Analysis of the stratum corneum structure in the patients taking erlotinib -Towards the investigation of the mechanism of skin rash by the development of erlotinib administration-

Analysis of the stratum corneum structure in the patients taking erlotinib -Towards the investigation of the mechanism of skin rash by the development of erlotinib administration- - Analysis of the stratum corneum structure in the patients taking erlotinib

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000020675

Enrollment

Registered

2016-01-21

Start date

2014-09-29

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Non-small cell lung cancer

Interventions

Analysis of startum corneum of the patients with orally administrating erlotinib Erlotinib dose : 150mg (once daily) The stratum corneum of patients will be removed by tape stripping method on da

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients who are histologically diagnosed with non-small cell clung cancer 2. Patinents who are recurrent or progressive non-small-cell lung cancer 3. More than 20-years olds patients at the time of enrollement 4. ECOG Performance status of 0-2 5. Patients who are possible oral ingestion 6. Patients who are expected to survive more than 3 months from the time of enrollment 7. Patients who provide written informed consent for entry of this trial 8. Having adequate bone marrow, liver, renal, and respiratory function i. White blood cell; more than 3,000/mm3 (or Neutrophil; more than 1,500/mm3) ii. Platelet; more than 100,000/mm3 iii. Hemoglobin; more than 9.0g/dL iv. Serum total bilirubin (T-Bil); within 1.5XULN (institutional reference values) v. Transaminases (AST and ALT); within 2.5XULN vi. Serum total bilirubin (T-Bil); within 1.5XULN

Exclusion criteria

Exclusion criteria: 1. Patients with a history of allergy for a component of erlotinib 2. Patients with a history of EGFR inhibitor treatment before erlotinib administration (except for the patients with gefitinib treatment before erlotinib administration) 3. Patients with a history of serious drug allergy 4. Patients with other serious complications 5. Patients with a history of serious drug allergy 6. Patients who are in pregnancy or intend to get pregnant 7. Patients who are considered to be inappropriate in enrollment of this trial by attending physicians 8. Patients with orally steroid treatment

Design outcomes

Primary

Measure	Time frame
Transepidermal water loss(TEWL), Analysis of ceramide components, lateral structure of stratum corneum	—

Countries

Japan

Contacts

Public ContactTomonobu Uchino

Univercity of Shizuoka Department of Clinical Pharmaceutics, School of Pharmaceutical Sciences,

uchinot@u-shizuoka-ken.ac.jp054-264-5771

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026