NCT00940992

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 17, 2009

Completed
2.5 years until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
2 years until next milestone

Results Posted

Study results publicly available

January 9, 2015

Completed
Last Updated

January 9, 2015

Status Verified

December 1, 2014

Enrollment Period

8 months

First QC Date

July 14, 2009

Results QC Date

December 18, 2014

Last Update Submit

December 31, 2014

Conditions

Rosacea

Outcome Measures

Primary Outcomes (2)

  • 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).

    Baseline to Week 12 / end of treatment

  • Change in Inflammatory Lesion Counts From Baseline

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

    Baseline to Week 12 / end of treatment

Study Arms (3)

DER 45 EV Gel, 1%

EXPERIMENTAL

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

Drug: DER 45 EV

Vehicle

PLACEBO COMPARATOR

Placebo Gel applied topically once a day for 12 weeks

Drug: Vehicle

DER 45 EV Gel, 5%

EXPERIMENTAL

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

Drug: DER 45 EV

Interventions

DER 45 EVDRUG

Topical application to face for 12 weeks

DER 45 EV Gel, 1%DER 45 EV Gel, 5%
VehicleDRUG

Topical application to face for 12 weeks

Vehicle

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Baumann Cosmetic & Research Institute

Miami, Florida, 33140, United States

Location

FXM Research Corp

Miami, Florida, 33175, United States

Location

Augusta Centre for Dermatology and Skin

Augusta, Georgia, 30909, United States

Location

Minnesota Clinical Study Center

Fridley, Minnesota, 55432, United States

Location

Skin Search of Rochester, Inc

Rochester, New York, 14623, United States

Location

Tennessee Clinical Research Center

Nashville, Tennessee, 37215, United States

Location

DermResearch, Inc

Austin, Texas, 78759, United States

Location

J & S Studies, Inc

College Station, Texas, 77840, United States

Location

Premier Clinical Research

Spokane, Washington, 99204, United States

Location

Madison Skin and Research, Inc

Madison, Wisconsin, 53719, United States

Location

MeSH Terms

Conditions

Rosacea

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
Ofra Levy-Hacham, Ph.D, VP of Quality Assurance
Organization
Solgel
ofra.levy-hacham@sol-gel.com
972-8-9313433

Study Officials

  • Ofra Levy-Hacham, PhD

    Sponsor GmbH

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2009

First Posted

July 17, 2009

Study Start

January 1, 2012

Primary Completion

September 1, 2012

Study Completion

January 1, 2013

Last Updated

January 9, 2015

Results First Posted

January 9, 2015

Record last verified: 2014-12

Locations

US(10)