Endpoints - Clinical Trials in Dermatology - Inflammatory Lesions Count is the Key Determinant of Success in Acne Vulgaris Clinical Trials

Report Summary

GBI Research, the leading business intelligence provider, has released its latest research ‘Endpoints - Clinical Trials in Dermatology - Inflammatory Lesions Count is the Key Determinant of Success in Acne Vulgaris Clinical Trials’ which provides an insight into different endpoints that are used in dermatological clinical trials. The report examines different aspects under clinical trial endpoints in dermatology such as analysis on major marketed drugs with an emphasis on safety and efficacy details, Phase II and Phase III clinical trial analysis for both completed and ongoing clinical trials, most promising drugs with more emphasis on safety, efficacy and clinical trial details, and terminated trial analysis. The company profiling highlights the marketed drugs in dermatology of different companies.

Dermatological disorders are diverse in clinical presentation, severity and epidemiology; and it affects all age groups of both sexes, however; children are more vulnerable and have been studied worldwide. This report details ‘Endpoints- Clinical Trials in Dermatology’, highlighting the five major dermatological disorders which are Alopecia, Acne Vulgaris, Herpes Zoster, Candidiasis and Atopic Dermatitis. The classification of the five major dermatological disorders is based upon the number of pipeline molecules present in Phase III stage of development. GBI Research analyses that safety and efficacy is the most widely used endpoint in majority of the clinical trials in dermatology. The primary and secondary endpoint that is mainly used to assess the majority of trial outcomes is safety.

Scope

• Data and analysis on the marketed products and analysis of their efficacy and safety details.
• Analysis of the five major dermatological disorders which include Alopecia, Acne Vulgaris, Herpes Zoster, Candidiasis and Atopic Dermatitis.
• Analysis of the Phase III and Phase II clinical trials in terms of percentage cases. Also analysis of terminated trials is included in this chapter. Only industry sponsored studies are included in the report.
• Analysis on most promising molecules of five major dermatological disorders with emphasis on their efficacy and safety details.
• Company profiling talks in detail about the companies, which are strong in the market.

Reasons to buy

• Build effective strategies to launch their pipeline products by identifying potential geographies.
• Exploit in-licensing and out-licensing opportunities by identifying products that might probably fill their portfolio gaps.
• Align your product portfolio to the markets with high growth potential.
• Develop market-entry and market expansion strategies by identifying the leading therapeutic segments and geographic markets poised for strong growth.
• Reinforce R&D pipelines by identifying new target mechanisms which can produce first-in-class molecules with increased efficiency and better safety profiles.
• Develop key strategic initiatives by understanding the key focus areas of leading companies.

Table of Contents

1 Table of Contents 3
1.1 List of Tables 5
1.2 List of Figures 6

2 Introduction 8
2.1 GBI Research Report Guidance 8

3 Endpoints - Clinical Trials in Dermatology - Overview 9
3.1 Endpoints Used for Regular Approval 9
3.1.1 Safety and Efficacy 9
3.1.2 Change in Inflammatory Lesion Counts 9
3.1.3 Varicella Zoster Virus (VZV) Antibody Response 9
3.1.4 Pain 9

