Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00145106
Status:
COMPLETED
Last Update Posted:
2005-12-15
First Post:
2005-09-01
Brief Title:
Comparison of Tazarotene and Minocycline Therapies for Maintenance of Facial Acne Vulgaris
Sponsor:
KGL Inc
Organization:
KGL Inc
Study Overview
Official Title:
Regimen of Tazorac 1 Gel Minocycline Cap in Tx of Individuals wAcne Vulgaris Effects of Maintenance Therapy on Duration of Improvement of Tazorac 1 Gel Used in Conjunction wPlacebo Cap Compared wMinocycline Cap Used in Conjunction wEither Tazorac 1 Gel or Vehicle Gel
Status:
COMPLETED
Status Verified Date:
2005-09
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:
The purpose of the study is to compare the efficacy of three maintenance regimens topical tazarotene oral minocycline or both in sustaining improvement in acne
Detailed Description:
For many years antibiotic therapy has been the backbone of therapy for inflammatory acne However topical retinoids also offer efficacy against inflammatory acne and the combination of a topical retinoid and an antibiotic can result in faster and more complete clearing of inflammatory lesions than either drug alone
The reduced sensitivity of Propionibacterium acnes to antibiotics is a growing problem Resistance is a major issue not only because it can result in treatment failure but also because of concerns that it may potentially be transferred to other bacteria that anti-acne antibiotics are used used against One of the most important factors predisposing to the development of resistant strains of propionibacterium acnes is the prolonged use of antibiotics Therefore in order to help minimize the development for such resistance it is evident that maintenance strategies for acne should aim to minimize the long-term use of antibiotics
Topical retinoids are a rational choice for maintenance therapy due to their activity on microcomedones the precursor for all acne lesions Nevertheless there is a paucity of data evaluating this use in a maintenance setting The aim of this study was to determine whether patients with moderate to severe inflammatory acne who have achieved a good level of clearance eg 75 can maintain the improvement in their acne using maintenance therapy THe study compared the efficacy of three maintenance therapies topical tazarotene oral minocycline and topical tazarotene plus oral minocycline in sustaining the clinical improvement attained after initial topical tazarotene plus oral minocycline therapy
The reduced sensitivity of Propionibacterium acnes to antibiotics is a growing problem Resistance is a major issue not only because it can result in treatment failure but also because of concerns that it may potentially be transferred to other bacteria that anti-acne antibiotics are used used against One of the most important factors predisposing to the development of resistant strains of propionibacterium acnes is the prolonged use of antibiotics Therefore in order to help minimize the development for such resistance it is evident that maintenance strategies for acne should aim to minimize the long-term use of antibiotics
Topical retinoids are a rational choice for maintenance therapy due to their activity on microcomedones the precursor for all acne lesions Nevertheless there is a paucity of data evaluating this use in a maintenance setting The aim of this study was to determine whether patients with moderate to severe inflammatory acne who have achieved a good level of clearance eg 75 can maintain the improvement in their acne using maintenance therapy THe study compared the efficacy of three maintenance therapies topical tazarotene oral minocycline and topical tazarotene plus oral minocycline in sustaining the clinical improvement attained after initial topical tazarotene plus oral minocycline therapy
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