Recruiting

Doxycycline vs. Isotretinoin

Sponsor:

Lady Davis Institute

Code:

NCT04864717

Conditions

Acneiform Eruptions

Cancer, Treatment-Related

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Doxycycline 100mg po once daily x 6 months

Isotretinoin 40 mg po once daily x 6 months

Study Details

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

Study ID

NCT04864717

Start date

Sep 1, 2021

Status verified date

Aug, 2021

Completion date

Dec, 2022

Anticipated

Primary completion date

Dec, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. 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
2. Participant has histologically- or pathologically-confirmed cancer with a known sensitizing EGFR mutation.
3. Participants must have started EGFR-TKI treatment, and subsequently had an acneiform eruption rated moderate or severe per the Leeds scale.
4. Participant has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
5. Participant has a life expectancy of at least 3 months.
6. Premenopausal participants must use highly effective method of contraception. Female participants are neither pregnant nor breastfeeding

Exclusion Criteria:

1. Absolute contraindications: pregnancy, breastfeeding, drug allergy
2. Relative contraindications:

1. moderate to severe hypercholesterolemia (total cholesterol >7.8 mmol/L)
2. hypertriglyceridemia (TG >2.55 mmol/L)
3. significant hepatic dysfunction (AST > 55IU/L, ALT > 94 IU/L)
4. suicidal ideation, pseudotumor cerebri
5. refractory nausea or vomiting
6. GI pathology that would prevent absorption of oral therapy.

Study Design

Enrollment

98 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Doxycycline

Doxycycline 100mg po once daily x 6 months

active comparator: Isotretinoin

Isotretinoin 40mg po once daily x 6 months

Interventions

Doxycycline 100mg po once daily x 6 months

active intervention

Isotretinoin 40 mg po once daily x 6 months

active intervention

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Kevin Pehr, MD

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

Rachel Bierbrier

rmbresearch2020@gmail.com

Locations

Jewish General Hospital

Recruiting

Montreal, Quebec, Canada, H3T 1E2

More Information

Sponsor

Lady Davis Institute

Last update posted

Sep 8, 2021

Last verified

Aug, 2021

Keywords

  • Isotretinoin
  • Doxycyline
  • Tyrosine Kinase Inhibitors
  • EGFR Gene Mutation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Lady Davis Institute on 2021-09-08.