Efficacy Study of Cosmetic Product on Xerosis Induced by Systemic Anticancer Treatments
Condition: Xerosis
Study type: Observational

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.
    

Detailed description: 
      Systemic anticancer treatments, whether they are conventional molecules or more current
      molecules such as targeted therapies, are responsible for numerous dermatological adverse
      effects, notably xerosis, the repercussions of which may lead to a decrease in compliance,
      dose reductions or even a complete cessation of cancer treatment.

      To date, the management of these adverse effects is not performed routinely and published
      efficacy data on secondary side effects are missing.

      The purpose of this comparative study is to evaluate the clinical efficacy of the RV4429A
      balm combined with a targeted educational action, on the improvement of induced xerosis on
      the one hand and on the improvement of the signs and symptoms associated with this induced
      xerosis. on the other hand ; based on clinical, biometrological and biological criteria. The
      objective is to provide data on this product in this symptomatology.

      Xerosis and the associated dermatological signs / symptoms will be assessed individually as
      well as through overall scores, as measured by both the investigator and the patient as
      clinical expression is often poorly correlated with psychic and functional impact. Quality of
      life, cosmetic acceptability and targeted educational action and tolerance will also be
      assessed.

      The improvement of the quality of life of the patients, the reduction of the undesirable
      effects induced could thus guarantee the observance of the patients vis-à-vis the anticancer
      treatments.

      The study area is the whole body. A target area will be chosen and will be located on one of
      the upper limbs (outside the hands) or on the trunk (outside a hairy area). The target area
      is defined as the xerosis area representative of the the most severe xerotic state, according
      to the investigator's opinion.

      The dermatologist who will evaluate the participant should be, as far as possible, the same
      throughout the study.

      A second period will be carried out by the participants of the control group who will enter
      in the targeted educational action phase of in their turn.

      The study includes 2 visits for the informed group and 3 visits for the control group:

        -  V1 (J1) - Inclusion (common to both groups)

        -  V2 (J21 ± 2J or J28 ± 2J) - End of study (informed group) - Intermediate (control group)

        -  V3 (J42 ± 2J or J56 ± 2J) - End of study (control group) The dates of the visits 2 and 3
           will be adapted to the frequency of the visits of administration of the anticancer
           treatment.

      The maximum duration of participation for a participant may be 23 days or 44 days or it may
      be 30 days or 58 days from the inclusion visit to the end-of-study visit, depending on the
      group and depending the timeframe between cancer treatment visits.

      All subjects in the control group will enter onto the informed group after three weeks or one
      month (depending on the timeframe between cancer treatment visits), regardless of their
      condition (presence or absence of on-going xerosis).
    

Intervention name(s): Cosmetic product
Intervention type(s): Other
Intervention description(s): 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).
Observational model: Other
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        Subjects are selected during their usual medical care with their oncologist in the
        investigational site.

        Subjects The subjects corresponding to eligibility criteria may receive a phone call, a
        letter or an e-mail proposing to participate to the study.
      
Keywords: anticancer treatment; targeted educational action; pruritus; quality of life; NCI CTCAE; Patient Global Assessment; Investigator Global Assessment; Dermatology Life Quality Index (DLQI); Hydration Index (HI); Numeric Scale (NS)