A Phase 3 interventional study of Omiganan in Rosacea, sponsored by Maruho Co., Ltd.. Completed at 28 sites in 8 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-19.
Sponsored by Maruho Co., Ltd. · Phase 3, Interventional, and Treatment
This study evaluates the long-term safety of once-daily application of Omiganan topical gel in subjects with severe papulopustular rosacea.
225 studies on the registry are indexed under Rosacea; 19 are open to participants now.
This study's enrollment of 307 is above the median of 61 across 195 interventional studies indexed under Rosacea.
Browse Rosacea studies →Maruho Co., Ltd. is the lead sponsor of 24 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Omiganan gel applied once daily
Drug: Omiganan
Topical gel
Number of Subjects With 1 or More Treatment-related Treatment-Emergent Adverse Events
Number of subjects with 1 or more treatment-related Treatment-Emergent Adverse Events
Time frame: Up to 12 months
The study was conducted at 28 sites in the USA, Canada, Australia/New Zealand, and Europe from October 2015 to July 2017.
| Milestone | Treatment |
|---|---|
| Started | 307 |
| Completed | 170 |
| Not completed | 137 |
| Withdrew: Adverse event | 27 |
| Withdrew: Lost to follow-up | 22 |
| Withdrew: Physician decision | 1 |
| Withdrew: Pregnancy | 1 |
| Withdrew: Protocol violation | 3 |
| Withdrew: Withdrawal by subject | 78 |
| Withdrew: Other | 5 |
Number of subjects with 1 or more treatment-related Treatment-Emergent Adverse Events
| participants | Treatment |
|---|---|
| Number of Subjects With 1 or More Treatment-related Treatment-Emergent Adverse Events | 48 |
Collected over 378 Days. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment | 0/307 (0%) | 7/307 (2.3%) | 83/307 (27%) |
| Event | Treatment |
|---|---|
| Diabetic ketoacidosisMetabolism and nutrition disorders | 1/307 |
| DehydrationMetabolism and nutrition disorders | 1/307 |
| DizzinessNervous system disorders | 1/307 |
| Apnoeic attackRespiratory, thoracic and mediastinal disorders | 1/307 |
| EpistaxisRespiratory, thoracic and mediastinal disorders | 1/307 |
| Abdominal pain upperGastrointestinal disorders | 1/307 |
| Post concussion syndromeInjury, poisoning and procedural complications | 1/307 |
| Event | Treatment |
|---|---|
| RosaceaSkin and subcutaneous tissue disorders | 21/307 |
| HeadacheNervous system disorders | 16/307 |
| Viral upper respiratory tract infectionInfections and infestations | 12/307 |
| Application site painGeneral disorders | 10/307 |
| Upper respiratory tract infectionInfections and infestations | 9/307 |
| Application site erythemaGeneral disorders | 8/307 |
| Application site drynessGeneral disorders | 7/307 |
The 'Intent-to-treat' (ITT) analysis population included all randomized subjects.
| Age, Categorical(Participants) | Treatment |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 243 |
| >=65 years | 64 |
| Age, Continuous(years) | Treatment |
|---|---|
| Mean | 51.5 ± 13.57 |
| Sex: Female, Male(Participants) | Treatment |
|---|---|
| Female | 205 |
| Male | 102 |
| Ethnicity (NIH/OMB)(Participants) | Treatment |
|---|---|
| Hispanic or Latino | 80 |
| Not Hispanic or Latino | 227 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Treatment |
|---|---|
| American Indian or Alaska Native | 2 |
| Asian | 5 |
| Native Hawaiian or Other Pacific Islander | 1 |
| Black or African American | 1 |
| White | 286 |
| More than one race | 0 |
| Unknown or Not Reported | 12 |
| Region of Enrollment(participants) | Treatment |
|---|---|
| New Zealand | 34 |
| Canada | 24 |
| Netherlands | 1 |
| United States | 187 |
| United Kingdom | 6 |
| Australia | 37 |
| France | 18 |
Documents are hosted by the registry — open the source record to download them.
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Maruho Co., Ltd.