CLINICAL TRIALS PROFILE FOR DAPSONE

All Clinical Trials for Dapsone

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000596 ↗	Diffuse Fibrotic Lung Disease	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 2	1978-06-01	To determine the effects of cyclophosphamide compared with prednisone, dapsone, or high-dose intermittent 'pulse' therapy with methylprednisolone in patients with idiopathic pulmonary fibrosis. Also, to evaluate the use of intermittent, short-term, high-dose intravenous corticosteroids in patients with sarcoidosis. There were actually four separate clinical trials.
NCT00000640 ↗	A Phase III Comparative Study of Dapsone / Trimethoprim and Clindamycin / Primaquine Versus Sulfamethoxazole / Trimethoprim in the Treatment of Mild-to-Moderate PCP in Patients With AIDS	Completed	Glaxo Wellcome	Phase 3	1969-12-31	To evaluate the effectiveness of two oral treatments for mild to moderate Pneumocystis carinii pneumonia (PCP): dapsone/trimethoprim or clindamycin/primaquine as compared to a standard treatment program of sulfamethoxazole/trimethoprim (SMX/TMP) to assess the tolerance of these two alternative treatments as compared to the standard treatment of SMX/TMP. Per 09/09/92 amendment, to assess the efficacy and tolerance of these two alternative treatments in patients who are intolerant to SMX/TMP. The type of treatment being studied has the advantages of wide applicability throughout the world (including developing countries) and low cost. An oral treatment is more accessible to patients than drugs given by injection or by inhalation.
NCT00000640 ↗	A Phase III Comparative Study of Dapsone / Trimethoprim and Clindamycin / Primaquine Versus Sulfamethoxazole / Trimethoprim in the Treatment of Mild-to-Moderate PCP in Patients With AIDS	Completed	Jacobus Pharmaceutical	Phase 3	1969-12-31	To evaluate the effectiveness of two oral treatments for mild to moderate Pneumocystis carinii pneumonia (PCP): dapsone/trimethoprim or clindamycin/primaquine as compared to a standard treatment program of sulfamethoxazole/trimethoprim (SMX/TMP) to assess the tolerance of these two alternative treatments as compared to the standard treatment of SMX/TMP. Per 09/09/92 amendment, to assess the efficacy and tolerance of these two alternative treatments in patients who are intolerant to SMX/TMP. The type of treatment being studied has the advantages of wide applicability throughout the world (including developing countries) and low cost. An oral treatment is more accessible to patients than drugs given by injection or by inhalation.
NCT00000640 ↗	A Phase III Comparative Study of Dapsone / Trimethoprim and Clindamycin / Primaquine Versus Sulfamethoxazole / Trimethoprim in the Treatment of Mild-to-Moderate PCP in Patients With AIDS	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 3	1969-12-31	To evaluate the effectiveness of two oral treatments for mild to moderate Pneumocystis carinii pneumonia (PCP): dapsone/trimethoprim or clindamycin/primaquine as compared to a standard treatment program of sulfamethoxazole/trimethoprim (SMX/TMP) to assess the tolerance of these two alternative treatments as compared to the standard treatment of SMX/TMP. Per 09/09/92 amendment, to assess the efficacy and tolerance of these two alternative treatments in patients who are intolerant to SMX/TMP. The type of treatment being studied has the advantages of wide applicability throughout the world (including developing countries) and low cost. An oral treatment is more accessible to patients than drugs given by injection or by inhalation.

Clinical Trial Conditions for Dapsone

Condition Name

Condition Name for Dapsone
Intervention	Trials
Acne Vulgaris	21
Malaria	13
HIV Infections	11
Pneumonia, Pneumocystis Carinii	8

Condition MeSH

Condition MeSH for Dapsone
Intervention	Trials
Acne Vulgaris	22
Malaria	17
HIV Infections	11
Pneumonia, Pneumocystis	9

Clinical Trial Locations for Dapsone

Trials by Country

Trials by Country for Dapsone
Location	Trials
United States	225
Malawi	8
Tanzania	7
Canada	7
Burkina Faso	3

Trials by US State

Trials by US State for Dapsone
Location	Trials
California	21
Pennsylvania	15
New York	15
Florida	11
North Carolina	11

Clinical Trial Progress for Dapsone

Clinical Trial Phase

Clinical Trial Phase for Dapsone
Clinical Trial Phase	Trials
Phase 4	22
Phase 3	25
Phase 2/Phase 3	3

Clinical Trial Status

Clinical Trial Status for Dapsone
Clinical Trial Phase	Trials
Completed	60
Unknown status	7
Recruiting	7

Clinical Trial Sponsors for Dapsone

Sponsor Name

Sponsor Name for Dapsone
Sponsor	Trials
Allergan	23
National Institute of Allergy and Infectious Diseases (NIAID)	9
Jacobus Pharmaceutical	7

Sponsor Type

Sponsor Type for Dapsone
Sponsor	Trials
Other	117
Industry	61
NIH	15

Dapsone: Clinical Trials, Market Analysis, and Projections

Introduction

Dapsone, a versatile antibiotic with immunomodulatory properties, has been used in various medical applications, including the treatment of leprosy, dermatitis herpetiformis, and acne. This article provides an update on recent clinical trials, market analysis, and projections for dapsone.

Clinical Trials Update

Dapsone in Immune Thrombocytopenia (ITP)

A recent prospective multicenter randomized open-label controlled trial, DAPS-ITP, assessed the efficacy and safety of dapsone as a second-line treatment for adult patients with primary immune thrombocytopenia (ITP)[1].