4 Endpoints - Clinical Trials in Dermatology - Marketed and Pipeline Products Assessment 10
4.1 Alopecia 10
4.1.1 Primary Endpoints in Alopecia 10
4.1.2 Secondary Endpoints in Alopecia 10
4.1.3 Major Marketed Drugs - Safety and Efficacy Analysis 11
4.1.4 Phase III Molecules Analysis 14
4.1.5 Most Promising Drugs’ Profiles 16
4.1.6 Phase II Molecules Analysis 17
4.1.7 Terminated Trials 19
4.2 Candidiasis 19
4.2.1 Primary Endpoints in Candidiasis 19
4.2.2 Secondary Endpoints in Candidiasis 20
4.2.3 Major Marketed Drugs (Azole Group) - Safety and Efficacy Analysis 21
4.2.4 Major Marketed Drugs (Echinocandins Class) - Safety and Efficacy Analysis 25
4.2.5 Major Marketed Drugs (Polyene class) - Safety and Efficacy Analysis 27
4.2.6 Phase III Molecules Analysis 28
4.2.7 Most Promising Drugs’ Profiles 32
4.2.8 Phase II Molecules Analysis 34
4.2.9 Terminated Trials 36
4.3 Atopic Dermatitis 37
4.3.1 Primary Endpoints in Atopic Dermatitis 37
4.3.2 Secondary Endpoints in Atopic Dermatitis 37
4.3.3 Major Marketed Drugs - Safety and Efficacy Analysis 38
4.3.4 Phase III Molecules Analysis 42
4.3.5 Most Promising Drugs’ Profiles 47
4.3.6 Phase II Molecules Analysis 48
4.3.7 Terminated Trials 54
4.4 Herpes Zoster 54
4.4.1 Primary Endpoints in Herpes Zoster 54
4.4.2 Secondary Endpoints in Herpes Zoster 55
4.4.3 Major Marketed Drugs - Safety and Efficacy Analysis 55
4.4.4 Phase III Molecules Analysis 58
4.4.5 Most Promising Drugs’ Profiles 62
4.4.6 Phase II Molecules Analysis 64
4.4.7 Terminated Trials 68
4.5 Acne Vulgaris 69
4.5.1 Primary Endpoints in Acne Vulgaris 69
4.5.2 Secondary Endpoints in Acne Vulgaris 70
4.5.3 Major Marketed Drugs - Safety and Efficacy Analysis 70
4.5.4 Phase III Molecules Analysis 77
4.5.5 Most Promising Drugs’ Profiles 83
4.5.6 Phase II Molecules Analysis 84
4.5.7 Terminated Trials 89

5 Endpoints - Clinical Trials in Dermatology - Company Profiles 90
5.1 Merck 90
5.1.1 Business Description 90
5.1.2 Product Portfolio 90
5.2 Novartis 91
5.2.1 Business Description 91
5.2.2 Product Portfolio 91
5.3 GlaxoSmithKline 92
5.3.1 Business Description 92
5.3.2 Product Portfolio 92
5.4 Pfizer 93
5.4.1 Business Description 93
5.4.2 Product Portfolio 93
5.5 Astellas Pharma 93
5.5.1 Business Description 93
5.5.2 Product Portfolio 94
5.6 Galderma 94
5.6.1 Business Description 94
5.6.2 Product Portfolio 94

6 Endpoints - Clinical Trials in Dermatology - Appendix 95
6.1 Market Definitions 95
6.2 Abbreviations 95
6.3 Research Methodology 97
6.3.1 Major Dermatological Disorders and their Product Profiling 97
6.3.2 Marketed and Pipeline Products Assessment 98
6.3.3 Company Profiles 98
6.4 Contact Us 98
6.5 Disclaimer 99
6.6 Sources 99

