Doxycycline vs Isotretinoin for Acneiform Eruptions of TKI
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04864717|
Recruitment Status : Not yet recruiting
First Posted : April 29, 2021
Last Update Posted : May 4, 2021
Tyrosine Kinase inhibitors (TKIs) have become standard of care in patients with EGFR mutations in non-small cell lung cancer and other EGFR-mutated cancers. However, TKIs are well-known to cause cutaneous adverse events, including acneiform eruptions. Moderate to severe acneiform eruptions are often associated with severe pruritus and pain. Current treatment recommendations rely on expert consensus. Moderate and severe reactions requiring systemic therapy, usually tetracycline antibiotics or isotretinoin. No randomized trial has compared the relative effectiveness of tetracyclines versus isotretinoin.
The objective of this unblinded, randomized trial is to compare tetracyclines to isotretinoin for treatment of moderate to severe acneiform eruptions in cancer patients on tyrosine kinase inhibitors. The primary aim of this clinical trial is to elucidate which systemic treatment is more effective in clearing acneiform eruptions caused by TKIs. The results of this study will add to the literature in this field and will aid in developing evidence based clinical guidelines.
|Condition or disease||Intervention/treatment||Phase|
|Acneiform Eruptions Cancer, Treatment-Related||Drug: Doxycycline 100mg po once daily x 6 months Drug: Isotretinoin 40 mg po once daily x 6 months||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||98 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Two arm study: one arm isotretinoin, one arm doxycycline.|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Control Trial to Compare Doxycycline to Isotretinoin for the Treatment of Acneiform Eruptions in Cancer Patients on Tyrosine Kinase Inhibitors|
|Estimated Study Start Date :||June 2021|
|Estimated Primary Completion Date :||June 2022|
|Estimated Study Completion Date :||June 2022|
Active Comparator: Doxycycline
Doxycycline 100mg po once daily x 6 months
Drug: Doxycycline 100mg po once daily x 6 months
Active Comparator: Isotretinoin
Isotretinoin 40mg po once daily x 6 months
Drug: Isotretinoin 40 mg po once daily x 6 months
- Quantitative improvement in acneiform eruptions in cancer patients on tyrosine kinase inhibitors as defined by a change in Leeds Revised Acne Grading Scale. [ Time Frame: 6 months ]Change in Leeds revised acne grading scale score between the baseline visit and six months or end of treatment with tyrosine kinase inhibitor, whichever is sooner. Leeds revised acne score ranges from 1 to 28, with higher being worse. Mild defined as 3-8, moderate defined as 11-20 and severe defined as 21-28.
- Quantitative change on patient's quality of life with treatment of the acneiform eruption as measured by the dermatology life quality index scale. [ Time Frame: 6 months ]Patients' perception of the severity of the eruption, and its impact on their lives, before, during and after therapy using the dermatology life quality index scale, range 0-40, with higher being worse
- Response of malignancy to cancer therapy using RECIST v1.1 guidelines [ Time Frame: 6 months ]To assess response of the primary malignancy to tyrosine kinase inhibitor therapy while on the study medication using the oncology standard of care RECIST v1.1 guidelines: Complete response (CR), Partial response (PR), Stable disease (SD), Progressive disease (PD)
- Adverse events from the study medications as defined using the CTCAE version 5.0 guidelines [ Time Frame: 6 months ]To assess adverse events from combined therapy study medication and TKI using the National Institute of Health CTCAE version 5.0 guidelines. Link: https://ctep.cancer.gov/protocoldevelopment/electronic_applications/docs/ctcae_v5_quick_reference_8.5x11.pdf
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04864717
|Contact: Kevin Pehr, MD||(514) firstname.lastname@example.org|
|Contact: Rachel Bierbrieremail@example.com|