A Twelve Week Safety and Efficacy Study in Rosacea

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Maruho

Status and phase

Completed
Phase 2

Conditions

Papulopustular Rosacea

Treatments

Drug: placebo
Drug: omiganan

Study type

Interventional

Funder types

Industry

Identifiers

NCT01784133
CLS001-CO-PR-001

Details and patient eligibility

About

The purpose of this study is to evaluate th safety and efficacy of one-daily topical application of CLS001 low, mid and high dose compared to vehicle gel in subjects with papulopustular rosacea.

Enrollment

240 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • diagnosis of papulopustular rosacea (at least 15 lesions)

Exclusion criteria

  • nodular rosacea or subtype 3
  • clinically significant abnormal findings that would interfere with study objectives

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

240 participants in 4 patient groups, including a placebo group

omiganan mid dose
Active Comparator group
Description:
omiganan mid dose once daily application for 12 weeks
Treatment:
Drug: omiganan
omiganan high dose
Active Comparator group
Description:
omiganan high dose once daily application for 12 weeks
Treatment:
Drug: omiganan
Vehicle group
Placebo Comparator group
Description:
Vehicle once daily application for 12 weeks
Treatment:
Drug: placebo
omiganan low dose
Active Comparator group
Description:
omiganan low dose once daily application for 12 weeks
Treatment:
Drug: omiganan

Trial contacts and locations

17

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Data sourced from clinicaltrials.gov

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