XerosisNCT04181177
Efficacy Study of Cosmetic Product on Xerosis Induced by Systemic Anticancer Treatments
An observational study of Xerosis, run by Pierre Fabre Dermo Cosmetique at 4 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Xerosis
- What is being tested?
- Cosmetic product
- How many people
- 29 participants
- Where
- 4 sitesFrance
- Study dates
- 19 Feb 2019to 1 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
- For woman of childbearing potential: use of an effective method of contraception, as assessed by the investigator for at least 4 weeks before inclusion in the study and using it during the whole duration of the study
- Criteria related to diseases and general health:
Show all 11Show fewer
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
- Radiotherapy in progress or planned during the study
- Application of dermocorticoïdes during 5 consecutive days within the 10 days previous the visit
- Any other topical or systemic treatment previously used or on-going (other than systemic anticancer treatment and antihistaminic) liable to interfere with the study assessments or incompatible with the study procedures, according to the investigator's opinion
- Application of any other topical treatment or topical cosmetic product (except hygiene product), liable to interfere with the study assessments, according to the investigator's opinion, on the entire body, the day of the visit
Trial locations and contacts
4 sites in 1 country.
France4 sites
Centre Hospitalier de Cahors
Cahors
Centre Hospitalier de Carcassonne
Carcassonne
Centre Hospitalier de Tarbes
Tarbes
Institut Universitaire du Cancer Toulouse- Oncopole
Toulouse
About this study
Official title: Randomized, Comparative Study to Evaluate the Effects of Cosmetic Balm on Xerosis and Associated Signs and Symptoms, Induced by Systemic Anticancer Treatments in Subjects Receiving Targeted Educational Action Compared to a Control Group
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.
Read more
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.
Read the 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).
- Conditions
- Xerosis
- Being tested
- Cosmetic product
- 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)
- Medical subject headings
- Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cosmetic productOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
- 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
Measured: 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
- Grade1: Mild or localized; topical intervention indicated
- Grade2: Widespread and intermittent; skin changes from scratching (e.g., edema, papulation, excoriations, lichenification, oozing/crusts); oral intervention indicated; limiting instrumental ADL
- Grade3: Widespread and constant; limiting self care ADL or sleep; systemic corticosteroid or immunosuppressive therapy indicated
Measured: 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
- Grade1: Mild or localized; topical intervention indicated
- Grade2: Widespread and intermittent; skin changes from scratching (e.g., edema, papulation, excoriations, lichenification, oozing/crusts); oral intervention indicated; limiting instrumental ADL
- Grade3: Widespread and constant; limiting self care ADL or sleep; systemic corticosteroid or immunosuppressive therapy indicated
Measured: 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
0: absent; 1: very mild; 2: mild; 3: moderate; 4: severe
Measured: 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
0: absent; 1: very mild; 2: mild; 3: moderate; 4: severe
Measured: 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
Investigator Global Assessment (IGA) on 5-points scale
0: aggravation; 1: no change; 2: slight improvement; 3: clear improvement; 4: total improvement
Measured: 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
Patient Global Assessment (PGA) on 5-points scale
0: aggravation; 1: no change; 2: slight improvement; 3: clear improvement; 4: total improvement
Measured: once a week at home (before application if any), during 3 weeks or 4 weeks according to the frequency of participant's oncologic received treatment, for informed group, on the target area
Patient Global Assessment (PGA) on 5-points scale
0: aggravation; 1: no change; 2: slight improvement; 3: clear improvement; 4: total improvement
Measured: once a week at home (before application if any), during 6 weeks or 8 weeks according to the frequency of participant's oncologic received treatment, for control group, on the target area
dryness/tightness; tingling; warming/burning; pruritus/itching; discomfort
Numeric Scale 0-10
Measured: once a week at home (before application if any), during 3 weeks or 4 weeks according to the frequency of participant's oncologic received treatment, for informed group, on the target area
dryness/tightness; tingling; warming/burning; pruritus/itching; discomfort
