events | Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules | 17 | 135 |
| Total, other adverse events | Ivermectin 1% Cream + Oral Placebo Capsules | 33 | 138 |
| Total, serious adverse events | Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules | 1 | 135 |
| Total, serious adverse events | Ivermectin 1% Cream + Oral Placebo Capsules | 1 | 138 |
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 |
|---|---|
| Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules vs Ivermectin 1% Cream + Oral Placebo Capsules: deaths from any cause | Trial comparisons |
| Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules vs Ivermectin 1% Cream + Oral Placebo Capsules: 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/NCT03075891
GET https://conductscience.org/api/trials/v1/NCT03075891/registered?page=2