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| Sponsor: | Intendis GmbH |
|---|---|
| Information provided by: | Intendis GmbH |
| ClinicalTrials.gov Identifier: | NCT00031096 |
Purpose
Comparison of efficacy and safety of Azelaic Acid 15% gel with its vehicle in male and female patients with mild to moderate acne.
Qualified subjects will apply the gel to their face twice a day for a period of 12 weeks. Subjects will be required to return to the doctor's office for up to 5 visits.
| Condition | Intervention | Phase |
|---|---|---|
|
Acne Vulgaris |
Drug: Azelaic Acid Gel 15% (Finacea, BAY39-6251) Drug: Vehicle gel (SH H 655 PBA) |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A 12-week, Randomized, Double-blind, Multicenter Study Comparing the Clinical Efficacy and Safety of Azelaic Acid 15% Gel (SH H 655 BA) With Its Vehicle (SH H 655 PBA) in Patients With Mild to Moderate Acne. |
| Enrollment: | 879 |
| Study Start Date: | January 2002 |
| Study Completion Date: | July 2002 |
| Arms | Assigned Interventions |
|---|---|
| Arm 1: Experimental |
Drug: Azelaic Acid Gel 15% (Finacea, BAY39-6251)
Azelaic Acid 15% gel (SH H 655 BA) applied topically two times per day.
|
| Arm 2: Placebo Comparator |
Drug: Vehicle gel (SH H 655 PBA)
Vehicle gel (SH H 655 PBA) applied topically two times per day.
|
Acne is a common inflammatory skin condition characterized by skin eruptions around hair follicles. People with acne can have pustules (zits or pimples), papules, whiteheads or blackheads, nodules, and redness of the skin. Acne usually involves the face and shoulders, but can also involve the chest, arms, and legs. The purpose of this study is to evaluate the safety and effectiveness of an investigational gel containing active medication compared to the same gel without any active medication (placebo or vehicle) in subjects with mild to moderate facial acne.
This study has initially been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.
Intendis Inc., a Bayer HealthCare company, is the sponsor of the trial.
Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
To be included in the study you MUST have:
and
Exclusion Criteria:
To be included in the study you MUST NOT have:
You must not have taken or have had the following types of treatment or therapy prior to being admitted into the study:
If you have had any of the above, you may still qualify for the study following a washout period (time for your body to completely eliminate, or get rid of, the medication). The study doctor will evaluate whether there is anything else in your history that may affect your safety in the study or interfere with evaluations. He/she may therefore advise you not to participate.
Contacts and Locations
More Information
| Responsible Party: | Intendis Inc. ( Therapeutic Area Head ) |
| Study ID Numbers: | 90905, 304343 (90905), 306100 (91138), 4343 |
| Study First Received: | February 21, 2002 |
| Last Updated: | September 30, 2009 |
| ClinicalTrials.gov Identifier: | NCT00031096 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Acne Vulgaris Propionibacterium acnes |
|
Azelaic acid Facial Dermatoses Skin Diseases Antineoplastic Agents Acneiform Eruptions |
Therapeutic Uses Sebaceous Gland Diseases Dermatologic Agents Pharmacologic Actions Acne Vulgaris |