Title

A Study of DER 45-EV Gel to Treat Rosacea
A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Dose-Range Study of DER 45 EV Gel, 1% and 5%, and Vehicle Gel in the Treatment of Rosacea
  • Phase

    Phase 2
  • Study Type

    Interventional
  • Study Participants

    92
To identify lowest efficacious dose of DER 45 EV Gel, 1% and 5% verses vehicle in patients with rosacea.
Study Started
Jan 31
2012
Primary Completion
Sep 30
2012
Study Completion
Jan 31
2013
Results Posted
Jan 09
2015
Estimate
Last Update
Jan 09
2015
Estimate

Drug DER 45 EV

Topical application to face for 12 weeks

Drug Vehicle

Topical application to face for 12 weeks

DER 45 EV Gel, 1% Experimental

DER 45 EV Gel, 1% topically applied once daily to face for 12 weeks

Vehicle Placebo Comparator

Placebo Gel applied topically once a day for 12 weeks

DER 45 EV Gel, 5% Experimental

DER 45 EV Gel, 5% applied topically once a day for 12 weeks

Criteria

Inclusion Criteria:

Males and females, 18 years of age or older
Facial rosacea, with 12 or more inflammatory lesions (with no more than 2 nodules)
Mild, Moderate or Severe (2, 3 or 4) rating of rosacea on the IGA
Females of child-bearing potential must have negative urine pregnancy test result at baseline and must be willing to use an effective form of contraception throughout the study

Exclusion Criteria:

Subjects who are pregnant, breast feeding, or planning a pregnancy during the study
Allergy or sensitivity to ingredients in test product
Any dermatological conditions of the face that may interfere with study evaluations
Subjects unable to avoid or minimize exposure to factors that may exacerbate or trigger rosacea

Summary

DER 45 EV Gel, 1%

Vehicle

DER 45 EV Gel, 5%

All Events

Event Type Organ System Event Term DER 45 EV Gel, 1% Vehicle DER 45 EV Gel, 5%

Investigator Global Assessment (IGA) Improvement From Baseline

The proportions of subjects with the primary measure of success at week 12 /end of study ,defined as a 2-grade improvement in the IGA (Investigator Global Assessment) relative to Baseline. The Investigator Global Assessment grades are: Grade 0 (Clear), Grade 1 (Almost Clear), Grade 2 (Mild), Grade 3 (Moderate) and Grade 4 (Severe).

DER 45 EV Gel, 1%

37.5
percentage of subjects

Vehicle

20.0
percentage of subjects

DER 45 EV Gel, 5%

53.3
percentage of subjects

Change in Inflammatory Lesion Counts From Baseline

The LS mean changes from Baseline in inflammatory lesion count at Week 12.

DER 45 EV Gel, 1%

-21.5
Inflammatory lesions (Least Squares Mean)
95% Confidence Interval: -27.5 to -15.4

Vehicle

-8.8
Inflammatory lesions (Least Squares Mean)
95% Confidence Interval: -15.1 to -2.5

DER 45 EV Gel, 5%

-14.7
Inflammatory lesions (Least Squares Mean)
95% Confidence Interval: -21.0 to -8.4

Total

92
Participants

Age, Continuous

51.2
years (Mean)
Standard Deviation: 12.80

number of inflammatory lesions

23.9
number of inflammatory lesion (Mean)
Standard Deviation: 19.76

Region of Enrollment

Sex: Female, Male

Overall Study

DER 45 EV Gel, 1%

Vehicle

DER 45 EV Gel, 5%

Drop/Withdrawal Reasons

DER 45 EV Gel, 1%

Vehicle

DER 45 EV Gel, 5%