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

NCT04181177 | Completed

• 1 other identifier: RV4429A2018386
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 4

Brief 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

Xerosis

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)

Outcome Measures

Primary Outcomes (1)

• dry skin on scale NCI CTCAE 5.0

  * Grade1: Covering \<10% BSA\* and no associated erythema or pruritus * Grade2: Covering 10 - 30% BSA\* and associated with erythema or pruritus; limiting instrumental ADL\* * Grade3: Covering \>30% BSA\* and associated with pruritus; limiting self care ADL\* \* BSA : Body Surface Area, ADL : Activities of Daily Living

  Change from baseline to 3 weeks or 4 weeks later according to the frequency of participant's oncologic received treatment, for each group, on the entire body

Secondary Outcomes (20)

• dry skin on scale NCI CTCAE 5.0

  Day 21 or Day 28 (according to the frequency of participant's oncologic received treatment) and Day 42 or Day 56 (according to the frequency of participant's oncologic received treatment), for group control, on the entire body

• pruritus on scale NCI CTCAE 5.0

  Change from baseline to 3 weeks or 4 weeks later according to the frequency of participant's oncologic received treatment, for each group, on the entire body

• pruritus on scale NCI CTCAE 5.0

  Day 21 or Day 28 (according to the frequency of participant's oncologic received treatment) and Day 42 or Day 56 (according to the frequency of participant's oncologic received treatment), for each group, on the entire body

• dry skin on 5-points scale

  Change from baseline to 3 weeks or 4 weeks later according to the frequency of participant's oncologic received treatment, for each group, on the target area

• dry skin on 5-points scale

  Day 21 or Day 28 (according to the frequency of participant's oncologic received treatment) and Day 42 or Day 56 (according to the frequency of participant's oncologic received treatment), for each group, on the target area

Study Arms (2)

Informed group

This group will receive the Cosmetic product RV4429A balm and targeted educational action between V1 and V2 or between V2 and V3 according to the randomization

Other: Cosmetic product

Control group

The control group, in the first period between V1 and V2, is a group not informed about his skin condition, not receiving any emollient product and not receiving targeted educational action. It's representative of the real life called "best supportive care/Supportive care": the doctor prescribes what it seems to be the best for his patient according to his opinion in view of his condition, at a given moment. A high variability exists within this group. In order to answer the investigator's hypothesis and demonstrate the effectiveness of the RV4429A balm, the parallel group design is chosen for the first follow-up period and then a second follow-up period is chosen for the initial control group to replace the inter-individual variability by intra-individual variability.

Interventions

Cosmetic product OTHER

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).

Informed group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Criteria related to the population:
• Subject having signed his/her written informed consent for his/her participation in the study
• Subject affiliated to a social security system or health insurance, or is a beneficiary
• Subject with phototype I, II, III, IV according to the Fitzpatrick scale
• Criteria related to diseases and general health:
• Subject having a grade ≥ 2 of dry skin on NCI-CTCAE scale in 3 grades, assessed on the entire body
• Subject having an intensity of dry skin ≥ 3, according a 5-points scale, on the target area
• Subject having a general state of clinical and/or physical health adequate(s) to carry out the study according to the investigator's opinion, and presenting a total score ≤ 1 according to the "performance status" scale of WHO (World Health Organization) in 5-points
• Criteria related to treatments:
• On-going systemic anticancer treatment, whatever the dosage and whatever the duration of treatment

You may not qualify if:

• Criteria related to the population:
• For woman of childbearing potential: pregnant or breastfeeding or planning to be pregnant during the study
• Subject unable to understand the information given including study procedures (for linguistic or psychiatric reasons) and to give his/her consent in writing
• Subject who, in the judgement of the investigator, is not likely to be compliant during the study
• Subject who has forfeited his/her freedom by administrative or legal award or is under guardianship
• Subject is in a position likely to represent a conflict of interest and/or is a family member of any people involved in the conduct of the study (secretary, nurse, technician,…), of the investigational site
• Subject who is currently participating, who plans to participate or who has participated within the previous weeks in another clinical study liable to interfere with the study assessments according to the investigator's assessment
• Subject unable to write required information in a subject diary
• Criteria related to diseases and general health
• Subject having a grade= 3 of pruritus on NCI-CTCAE scale in 3 grades, assessed on the entire body
• Subject presenting infectious (viral, bacterial, fungal) or inflammatory complications, on the entire body
• Subject with a history of atopic or contact dermatitis
• Subject presenting any other dermatological condition the day of the visit (atopic or contact dermatitis, chronic xerosis, ..), liable to interfere with the study assessments, according to the investigator's opinion
• Subject with history of allergy or intolerance to any of the study products ingredients
• Criteria related to treatments and cosmetic products

Sponsors & Collaborators

• Pierre Fabre Dermo Cosmetique: lead

Study Sites (4)

Centre Hospitalier de Cahors

Cahors, France

Location

Centre Hospitalier de Carcassonne

Carcassonne, France

Location

Centre Hospitalier de Tarbes

Tarbes, France

Location

Institut Universitaire du Cancer Toulouse- Oncopole

Toulouse, France

Location

MeSH Terms

Conditions

Pruritus

Interventions

Cosmetics

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specialty Uses of Chemicals; Chemical Actions and Uses; Household Products; Technology, Industry, and Agriculture

Study Officials

• Vincent SIBAUD, Dr

  Institut Universitaire du Cancer Toulouse- Oncopole

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2019
• First Posted: November 29, 2019
• Study Start: February 19, 2019
• Primary Completion: January 25, 2022
• Study Completion: March 1, 2022
• Last Updated: September 28, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)