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Watertown, Massachusetts

  • Rosacea

Purpose:

This study evaluates the long-term safety of once-daily application of Omiganan topical gel in subjects with severe papulopustular rosacea.


Criteria:

Inclusion Criteria: 1. Healthy, male and nonpregnant female subjects, 18 years of age or older. 2. A diagnosis of severe papulopustular rosacea using the Investigator Global Assessment grading scale at baseline 3. Subjects with the presence of telangiectasia at Baseline 4. Subjects with the presence of facial erythema associated with their rosacea at Baseline Exclusion Criteria: 1. Subjects with steroid rosacea or subtype 3 (phymatous rosacea). 2. Subjects with nodular rosacea 3. Standard exclusion criteria.


Study is Available At:


Original ID:

CLS001-CO-PR-006


NCT ID:

NCT02576847


Secondary ID:


Study Acronym:


Brief Title:

Study to Evaluate the Long-term Safety of a Once-Daily Omiganan Topical Gel


Official Title:

A Phase 3 Open-Label Extension Study to Evaluate the Long-Term Safety of Omiganan Topical Gel in Subjects With Rosacea


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Cutanea Life Sciences, Inc.


Oversight Authority:

  • United States: Food and Drug Administration
  • Australia: Department of Health and Ageing Therapeutic Goods Administration
  • New Zealand: Ministry of Health
  • Canada: Health Canada
  • United Kingdom: Medicines and Healthcare Products Regulatory Agency
  • Sweden: Medical Products Agency
  • Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
  • France: Agence Nationale de Sécurité du Médicament et des produits de santé


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

307


Enrollment Type:

Actual


Study Dates

Start Date:September 2015
Completion Date:February 8, 2018
Completion Type:Actual
Primary Completion Date:July 14, 2017
Primary Completion Type:Actual
Verification Date:July 2018
Last Changed Date:July 13, 2018
First Received Date:October 13, 2015

Study Outcomes

Outcome Type:Primary Outcome
Measure:Safety Adverse Events
Time Frame:Up to 12 months
Safety Issues:False
Description:Adverse Events

Study Interventions

Intervention Type:Drug
Name:Omiganan
Description:Topical gel
Arm Name:Treatment

Study Arms

Study Arm Type:Experimental
Arm Name:Treatment
Description:Omiganan gel applied once daily

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Cutanea Life Sciences, Inc.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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