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

GBI Research, January 2012, Pages: 99

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.

1 Table of Contents
1.1 List of Tables
1.2 List of Figures

2 Introduction
2.1 GBI Research Report Guidance

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

4 Endpoints - Clinical Trials in Dermatology - Marketed and Pipeline Products Assessment
4.1 Alopecia
4.1.1 Primary Endpoints in Alopecia
4.1.2 Secondary Endpoints in Alopecia
4.1.3 Major Marketed Drugs - Safety and Efficacy Analysis
4.1.4 Phase III Molecules Analysis
4.1.5 Most Promising Drugs' Profiles
4.1.6 Phase II Molecules Analysis
4.1.7 Terminated Trials
4.2 Candidiasis
4.2.1 Primary Endpoints in Candidiasis
4.2.2 Secondary Endpoints in Candidiasis
4.2.3 Major Marketed Drugs (Azole Group) - Safety and Efficacy Analysis
4.2.4 Major Marketed Drugs (Echinocandins Class) - Safety and Efficacy Analysis
4.2.5 Major Marketed Drugs (Polyene class) - Safety and Efficacy Analysis
4.2.6 Phase III Molecules Analysis
4.2.7 Most Promising Drugs' Profiles
4.2.8 Phase II Molecules Analysis
4.2.9 Terminated Trials
4.3 Atopic Dermatitis
4.3.1 Primary Endpoints in Atopic Dermatitis
4.3.2 Secondary Endpoints in Atopic Dermatitis
4.3.3 Major Marketed Drugs - Safety and Efficacy Analysis
4.3.4 Phase III Molecules Analysis
4.3.5 Most Promising Drugs' Profiles
4.3.6 Phase II Molecules Analysis
4.3.7 Terminated Trials
4.4 Herpes Zoster
4.4.1 Primary Endpoints in Herpes Zoster
4.4.2 Secondary Endpoints in Herpes Zoster
4.4.3 Major Marketed Drugs - Safety and Efficacy Analysis
4.4.4 Phase III Molecules Analysis
4.4.5 Most Promising Drugs' Profiles
4.4.6 Phase II Molecules Analysis
4.4.7 Terminated Trials
4.5 Acne Vulgaris
4.5.1 Primary Endpoints in Acne Vulgaris
4.5.2 Secondary Endpoints in Acne Vulgaris
4.5.3 Major Marketed Drugs - Safety and Efficacy Analysis
4.5.4 Phase III Molecules Analysis
4.5.5 Most Promising Drugs' Profiles
4.5.6 Phase II Molecules Analysis
4.5.7 Terminated Trials

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

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

1.1 List of Tables
Table 1: Endpoints - Clinical Trials in Dermatology, Alopecia, Primary and Secondary Endpoints of Phase III Molecules , Global, 2010
Table 2: Endpoints - Clinical Trials in Dermatology, Alopecia, Primary and Secondary Endpoints of Phase II Molecules, Global, 2010
Table 3: Endpoints - Clinical Trials in Dermatology, Alopecia, Primary and Secondary Endpoints of Discontinued Molecules, Global, 2010
Table 4: Endpoints - Clinical Trials in Dermatology, Candidiasis, Primary and Secondary Endpoints of Phase III Molecules , Global, 2010
Table 5: Endpoints - Clinical Trials in Dermatology, Candidiasis, Primary and Secondary Endpoints of Phase II Molecules , Global, 2010
Table 6: Endpoints - Clinical Trials in Dermatology, Candidiasis, Primary and Secondary Endpoints of Discontinued Molecules, Global, 2010
Table 7: Endpoints - Clinical Trials in Dermatology, Atopic Dermatitis, Primary and Secondary Endpoints of Phase III Molecules , Global, 2010
Table 8: Endpoints - Clinical Trials in Dermatology, Atopic Dermatitis, Primary and Secondary Endpoints of Phase II Molecules, Global, 2010
Table 9: Endpoints - Clinical Trials in Dermatology, Atopic Dermatitis, Primary and Secondary Endpoints of Discontinued Molecules, Global, 2010
Table 10: Endpoints - Clinical Trials in Dermatology, Herpes Zoster, Primary and Secondary Endpoints of Phase III Molecules , Global, 2010
Table 11: Endpoints - Clinical Trials in Dermatology, Herpes Zoster, Primary and Secondary Endpoints of Phase II Molecules, Global, 2010
Table 12: Endpoints - Clinical Trials in Dermatology, Herpes Zoster, Primary and Secondary Endpoints of Discontinued Molecules, Global, 2010
Table 13: Endpoints - Clinical Trials in Dermatology, Acne Vulgaris, Primary and Secondary Endpoints of Phase III Molecules, Global, 2010
Table 14: Endpoints - Clinical Trials in Dermatology, Acne Vulgaris, Primary and Secondary Endpoints of Phase II Molecules, Global, 2010
Table 15: Endpoints - Clinical Trials in Dermatology, Acne Vulgaris, Primary and Secondary Endpoints of Discontinued Molecules, Global, 2010

