Patient-Reported Outcome Of Facial Erythema (PROOF)

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Galderma

Status and phase

Completed
Phase 3

Conditions

Erythema
Rosacea

Treatments

Drug: Brimonidine tartrate was applied cutaneously once daily for 8 days.
Drug: Brimonidine tartrate vehicle was applied cutaneously once daily for 8 days.

Study type

Interventional

Funder types

Industry

Identifiers

NCT01885000
2012-005686-12 (EudraCT Number)
RD.03.SPR.29107

Details and patient eligibility

About

The purpose of the study is to evaluate the patient-reported outcomes (feedbacks of patients)of a new drug for the treatment of erythema of rosacea (central facial redness). The feedback of patients receiving the active drug will be compared to the feedback of patients receiving the placebo.

Enrollment

92 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Male or female subjects age of 18 years or older
  • A clinical diagnosis of facial rosacea
  • A Patient Self-Assessment score of 4 (severe) at Baseline prior to the study drug application
  • A Clinician's Erythema Assessment (CEA) score of 3 (moderate) or 4 (severe) at Baseline prior to the study drug application

Exclusion criteria

  • More than 5 facial inflammatory lesions (papules or pustules) of rosacea
  • Any uncontrolled chronic or serious disease or medical condition that may either interfere with the interpretation of the clinical trial results, or put the subject at significant risk if the subject participates in the clinical trial as judged by the investigator
  • Known or suspected allergies or sensitivities to any component of the study drugs, including the active ingredient brimonidine tartrate (see Investigator's Brochure)
  • Female who is pregnant or lactating

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

92 participants in 2 patient groups, including a placebo group

Brimonidine tartrate 0.5% gel
Experimental group
Description:
Participants applied brimonidine tartrate 0.5% gel topically once daily for 8 days.
Treatment:
Drug: Brimonidine tartrate was applied cutaneously once daily for 8 days.
Vehicle
Placebo Comparator group
Description:
Participants applied brimonidine tartrate vehicle gel topically once daily for 8 days.
Treatment:
Drug: Brimonidine tartrate vehicle was applied cutaneously once daily for 8 days.

Trial contacts and locations

14

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Data sourced from clinicaltrials.gov

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