Phase 2 Completed N=92 Randomized Triple-blind Treatment

A Study of DER 45-EV Gel to Treat Rosacea

Source: ClinicalTrials.gov NCT00940992 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2015

Primary outcomePrimary: Investigator Global Assessment (IGA) Improvement From Baseline — 37.5; 20.0; 53.3 percentage of subjects

Summary

To identify lowest efficacious dose of DER 45 EV Gel, 1% and 5% verses vehicle in patients with rosacea.

Outcome Measures

Outcome	Result	p-value
PRIMARY Investigator Global Assessment (IGA) Improvement From Baseline	37.5; 20.0; 53.3	—
PRIMARY Change in Inflammatory Lesion Counts From Baseline	-21.5; -8.8; -14.7	—

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00940992). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.