1.2 List of Figures
Figure 1: Endpoints - Clinical Trials in Dermatology, Alopecia, Phase III Clinical Trials by Primary Endpoints, Global, 2010
Figure 2: Endpoints - Clinical Trials in Dermatology, Alopecia, Phase III Clinical Trials by Multiple Primary Endpoints, Global, 2010
Figure 3: Endpoints - Clinical Trials in Dermatology, Alopecia, Phase III Clinical Trials by Secondary Endpoints, Global, 2010
Figure 4: Endpoints - Clinical Trials in Dermatology, Alopecia, Phase III Clinical Trials by Multiple Secondary Endpoints, Global, 2010
Figure 5: Endpoints - Clinical Trials in Dermatology, Alopecia, Phase II Clinical Trials by Multiple Primary Endpoints, Global, 2010
Figure 6: Endpoints - Clinical Trials in Dermatology, Alopecia, Phase II Clinical Trials by Multiple Secondary Endpoints, Global, 2010
Figure 7: Endpoints - Clinical Trials in Dermatology, Candidiasis, Phase III Clinical Trials by Primary Endpoints, Global, 2010
Figure 8: Endpoints - Clinical Trials in Dermatology, Candidiasis, Phase III Clinical Trials by Multiple Primary Endpoints, Global, 2010
Figure 9: Endpoints - Clinical Trials in Dermatology, Candidiasis, Phase III Clinical Trials by Secondary Endpoints, Global, 2010
Figure 10: Endpoints - Clinical Trials in Dermatology, Candidiasis, Phase III Clinical Trials by Multiple Secondary Endpoints, Global, 2010
Figure 11: Endpoints - Clinical Trials in Dermatology, Candidiasis, Phase II Clinical Trials by Primary Endpoints, Global, 2010
Figure 12: Endpoints - Clinical Trials in Dermatology, Candidiasis, Phase II Clinical Trials by Secondary Endpoints, Global, 2010
Figure 13: Endpoints - Clinical Trials in Dermatology, Candidiasis, Phase II Clinical Trials by Multiple Secondary Endpoints, Global, 2010
Figure 14: Endpoints - Clinical Trials in Dermatology, Atopic Dermatitis, Phase III Clinical Trials by Primary Endpoints, Global, 2010
Figure 15: Endpoints - Clinical Trials in Dermatology, Atopic Dermatitis, Phase III Clinical Trials by Multiple Primary Endpoints, Global, 2010
Figure 16: Endpoints - Clinical Trials in Dermatology, Atopic Dermatitis, Phase III Clinical Trials by Secondary Endpoints, Global, 2010
Figure 17: Endpoints - Clinical Trials in Dermatology, Atopic Dermatitis, Phase III Clinical Trials by Multiple Secondary Endpoints, Global, 2010
Figure 18: Endpoints - Clinical Trials in Dermatology, Atopic Dermatitis, Phase II Clinical Trials by Primary Endpoints, Global, 2010
Figure 19: Endpoints - Clinical Trials in Dermatology, Atopic Dermatitis, Phase II Clinical Trials by Multiple Primary Endpoints, Global, 2010
Figure 20: Endpoints - Clinical Trials in Dermatology, Atopic Dermatitis, Phase II Clinical Trials by Secondary Endpoints, Global, 2010
Figure 21: Endpoints - Clinical Trials in Dermatology, Atopic Dermatitis, Phase II Clinical Trials by Multiple Secondary Endpoints, Global, 2010
Figure 22: Endpoints - Clinical Trials in Dermatology, Herpes Zoster, Phase III Clinical Trials by Primary Endpoints, Global, 2010
Figure 23: Endpoints - Clinical Trials in Dermatology, Herpes Zoster, Phase III Clinical Trials by Multiple Primary Endpoints, Global, 2010
Figure 24: Endpoints - Clinical Trials in Dermatology, Herpes Zoster, Phase III Clinical Trials by Secondary Endpoints, Global, 2010
Figure 25: Endpoints - Clinical Trials in Dermatology, Herpes Zoster, Phase III Clinical Trials by Multiple Secondary Endpoints, Global, 2010
Figure 26: Endpoints - Clinical Trials in Dermatology, Herpes Zoster, Phase II Clinical Trials by Primary Endpoints, Global, 2010
Figure 27: Endpoints - Clinical Trials in Dermatology, Herpes Zoster, Phase II Clinical Trials by Multiple Primary Endpoints, Global, 2010
Figure 28: Endpoints - Clinical Trials in Dermatology, Herpes Zoster, Phase II Clinical Trials by Secondary Endpoints, Global, 2010
Figure 29: Endpoints - Clinical Trials in Dermatology, Herpes Zoster, Phase II Clinical Trials by Multiple Secondary Endpoints, Global, 2010
Figure 30: Endpoints - Clinical Trials in Dermatology, Acne Vulgaris, Phase III Clinical Trials by Primary Endpoints, Global, 2010
Figure 31: Endpoints - Clinical Trials in Dermatology, Acne Vulgaris, Phase III Clinical Trials by Multiple Primary Endpoints, Global, 2010
Figure 32: Endpoints - Clinical Trials in Dermatology, Acne Vulgaris, Phase III Clinical Trials by Secondary Endpoints, Global, 2010
Figure 33: Endpoints - Clinical Trials in Dermatology, Acne Vulgaris, Phase III Clinical Trials by Multiple Secondary Endpoints, Global, 2010
Figure 34: Endpoints - Clinical Trials in Dermatology, Acne Vulgaris, Phase II Clinical Trials by Primary Endpoints, Global, 2010
Figure 35: Endpoints - Clinical Trials in Dermatology, Acne Vulgaris, Phase II Clinical Trials by Multiple Primary Endpoints, Global, 2010
Figure 36: Endpoints - Clinical Trials in Dermatology, Acne Vulgaris, Phase II Clinical Trials by Secondary Endpoints, Global, 2010
Figure 37: Endpoints - Clinical Trials in Dermatology, Acne Vulgaris, Phase II Clinical Trials by Multiple Secondary Endpoints, Global, 2010

