Doxycycline vs Isotretinoin for Acneiform Eruptions of TKI

NCT04864717 | Unknown Phase 4

• 1 other identifier: 2021-2635
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acneiform Eruptions; Cancer, Treatment-Related

Keywords

Isotretinoin; Doxycyline; Tyrosine Kinase Inhibitors; EGFR Gene Mutation

Outcome Measures

Primary Outcomes (1)

• Quantitative improvement in acneiform eruptions in cancer patients on tyrosine kinase inhibitors as defined by a change in Leeds Revised Acne Grading Scale.

  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.

  6 months

Secondary Outcomes (3)

• Quantitative change on patient's quality of life with treatment of the acneiform eruption as measured by the dermatology life quality index scale.

  6 months

• Response of malignancy to cancer therapy using RECIST v1.1 guidelines

  6 months

• Adverse events from the study medications as defined using the CTCAE version 5.0 guidelines

  6 months

Study Arms (2)

Doxycycline

ACTIVE COMPARATOR

Doxycycline 100mg po once daily x 6 months

Drug: Doxycycline 100mg po once daily x 6 months

Isotretinoin

ACTIVE COMPARATOR

Isotretinoin 40mg po once daily x 6 months

Drug: Isotretinoin 40 mg po once daily x 6 months

Interventions

Doxycycline 100mg po once daily x 6 months DRUG

active intervention

Doxycycline

Isotretinoin 40 mg po once daily x 6 months DRUG

active intervention

Isotretinoin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant must be ≥18 years of age, able to understand the study procedures, and agrees to participate in the study by providing written informed consent
• Participant has histologically- or pathologically-confirmed cancer with a known sensitizing EGFR mutation.
• Participants must have started EGFR-TKI treatment, and subsequently had an acneiform eruption rated moderate or severe per the Leeds scale.
• Participant has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
• Participant has a life expectancy of at least 3 months.
• Premenopausal participants must use highly effective method of contraception. Female participants are neither pregnant nor breastfeeding

You may not qualify if:

• Absolute contraindications: pregnancy, breastfeeding, drug allergy
• Relative contraindications:
• moderate to severe hypercholesterolemia (total cholesterol \>7.8 mmol/L)
• hypertriglyceridemia (TG \>2.55 mmol/L)
• significant hepatic dysfunction (AST \> 55IU/L, ALT \> 94 IU/L)
• suicidal ideation, pseudotumor cerebri
• refractory nausea or vomiting
• GI pathology that would prevent absorption of oral therapy.

Sponsors & Collaborators

• Lady Davis Institute: lead

Study Sites (1)

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

RECRUITING

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Related Links

• Related Info

MeSH Terms

Conditions

Acneiform Eruptions; Neoplasms, Second Primary

Interventions

Doxycycline; Isotretinoin

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Neoplasms

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Terpenes; Pigments, Biological; Biological Factors

Central Study Contacts

Kevin Pehr, MD

CONTACT

(514) 935-1051; kevin.pehr@mcgill.ca

Rachel Bierbrier

CONTACT

rmbresearch2020@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Unblinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Investigator/Chercheur Clinicien

Model Details: Two arm study: one arm isotretinoin, one arm doxycycline.

Study Record Dates

• First Submitted: November 18, 2020
• First Posted: April 29, 2021
• Study Start: September 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: September 8, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)