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Completed

NCT Number: NCT00940992

A Study of DER 45-EV Gel to Treat Rosacea

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

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Key information

Conditions

Rosacea Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Baumann Cosmetic & Research Institute, Miami, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DER 45 EV

Drug

Topical application to face for 12 weeks

Vehicle

Drug

Topical application to face for 12 weeks

Primary outcomes

  1. Investigator Global Assessment (IGA) Improvement From Baseline

    Time frame: 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).

  2. Change in Inflammatory Lesion Counts From Baseline

    Time frame: Baseline to Week 12 / end of treatment

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

Sponsors and collaborators

Lead sponsor

Sol-Gel Technologies, Ltd.

Industry

Registry information

Official study title

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

Acronym: SGTDER45EV

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Jul 17, 2009
Registry last updated
Jan 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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