Clinical trial · Interventional
Doxycycline vs Isotretinoin for Acneiform Eruptions of TKI
A Randomized Control Trial to Compare Doxycycline to Isotretinoin for the Treatment of Acneiform Eruptions in Cancer Patients on Tyrosine Kinase Inhibitors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acneiform Eruptions | — | UNRESOLVED | — |
| Cancer, Treatment-Related | Malignant Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Doxycycline 100mg po once daily x 6 months | Drug | — | UNRESOLVED |
| Isotretinoin 40 mg po once daily x 6 months | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Doxycycline
- description
- Doxycycline 100mg po once daily x 6 months
- interventionNames
- Drug: Doxycycline 100mg po once daily x 6 months
- type
- ACTIVE_COMPARATOR
- label
- Isotretinoin
- description
- Isotretinoin 40mg po once daily x 6 months
- interventionNames
- Drug: Isotretinoin 40 mg po once daily x 6 months
Primary outcomes (1)
- measure
- Quantitative improvement in acneiform eruptions in cancer patients on tyrosine kinase inhibitors as defined by a change in Leeds Revised Acne Grading Scale.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (30)
- BACKGROUNDAgnew T, Furber G, Leach M, Segal L. A Comprehensive Critique and Review of Published Measures of Acne Severity. J Clin Aesthet Dermatol. 2016 Jul;9(7):40-52. Epub 2016 Jul 1. PMID 27672410
- BACKGROUNDGutzmer R, Werfel T, Mao R, Kapp A, Elsner J. Successful treatment with oral isotretinoin of acneiform skin lesions associated with cetuximab therapy. Br J Dermatol. 2005 Oct;153(4):849-51. doi: 10.1111/j.1365-2133.2005.06835.x. No abstract available. PMID 16181478
- BACKGROUNDAndrews ED, Garg N, Patel AB. A retrospective chart review on oral retinoids as a treatment for epidermal growth factor receptor inhibitor- and mitogen-activated protein kinase kinase inhibitor-induced acneiform eruptions. J Am Acad Dermatol. 2020 Apr;82(4):998-1000. doi: 10.1016/j.jaad.2019.10.003. Epub 2019 Oct 8. No abstract available. PMID 31604105
- BACKGROUNDEisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026. PMID 19097774
- BACKGROUNDScope A, Agero AL, Dusza SW, Myskowski PL, Lieb JA, Saltz L, Kemeny NE, Halpern AC. Randomized double-blind trial of prophylactic oral minocycline and topical tazarotene for cetuximab-associated acne-like eruption. J Clin Oncol. 2007 Dec 1;25(34):5390-6. doi: 10.1200/JCO.2007.12.6987. PMID 18048820
- BACKGROUNDGerber PA, Meller S, Eames T, Buhren BA, Schrumpf H, Hetzer S, Ehmann LM, Budach W, Bolke E, Matuschek C, Wollenberg A, Homey B. Management of EGFR-inhibitor associated rash: a retrospective study in 49 patients. Eur J Med Res. 2012 Feb 23;17(1):4. doi: 10.1186/2047-783X-17-4. PMID 22472354
- Lewis V, Finlay AY. 10 years experience of the Dermatology Life Quality Index (DLQI). J Investig Dermatol Symp Proc. 2004 Mar;9(2):169-80. doi: 10.1111/j.1087-0024.2004.09113.x. No abstract available.