List of Tables

Table 1: Endpoints - Clinical Trials in Dermatology, Alopecia, Primary and Secondary Endpoints of Phase III Molecules , Global, 2010 16
Table 2: Endpoints - Clinical Trials in Dermatology, Alopecia, Primary and Secondary Endpoints of Phase II Molecules, Global, 2010 18
Table 3: Endpoints - Clinical Trials in Dermatology, Alopecia, Primary and Secondary Endpoints of Discontinued Molecules, Global, 2010 19
Table 4: Endpoints - Clinical Trials in Dermatology, Candidiasis, Primary and Secondary Endpoints of Phase III Molecules , Global, 2010 31
Table 5: Endpoints - Clinical Trials in Dermatology, Candidiasis, Primary and Secondary Endpoints of Phase II Molecules , Global, 2010 36
Table 6: Endpoints - Clinical Trials in Dermatology, Candidiasis, Primary and Secondary Endpoints of Discontinued Molecules, Global, 2010 36
Table 7: Endpoints - Clinical Trials in Dermatology, Atopic Dermatitis, Primary and Secondary Endpoints of Phase III Molecules , Global, 2010 45
Table 8: Endpoints - Clinical Trials in Dermatology, Atopic Dermatitis, Primary and Secondary Endpoints of Phase II Molecules, Global, 2010 52
Table 9: Endpoints - Clinical Trials in Dermatology, Atopic Dermatitis, Primary and Secondary Endpoints of Discontinued Molecules, Global, 2010 54
Table 10: Endpoints - Clinical Trials in Dermatology, Herpes Zoster, Primary and Secondary Endpoints of Phase III Molecules , Global, 2010 61
Table 11: Endpoints - Clinical Trials in Dermatology, Herpes Zoster, Primary and Secondary Endpoints of Phase II Molecules, Global, 2010 68
Table 12: Endpoints - Clinical Trials in Dermatology, Herpes Zoster, Primary and Secondary Endpoints of Discontinued Molecules, Global, 2010 68
Table 13: Endpoints - Clinical Trials in Dermatology, Acne Vulgaris, Primary and Secondary Endpoints of Phase III Molecules, Global, 2010 81
Table 14: Endpoints - Clinical Trials in Dermatology, Acne Vulgaris, Primary and Secondary Endpoints of Phase II Molecules, Global, 2010 88
Table 15: Endpoints - Clinical Trials in Dermatology, Acne Vulgaris, Primary and Secondary Endpoints of Discontinued Molecules, Global, 2010 89

