Petroleum-Based Topical Agents

Petroleum-Based Topical Agents

PEP Topic 
Skin Reactions
Description 

Petroleum-based topical agents are chemical agents or ointments for application to the skin that contain a mixture of hydrocarbons, available as over-the-counter skin protectants.  Petroleum-based products have been used in the management of skin reactions associated with cancer therapies.

Effectiveness Not Established

Research Evidence Summaries

Fluhr, J.W., Miteva, M., Primavera, G., Ziemer, M., Elsner, P., & Berardesca, E. (2007). Functional assessment of a skin care system in patients on chemotherapy. Skin Pharmacology and Physiology, 20, 253–259.

doi: 10.1159/000104423
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Study Purpose:

To evaluate the effectiveness of concomitant treatment with a cleanser (slight acidic washing) and a slightly acidic emollient (both pH 5.5) in improving symptoms of xerosis in patients receiving chemotherapy.

Sample Characteristics:

  • The study reported on a sample of 30 adult patients.
  • Patients had gastrointestinal, breast, prostate, and lung cancers, and lymphoma; were receiving chemotherapy; and were experiencing dry, sensitive skin.

Setting:

This study was conducted at Friedrich-Schiller University in Jena, Germany, and at Istituto Dermatologico San Gallicano in Rome, Italy.

Study Design:

This was a controlled, monocentric, three-week treatment trial.

Measurement Instruments/Methods:

  • Patients were assessed on days 0, 7, 14, and 21 with four electronic devices.
    • Skin pH-Meter® PH 900 to assess skin pH
    • Tewameter® TM 300 to measure transepidermal water loss (TEWL)
    • Corneometer® CM 825 to measure capecitabine-based skin hydration
    • Sebumeter® SM 815 to measure casual surface sebum content
  • Physician clinical assessment included the following.
    • Estimation of dryness symptoms with an original scale from 0 to 4
    • Visual assessment of perceived skin change with a 10-point scale
    • Physicians and patients gave subjective assessment on a questionnaire about the tolerability of both products.

Results:

  • A significant reduction in TEWL (p < 0.007) was noted over time on the treated forearm.
  • Compared to baseline, sebum content hydration values increased significantly until the end of the study (p < 0.001).
  • Casual skin surface lipids increased significantly on the treated forearm (p < 0.03).
  • No significant difference existed in pH values on both the treated and untreated forearms.
  • For the physicians' clinical assessment, a progressive improvement of all skin symptoms was recorded in the course of treatment, whereas the lowest values (e.g., the best results) were obtained on the last examination day (p < 0.001).
  • The visual assessment of the perceived change in skin state showed a significant improvement over the course of the study.
  • Both the physicians and patients considered the application of the treatment tolerable enough with a good cleansing effect, leaving a nice sensation after use.

Conclusions:

Concomitant treatment with a cleanser (slight acidic washing) and a slightly acidic emollient (both pH 5.5) was effective in improving symptoms of xerosis in patients receiving chemotherapy.

Limitations:

  • The study was not randomized or double blinded.
  • The study was funded by Sebapharma, whose products were used.

Ocvirk, J., & Cencelj, S. (2009). Management of cutaneous side-effects of cetuximab therapy in patients with metastatic colorectal cancer. Journal of the European Academy of Dermatology and Venereology, 24, 453–459.

doi: 10.1111/j.1468-3083.2009.03446.x
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Study Purpose:

To evaluate the effectiveness of various interventions to manage the skin effects of cetuximab.

Intervention Characteristics/Basic Study Process:

All 31 patients developed the typical acneform rash that occurs from six to 20 days after the first dose of cetuximab. Emollients were recommended for grade 1 acneform eruptions. For patients who developed grade 2 reactions, the same topical treatment as for grade 1 was used, with the addition of topical antibiotic treatment: 1% solution of clindamycin BID for two to three weeks until pustules ceased. The H1 antihistamine loratadine was recommended to relieve itching.

All patients were advised to wash with bath oil or shower with tepid water, avoid sun exposure, and use sunscreen products with high sun protection factor. For grade 1 rash, patients were advised to use topical preparations for moisturizing that contain dexpanthenol (e.g., Bepanthen® cream or lotion), applied BID. For grade 2 rash, patients used the same topical preparation, plus a topical antibiotic treatment. Finally, for grade 3 rash, treatment with cetuximab was discontinued until the reaction resolved and a combination of emollients, topical antibiotics, and systemic antibiotics was given.

