A phase II trial assessing dapsone topical gel in the prevention and treatment of erlotinib associated rash

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-000390-30-FI

Enrollment

Registered

2006-03-30

Start date

2006-05-18

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The study population are patients with non-small cell lung carcinoma eligible for treatment with erlotinib (TarcevaTM). A significant number of these patients develop acne-like rash as a side effect of erlotinib.

Interventions

Trade Name: Aczone Product Name: Aczone Pharmaceutical Form: Gel INN or Proposed INN: Dapsone CAS Number: 80-08-0 Concentration unit: % percent Concentration type: equal Concentration number: 5- Pharm

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients on erlotinib treatment: Written informed consent to participate in the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Hypersensitivity to dapsone

Design outcomes

Primary

Measure	Time frame
Secondary Objective: 1. Toxicity of dapsone topical gel 2. To identify whether appearance and intensity of erlotinib associated rash is related to serum erlotinib concentration;Primary end point(s): Primary endpoints: 1. To identify whether dapsone topical gel is effective in the pre-vention of erlotinib associated rash. 2. To identify whether dapsone topical gel is effective in the treat-ment of erlotinib associated rash.;Main Objective: A side effect specific to EGFR inhibitors is the development of a papulopustular or acne-like rash primarily on the face, neck, and upper torso. It affects approximately 70% of erlotinib treated patients and is associated with better response and/or survival. There are currently no clear guidelines for rash management and the main objective of this trial is to assess topical dapsone (dapsone gel 5%, AczoneTM) in the prevention and treatment of the rash.	—

Measure

Time frame

Secondary Objective: 1. Toxicity of dapsone topical gel 2. To identify whether appearance and intensity of erlotinib associated rash is related to serum erlotinib concentration;Primary end point(s): Primary endpoints: 1. To identify whether dapsone topical gel is effective in the pre-vention of erlotinib associated rash. 2. To identify whether dapsone topical gel is effective in the treat-ment of erlotinib associated rash.;Main Objective: A side effect specific to EGFR inhibitors is the development of a papulopustular or acne-like rash primarily on the face, neck, and upper torso. It affects approximately 70% of erlotinib treated patients and is associated with better response and/or survival. There are currently no clear guidelines for rash management and the main objective of this trial is to assess topical dapsone (dapsone gel 5%, AczoneTM) in the prevention and treatment of the rash.

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Countries

Finland

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026