List of Figures

Figure 1: Endpoints - Clinical Trials in Dermatology, Alopecia, Phase III Clinical Trials by Primary Endpoints, Global, 2010 14
Figure 2: Endpoints - Clinical Trials in Dermatology, Alopecia, Phase III Clinical Trials by Multiple Primary Endpoints, Global, 2010 14
Figure 3: Endpoints - Clinical Trials in Dermatology, Alopecia, Phase III Clinical Trials by Secondary Endpoints, Global, 2010 15
Figure 4: Endpoints - Clinical Trials in Dermatology, Alopecia, Phase III Clinical Trials by Multiple Secondary Endpoints, Global, 2010 15
Figure 5: Endpoints - Clinical Trials in Dermatology, Alopecia, Phase II Clinical Trials by Multiple Primary Endpoints, Global, 2010 17
Figure 6: Endpoints - Clinical Trials in Dermatology, Alopecia, Phase II Clinical Trials by Multiple Secondary Endpoints, Global, 2010 18
Figure 7: Endpoints - Clinical Trials in Dermatology, Candidiasis, Phase III Clinical Trials by Primary Endpoints, Global, 2010 28
Figure 8: Endpoints - Clinical Trials in Dermatology, Candidiasis, Phase III Clinical Trials by Multiple Primary Endpoints, Global, 2010 28
Figure 9: Endpoints - Clinical Trials in Dermatology, Candidiasis, Phase III Clinical Trials by Secondary Endpoints, Global, 2010 29
Figure 10: Endpoints - Clinical Trials in Dermatology, Candidiasis, Phase III Clinical Trials by Multiple Secondary Endpoints, Global, 2010 30
Figure 11: Endpoints - Clinical Trials in Dermatology, Candidiasis, Phase II Clinical Trials by Primary Endpoints, Global, 2010 34
Figure 12: Endpoints - Clinical Trials in Dermatology, Candidiasis, Phase II Clinical Trials by Secondary Endpoints, Global, 2010 34
Figure 13: Endpoints - Clinical Trials in Dermatology, Candidiasis, Phase II Clinical Trials by Multiple Secondary Endpoints, Global, 2010 35
Figure 14: Endpoints - Clinical Trials in Dermatology, Atopic Dermatitis, Phase III Clinical Trials by Primary Endpoints, Global, 2010 42
Figure 15: Endpoints - Clinical Trials in Dermatology, Atopic Dermatitis, Phase III Clinical Trials by Multiple Primary Endpoints, Global, 2010 43
Figure 16: Endpoints - Clinical Trials in Dermatology, Atopic Dermatitis, Phase III Clinical Trials by Secondary Endpoints, Global, 2010 43
Figure 17: Endpoints - Clinical Trials in Dermatology, Atopic Dermatitis, Phase III Clinical Trials by Multiple Secondary Endpoints, Global, 2010 44
Figure 18: Endpoints - Clinical Trials in Dermatology, Atopic Dermatitis, Phase II Clinical Trials by Primary Endpoints, Global, 2010 48
Figure 19: Endpoints - Clinical Trials in Dermatology, Atopic Dermatitis, Phase II Clinical Trials by Multiple Primary Endpoints, Global, 2010 49
Figure 20: Endpoints - Clinical Trials in Dermatology, Atopic Dermatitis, Phase II Clinical Trials by Secondary Endpoints, Global, 2010 50
Figure 21: Endpoints - Clinical Trials in Dermatology, Atopic Dermatitis, Phase II Clinical Trials by Multiple Secondary Endpoints, Global, 2010 51
Figure 22: Endpoints - Clinical Trials in Dermatology, Herpes Zoster, Phase III Clinical Trials by Primary Endpoints, Global, 2010 58
Figure 23: Endpoints - Clinical Trials in Dermatology, Herpes Zoster, Phase III Clinical Trials by Multiple Primary Endpoints, Global, 2010 59
Figure 24: Endpoints - Clinical Trials in Dermatology, Herpes Zoster, Phase III Clinical Trials by Secondary Endpoints, Global, 2010 60
Figure 25: Endpoints - Clinical Trials in Dermatology, Herpes Zoster, Phase III Clinical Trials by Multiple Secondary Endpoints, Global, 2010 60
Figure 26: Endpoints - Clinical Trials in Dermatology, Herpes Zoster, Phase II Clinical Trials by Primary Endpoints, Global, 2010 64
Figure 27: Endpoints - Clinical Trials in Dermatology, Herpes Zoster, Phase II Clinical Trials by Multiple Primary Endpoints, Global, 2010 65
Figure 28: Endpoints - Clinical Trials in Dermatology, Herpes Zoster, Phase II Clinical Trials by Secondary Endpoints, Global, 2010 66
Figure 29: Endpoints - Clinical Trials in Dermatology, Herpes Zoster, Phase II Clinical Trials by Multiple Secondary Endpoints, Global, 2010 67
Figure 30: Endpoints - Clinical Trials in Dermatology, Acne Vulgaris, Phase III Clinical Trials by Primary Endpoints, Global, 2010 77
Figure 31: Endpoints - Clinical Trials in Dermatology, Acne Vulgaris, Phase III Clinical Trials by Multiple Primary Endpoints, Global, 2010 78
Figure 32: Endpoints - Clinical Trials in Dermatology, Acne Vulgaris, Phase III Clinical Trials by Secondary Endpoints, Global, 2010 79
Figure 33: Endpoints - Clinical Trials in Dermatology, Acne Vulgaris, Phase III Clinical Trials by Multiple Secondary Endpoints, Global, 2010 80
Figure 34: Endpoints - Clinical Trials in Dermatology, Acne Vulgaris, Phase II Clinical Trials by Primary Endpoints, Global, 2010 84
Figure 35: Endpoints - Clinical Trials in Dermatology, Acne Vulgaris, Phase II Clinical Trials by Multiple Primary Endpoints, Global, 2010 85
Figure 36: Endpoints - Clinical Trials in Dermatology, Acne Vulgaris, Phase II Clinical Trials by Secondary Endpoints, Global, 2010 86
Figure 37: Endpoints - Clinical Trials in Dermatology, Acne Vulgaris, Phase II Clinical Trials by Multiple Secondary Endpoints, Global, 2010 87"