Study to Evaluate the Safety and Efficacy of a Once-Daily CLS001 Topical Gel Versus Vehicle

Rosacea Clinical Trial

Official title:

A Phase 3, Randomized, Vehicle-Controlled, Double-Blind, Multicenter Study to Evaluate the Safety and Efficacy of Once-Daily CLS001 Topical Gel Versus Vehicle Administered for 12 Weeks to Subjects With Papulopustular Rosacea With a 4 Week Follow-up Period

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02576860
• Other study ID #: CLS001-CO-PR-005
• Status: Completed
• Phase: Phase 3
• Start date: October 2015
• Est. completion date: September 5, 2017

Study information

• Verified date: July 2022
• Source: Maruho Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates the safety and efficacy of once-daily application of CLS001 topical gel compared to vehicle gel in subjects with severe papulopustular rosacea.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 263
• Est. completion date: September 5, 2017
• Est. primary completion date: February 27, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Healthy, male and non-pregnant female subjects, 18 years of age or older.

2. A diagnosis of papulopustular rosacea with =30 inflammatory facial lesions at Baseline. Subjects must have no more than 2 nodular lesions, at Baseline.

3. Subjects with the presence of telangiectasia at Baseline.

4. Subjects with an erythema score of at least 2 on the Investigator Assessment of Erythema scale at Baseline.

5. Subjects with severe rosacea on the Investigators Global Assessment scale at Baseline.

Exclusion Criteria:

1. Subjects with steroid rosacea or subtype 3 (phymatous rosacea).

2. Subjects with nodular rosacea.

3. Standard exclusion criteria.

Related Conditions & MeSH terms

• Rosacea

Intervention

Drug:
• CLS001 (Omiganan)
Topical gel
• Vehicle
Vehicle gel

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Maruho Co., Ltd.

Countries where clinical trial is conducted

United States,  Australia,  Canada,  France,  Germany,  Netherlands,  New Zealand,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety Adverse Events	Subjects with 1 or more treatment-related Treatment-Emergent Adverse Events	12 weeks
Primary	Efficacy Absolute Change in Inflammatory Lesion Count	Absolute change in inflammatory lesion count from baseline to Week 12.	12 weeks
Primary	Efficacy IGA: 2 Grade Reduction	Proportion of Subjects Who Achieved 2 Grade IGA Reduction at Week 12. IGA scores are from 0 to 5 (Clear, Almost Clear, Mild, Moderate and Severe).	12 weeks
Secondary	Efficacy The Absolute Change in Inflammatory Lesions	The absolute change in inflammatory lesions from baseline to Week 9.	9 weeks
Secondary	Efficacy The Absolute Change in Inflammatory Lesions	The absolute change in inflammatory lesions from baseline to Week 6.	6 weeks
Secondary	Efficacy IGA: 2 Point Reduction	Proportion of Subjects Who Achieved 2 Grade IGA Reduction at Week 9. IGA scores are from 0 to 5 (Clear, Almost Clear, Mild, Moderate and Severe).	9 Weeks
Secondary	Efficacy IGA: 2 Point Reduction	Proportion of Subjects Who Achieved 2 Grade IGA Reduction at Week 6. IGA scores are from 0 to 5 (Clear, Almost Clear, Mild, Moderate and Severe).	6 Weeks