A Study of DER 45-EV Gel to Treat Rosacea

• DER 45 EV (Drug): Topical application to face for 12 weeks
• Vehicle (Drug): Topical application to face for 12 weeks

Primary outcomes

• Investigator Global Assessment (IGA) Improvement From Baseline [Baseline to Week 12 / end of treatment]: 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).
• Change in Inflammatory Lesion Counts From Baseline [Baseline to Week 12 / end of treatment]: The LS mean changes from Baseline in inflammatory lesion count at Week 12.

Sex: All, ages: 18 Years to any

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

Participant flow

Outcome results

• Investigator Global Assessment (IGA) Improvement From Baseline (Primary), Number, percentage of subjects: DER 45 EV Gel, 1% 37.5; Vehicle 20.0; DER 45 EV Gel, 5% 53.3
• Change in Inflammatory Lesion Counts From Baseline (Primary), Least squares mean, Inflammatory lesions: DER 45 EV Gel, 1% -21.5 (-27.5 to -15.4); Vehicle -8.8 (-15.1 to -2.5); DER 45 EV Gel, 5% -14.7 (-21.0 to -8.4)

Adverse events

Time frame: 12 weeks

Other adverse events by term

• Ofra Levy-Hacham, PhD, Study director, Sponsor GmbH