Sample Characteristics:

  • The study reported on a sample of 31 patients with metastatic colorectal cancer who were treated with cetuximab as third-line or further-line treatment after failure with irinotecan.
  • Mean patient age was 56.3 years (range 36–76 years).
  • Nineteen patients were men, and 12 were women.

Setting:

Institute of Oncology in Ljubljana, Slovenia

Study Design:

This was a descriptive study on the effectiveness of various interventions for dermatological toxicities related to cetuximab.

Measurement Instruments/Methods:

Skin toxicity was evaluated using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.

Results:

  • Of 31 patients in this study, 6 had grade 3 rashes, 16 had grade 2 rashes, and 9 had grade 1 acne-like rashes.
  • The authors reported the numbers of patients who used various treatments, but did not report the effectiveness of emollients for grade 1 or grade 2 rashes. They stated, “Generally, for treatment of skin reactions (relief of pain, discomfort, and healing) for the patients experiencing Grade 1 acneform eruptions, the skin should be treated with emollients and moisturizers (containing dexpanthenol) to ensure a maximal hydration of the skin for at least two weeks.”

Conclusions:

Grade 3 skin rash was generally manageable with emollients, topical antibiotics, and systemic antibiotics. The effectiveness of emollients on grade 1 and 2 rashes was not reported.

Limitations:

  • This was a descriptive study, not a randomized controlled trial.
  • The sample of patient reports was small.
  • Treatment was based on expert opinion.
  • A combination of interventions was used; therefore, determining the effectiveness of the individual interventions is difficult.

Racca, P., Fanchini, L., Caliendo, V., Ritorto, G., Evangelista, W., Volpatto, R., . . . Ciuffreda, L. (2008). Efficacy and skin toxicity management with cetuximab in metastatic colorectal cancer: Outcomes from an oncologic/dermatologic cooperation. Clinical Colorectal Cancer, 7, 48–54.

doi: 10.3816/CCC.2008.n.007
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Study Purpose:

To evaluate the effectiveness of treatments for several cutaneous reactions.

Intervention Characteristics/Basic Study Process:

Rash was treated with erythromycin 4% gel, phosphate clindamycin 1.2 g and oil 100 g in cream BID, and oral doxycycline 100 mg daily for two months. Patients with grade 2 or 3 pruritus were treated with antihistamines (e.g., cetirizine). Finally, xerosis was treated with topical antibiotic ointments, soap substitutes, bath oil, and moisturizing emollients.

Sample Characteristics:

The study reported on a sample of 34 patients with metastatic colorectal cancer who were receiving cetuximab and irinotecan.

Setting:

The trial was conducted at two sites in Italy.

Study Design:

This was an open-label, uncontrolled phase 2 trial. A series of cases with significant dermatologic events (DEs) was described, and management of DEs was discussed.

Measurement Instruments/Methods:

  • Skin toxicity was evaluated with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0
  • Efficacy was evaluated locally according to the Response Evaluation Criteria in Solid Tumors (RECIST) system.

Results:

Rash:

  • Twenty of 32 patients (63%) developed a rash characterized by a pustular papular erythematous eruption.
  • Onset of eruptions was one to three weeks after therapy initiated.
  • In some cases, the investigators observed diffuse erythema with follicular papules and pustules.
  • A degree of hyperpigmentation was noted in some patients.
  • Bacterial cultures were performed when infection was possible, and no secondary infection appeared concomitantly in the patients.
  • Topical antibiotic therapy was performed until resolution of skin toxicity.
  • Seven patients required oral doxycycline 100 mg daily for two months.

Pruritus:

  • Antihistamines provided relief for patients with grade 2 or 3 pruritus.

Xerosis:

  • Xerosis was observed in 16 patients (50%).
  • After six to eight weeks of treatment, some patients developed scaly, dry, itchy skin in areas previously affected by the acneform eruptions.
  • Topical antibiotic ointments, soap substitutes, bath oil, and treatment with moisturizing emollients controlled the symptoms well.

Conclusions:

Interventions were effective in resolving the dermatologic effects of cetuximab and irinotecan.

Limitations:

  • This was an uncontrolled, nonrandomized trial.
  • A combination of interventions was used; therefore, determining the effectiveness of the individual interventions is difficult.
  • The authors stated that no established guidelines exist for the treatment of skin toxicities associated with epidermal growth factor receptor–inhibitor (EGFRI) therapy. Interventions were based on expert opinion.

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