Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00031096
Status:
COMPLETED
Last Update Posted:
2023-06-09
First Post:
2002-02-21
Brief Title:
Comparison of Efficacy and Safety of Azelaic Acid 15 Gel With Its Vehicle in Subjects With Mild to Moderate Acne
Sponsor:
LEO Pharma
Organization:
LEO Pharma
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2014-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 doctors office for up to 5 visits
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 doctors office for up to 5 visits
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 4343 | OTHER | Company internal | None |
| 304343 90905 | OTHER | None | None |
| 306100 91138 | OTHER | None | None |