NCT00417937

Brief Summary

To assess the efficacy and tolerability of azelaic acid 15% gel applied once daily versus twice daily in the treatment of patients with papulopustular rosacea.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
98

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2007

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

January 1, 2007

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 2, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 4, 2007

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

June 9, 2023

Status Verified

February 1, 2014

Enrollment Period

5 months

First QC Date

January 2, 2007

Last Update Submit

June 8, 2023

Conditions

Papulopustular Rosacea

Outcome Measures

Primary Outcomes (1)

  • Investigator's global assessment scored on a seven point scale

    Measurements made during the course of treatment

Secondary Outcomes (1)

  • Inflammatory lesion count, erythema, telangiectasia, patient self assessment, patient opinion about therapy

    Parameters measured during the course of treatment

Study Arms (2)

1

ACTIVE COMPARATOR

Azelaic acid 15 % gel once daily

Drug: azelaic acid 15% gel

2

ACTIVE COMPARATOR

Azelaic acid 15 gel twice daily

Drug: azelaic acid 15% gel

Interventions

azelaic acid 15% gelDRUG

15% gel, topically applied once daily for six weeks

1

Eligibility Criteria

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

You may qualify if:

  • \- Papulopustular facial rosacea; minimum of 10, maximum of 50 inflamed papules and/or pustules

You may not qualify if:

  • Mild or severe rosacea
  • Rosacea with marked ocular manifestations
  • Presence of dermatoses that could interfere with the rosacea diagnosis or evaluation of the study course
  • Wash out period required for patients treated prior to study with topical retinoids, oral antibiotics, topical antibiotics, systemic and topical corticosteroids, topical imidazole, laser surgery for telangiectasia
  • History of hypersensitivity to propylene glycol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Intendis GmbH

Berlin, Germany

Location

MeSH Terms

Conditions

Rosacea

Interventions

azelaic acidGels

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

ColloidsComplex MixturesDosage FormsPharmaceutical Preparations

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2007

First Posted

January 4, 2007

Study Start

January 1, 2007

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

June 9, 2023

Record last verified: 2014-02

Locations

DE(1)