• Patient Profile: The trial included 93 patients with primary ITP, who had previously responded transiently to corticosteroids and/or intravenous immunoglobulin (IVIg) and had a platelet count of ≤30 x 10^9/L or <50 x 10^9/L with bleeding manifestations.
• Treatment Arms: Patients were randomized to receive either dapsone at 100 mg/day in combination with prednisone for 3 weeks (arm A) or just the 3-week course of prednisone (arm B).
• Outcomes: The overall response rate (ORR) at week 52 was 8.70% in arm A and 4.26% in arm B, with no significant difference between the two arms. However, the trial highlighted a high rate of early discontinuation of dapsone due to adverse drug reactions (ADRs), such as anemia, gastrointestinal manifestations, high methemoglobinemia, and toxidermia.
• Real-World Evidence: A single-arm, emulated trial using the CARMEN-France registry supported these findings, showing an ORR of 10.6% at week 52 and 20.0% at week 24, with similar ADR profiles.

Dapsone in Acne Treatment

Dapsone has also been evaluated for its efficacy in treating acne vulgaris. The FDA approved ACZONE® (dapsone) gel, 5% in 2005, and more recently, trials have been conducted for ACZONE® gel, 7.5%[4].

• Trial Design: Two Phase 3 trials (Trials 006 and 007) were conducted, enrolling approximately 2180 subjects each, who applied ACZONE® gel, 7.5% or vehicle gel once daily for 12 weeks.
• Outcomes: The results showed that ACZONE® gel, 7.5% was statistically superior to vehicle gel in all co-primary efficacy endpoints, including the proportion of subjects achieving a Global Acne Assessment Score (GAAS) of 0 or 1 and the absolute change in inflammatory lesion counts.

Market Analysis

Market Size and Growth

The global dapsone market has been growing steadily, driven by various factors:

• Current Market Size: The dapsone market was valued at USD 436.76 million in 2021[5].
• Projected Growth: It is expected to reach USD 687.77 million by 2030, growing at a compound annual growth rate (CAGR) of 5.73% from 2023 to 2030[5].

Market Segmentation

The dapsone market is segmented based on application, type, and geography:

• Applications: The market is segmented into chemical reagents, pharmaceutical intermediates, and others. The chemical reagents segment dominated the market in 2021 due to its use in diagnosing diseases like syphilis and malaria[5].
• Geography: North America accounted for the highest market share in 2021, driven by the high prevalence of leprosy and other skin disorders, as well as the availability of effective therapies and generic versions of dapsone[5].

Drivers and Restraints

Key drivers of the dapsone market include:

• Increasing Demand: Rising demand for dapsone in treating leprosy, tuberculosis, and various skin disorders.
• Cost-Effectiveness: The availability of generic versions of dapsone makes it a cost-effective option.
• Efficacy: High success rates in treating leprosy and other skin conditions.

However, the market also faces restraints such as:

• Adverse Drug Reactions: High rates of ADRs, as observed in the DAPS-ITP trial, which can limit its use in certain conditions.
• Antibiotic Resistance: The ongoing concern of antibiotic resistance may impact the long-term use of dapsone[5].

Market Projections

Regional Analysis

The dapsone market is expected to grow across various regions:

• North America: Expected to continue leading the market due to high demand and the availability of generic versions.
• Asia Pacific: Anticipated to show significant growth driven by the increasing incidence of leprosy and other skin disorders in this region[5].

Future Opportunities

The market is poised for growth due to several opportunities:

• Expanding Applications: Dapsone’s potential in treating other infectious diseases and cancers, such as Pneumocystis jirovecii pneumonia and Kaposi sarcoma.
• Generic Market: The availability of generic dapsone is expected to increase accessibility and drive market growth[5].

Key Takeaways

• Clinical Trials: Dapsone shows limited efficacy as a second-line treatment for ITP but is effective in treating acne vulgaris.
• Market Growth: The global dapsone market is projected to grow at a CAGR of 5.73% from 2023 to 2030.
• Drivers: Increasing demand, cost-effectiveness, and efficacy in treating various conditions are key drivers.
• Restraints: Adverse drug reactions and antibiotic resistance are significant restraints.

FAQs

What are the primary applications of dapsone?

Dapsone is primarily used in treating leprosy, dermatitis herpetiformis, acne vulgaris, and certain infectious diseases like Pneumocystis jirovecii pneumonia.

What were the findings of the DAPS-ITP trial?

The DAPS-ITP trial found that dapsone as a second-line treatment for ITP had a low overall response rate and a high rate of early discontinuation due to adverse drug reactions.

How is the dapsone market expected to grow?

The dapsone market is expected to grow from USD 436.76 million in 2021 to USD 687.77 million by 2030, with a CAGR of 5.73%.

What are the main drivers of the dapsone market?

The main drivers include increasing demand for treating leprosy and other skin disorders, cost-effectiveness due to generic versions, and efficacy in various medical applications.

What are the significant restraints of the dapsone market?

Significant restraints include adverse drug reactions and the ongoing concern of antibiotic resistance.

Sources

1. Efficacy and Safety of Dapsone in Primary Immune Thrombocytopenia: Ashpublications.org
2. Global Dapsone Market Report 2024 Edition: Cognitivemarketresearch.com
3. The Unmet Need for Precision Medicine in Lyme Disease: Clarivate.com
4. Statistical Review and Evaluation Clinical Studies (ACZONE): FDA.gov
5. Dapsone Market Size, Growth, Scope, Opportunities & Forecast: Verifiedmarketresearch.com

Last updated: 2024-12-31