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Efficacy Study of Cosmetic Product on Xerosis Induced by Systemic Anticancer Treatments

NCT04181177 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 29

Last updated 2022-09-28

No results posted yet for this study

Summary

Xerosis is one of the most common adverse events in patients treated with new cancer therapies and chemotherapies, such as multi-kinase inhibitors and more specifically, immunological checkpoint inhibitors used in the treatment of several cancers.

Xerosis appears as a result of a deterioration of the stratum corneum which results in a reduction of the hydric power of the skin. It reaches the trunk and limbs, with an incidence of 4-35%, and gradually disappears after the end of treatment.

Preventive targeted educational action is essential before initiation of cancer treatment. Once the xerosis is installed, the management is based on the use of emollients to contribute to the hydric correction of the skin. In the case of inflammation or associated infection, the administration of topical corticosteroids and / or local or oral antibiotic therapy is prescribed.

The aim of this study is to evaluate the efficacy of the cosmetic product (balm) on the improvement of xerosis induced by systemic anticancer treatments, in participants receiving targeted educational action compared to a control group.

Clinical, biological and biometrological assessments will be performed to characterized the effects in both induced xerosis and associated signs and symptoms.

Each group will include 40 participants.

Conditions

Interventions

OTHER

Cosmetic product

Cosmetic balm: application twice daily on the whole body in sufficient quantity to cover all the xerosis areas. It contains an I-modulia(r) complex which decreases the sensation of itching, CER-OMEGA which are lipids similar to those of the skin, help repair and nourish the skin, finally Avène Thermal Spring Water which have soothing and softening properties. Targeted education action consist in advices and preventive measures (including hygiene) regarding xerosis and associated dermatological signs / symptoms. Emollient and application tips and other supportive care tips will be provided. The targeted educational action will be monitored by the medical and paramedical teams (specialized nurses).

Sponsors & Collaborators

  • Pierre Fabre Dermo Cosmetique

    lead INDUSTRY

Principal Investigators

  • Vincent SIBAUD, Dr · Institut Universitaire du Cancer Toulouse- Oncopole

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-19
Primary Completion
2022-01-25
Completion
2022-03-01

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04181177 on ClinicalTrials.gov