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.

Safety - The Primary Endpoint in the Majority of the Clinical Trials in Dermatology

Safety is the most important endpoint in drawing conclusions on the results of a clinical trial in dermatology. Adverse events are an important safety issue in clinical trials. The adverse events associated with a drug have to be determined in terms of their frequency, severity and the time when they occur after randomization across a group of patients compared to another group. The approval system established by the Food, Drug and Cosmetics Act of 1938, required all drugs to be approved for safety by the Food and Drug Administration (FDA); failing which the trial would be discontinued/terminated and many valuable drugs would not enter the market.

Secondary Endpoints are Widely Used in the Clinical Trials of Major Dermatological Disorders

The classification of the five major dermatological disorders is based upon the number of pipeline molecules present in Phase III stage of development. Safety is the most commonly used secondary endpoint in clinical trials of AD followed by the Change in non-inflammatory lesions count which is most widely used in clinical trials of acne vulgaris. The Varicella Zoster Virus (VZV) antibody response, Clinical response and Hair growth are secondary endpoints which are most widely used in clinical trials of HZ, candidiasis and alopecia respectively.

Inflammatory Lesions Count - An Endpoint Used in Clinical Trials of Most of the Marketed Drugs in Acne Vulgaris

The major marketed drugs used to treat acne vulgaris are Solodyn, Doryx, Epiduo, Duac, Tazorac, Ziana, Differin and Benzaclin. The endpoint used in clinical trials of Solodyn, Epiduo, Duac, Tazorac, Ziana, Differin and Benzaclin was mean/absolute/percentage change in inflammatory lesions count. This was used as a major endpoint in most of the clinical trials of acne vulgaris. The inflammatory lesions count includes nodules, papules and pustules. The change in inflammatory lesions count is measured by Investigator's Global Assessment (IGA) score. Success is defined as decrease in IGA score by at least 2 grades from the baseline score.

- Merck
- Novartis
- GlaxoSmithKline
- Pfizer
- Astellas Pharma
- Galderma

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