NCT00403949

Brief Summary

The purpose of this study is to test the efficacy and safety of AzA 15% Gel in the treatment of mild to moderate perioral dermatitis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

4 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

Study Start

First participant enrolled

November 1, 2006

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

November 23, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 27, 2006

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

June 9, 2023

Status Verified

February 1, 2015

Enrollment Period

4 months

First QC Date

November 23, 2006

Last Update Submit

June 8, 2023

Conditions

Perioral Dermatitis

Outcome Measures

Primary Outcomes (1)

  • The sum score derived from the most important signs and symptoms of perioral dermatitis

    Measurements and observations during the course of the study

Secondary Outcomes (2)

  • Intensity of single signs and symptoms

    Measured at scheduled visits during the course of the study

  • Safety outcomes measures will be all adverse events reported by the patients or observed by the investigator

    Safety parameters recorded at scheduled visits during the course of the study

Study Arms (2)

Azelaic acid 15% Gel

ACTIVE COMPARATOR

Azelaic acid 15%

Drug: Azelaic acid 15% gel

Placebo

PLACEBO COMPARATOR

Non-active base from Azelaic acid 15% gel

Drug: Non-active base from azelaic acid 15% gel

Interventions

Azelaic acid 15% gelDRUG

gel, applied once daily, for 6 weeks

Azelaic acid 15% Gel
Non-active base from azelaic acid 15% gelDRUG

gel, apply once daily for six weeks

Placebo

Eligibility Criteria

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

You may qualify if:

  • Clinical diagnosis of mild to moderate perioral dermatitis as diagnosed by the physician
  • Investigator's Global Assessment (IGA) score at baseline of 2 or 3 (on scale from 0 to 4)
  • to 50 facial inflammatory lesions (papules, papulopustules, papulovesicles)

You may not qualify if:

  • History of atopic dermatitis of the face
  • Granulomatous perioral dermatitis
  • Facial acne, rosacea, facial demodicosis
  • Seborrheic dermatitis of the nasolabial fold, Lupus erythematosus
  • The use of topical or systemic medications that could affect the course of treatment and/or evaluation
  • Severe diseases likely to interfere with the conduct / planned termination of the study (e.g. cancer, cardiac infarct, unstable angina pectoris, uncontrolled diabetes)
  • Use of fluorinated toothpaste
  • Planned exposure to artificial or intensive natural UV light of the test area throughout the course of the study
  • Use / planned use of cosmetic products (e.g. creams, moisturizers, make-up, fatty lipstick) in the test area during the course of the study
  • History of or suspected hypersensitivity to any ingredient of the study drugs
  • Participation in another clinical study 4 weeks prior to and/or during the conduct of this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Unknown Facility

Berlin, 10827, Germany

Location

Unknown Facility

Dülmen, 48249, Germany

Location

Unknown Facility

Essen, 45122, Germany

Location

Unknown Facility

Recklinghausen, 45661, Germany

Location

MeSH Terms

Conditions

Dermatitis, Perioral

Interventions

azelaic acidGels

Condition Hierarchy (Ancestors)

DermatitisSkin DiseasesSkin and Connective Tissue DiseasesFacial Dermatoses

Intervention Hierarchy (Ancestors)

ColloidsComplex MixturesDosage FormsPharmaceutical Preparations

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

November 23, 2006

First Posted

November 27, 2006

Study Start

November 1, 2006

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

June 9, 2023

Record last verified: 2015-02

Locations

DE(4)