Numeric Scale 0-10
Measured: once a week at home (before application if any), during 6 weeks or 8 weeks according to the frequency of participant's oncologic received treatment, for control group, on the target area
Dermatology Life Quality Index questionnaire (DLQI)
Questionnaire Score 0-30
Measured: Change from baseline to 3 weeks or 4 weeks later according to the frequency of participant's oncologic received treatment, for each group
Dermatology Life Quality Index questionnaire (DLQI)
Questionnaire Score 0-30
Measured: 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
Cosmetic acceptability questionnaire
Questionnaire ad-hoc
Measured: 3 weeks or 4 weeks according to the frequency of participant's oncologic received treatment, for informed group
Cosmetic acceptability questionnaire
Questionnaire ad-hoc
Measured: 6 weeks or 8 weeks according to the frequency of participant's oncologic received treatment, for control group
Targeted educational action questionnaire
Questionnaire ad-hoc
Measured: 3 weeks or 4 weeks according to the frequency of participant's oncologic received treatment, for informed group
Targeted educational action questionnaire
Questionnaire ad-hoc
Measured: 6 weeks or 8 weeks according to the frequency of participant's oncologic received treatment, for control group
Hydration Index (IH)
Measure by corneometer
Measured: Change from baseline to 3 weeks or 4 weeks later according to the frequency of participant's oncologic received treatment, for each group, on target area
Hydration Index (IH)
Measure by corneometer
Measured: 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 target area
Corneocytes quantification
Sampling performed with DSquame disc and image taking with C-Cube probe.
Measured: Change from baseline to 3 weeks or 4 weeks later according to the frequency of participant's oncologic received treatment, for each group, on target area
Corneocytes quantification
Sampling performed with DSquame disc and image taking with C-Cube probe.
Measured: 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 target area
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2019
- Study start19 Feb 2019
- Primary completion25 Jan 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for XerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Dermo Cosmetique
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vincent SIBAUD, Dr, Principal investigator, Institut Universitaire du Cancer Toulouse- Oncopole
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04181177
- Sponsor's protocol ID
- RV4429A2018386
- Status last verified
- Sep 2022
- First submitted
- 20 Nov 2019
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Comparative Study to Evaluate the Effects of Cosmetic Balm on Xerosis and Associated Signs and Symptoms, Induced by Systemic Anticancer Treatments in Subjects Receiving Targeted Educational Action Compared to a Control Group
- ClinicalTrials.gov ID
- NCT04181177
- Acronym / sponsor ID
- RV4429A2018386
- 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)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Pierre Fabre Dermo CosmetiqueIndustry (pharma, biotech, devices)
- Study start
- 19 Feb 2019 (actual)
- Primary completion
- 25 Jan 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 29 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Informed group | – | Other: Cosmetic productThis 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 |
| 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (11 listed)
- Criteria related to the population:
- Criteria related to diseases and general health:
- Criteria related to treatments:
Key exclusion criteria (19 listed)
- Criteria related to the population:
- Criteria related to diseases and general health
- Criteria related to treatments and cosmetic products
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cosmetic productCosmetic 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). | Other | Informed group |
Primary outcome
dry skin on scale NCI CTCAE 5.0
Time frame: 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
* 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
20 secondary outcomes
dry skin on scale NCI CTCAE 5.0
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Investigator Global Assessment (IGA) on 5-points scale
Time frame: 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
Patient Global Assessment (PGA) on 5-points scale
Time frame: once a week at home (before application if any), during 3 weeks or 4 weeks according to the frequency of participant's oncologic received treatment, for informed group, on the target area
Patient Global Assessment (PGA) on 5-points scale
Time frame: once a week at home (before application if any), during 6 weeks or 8 weeks according to the frequency of participant's oncologic received treatment, for control group, on the target area
dryness/tightness; tingling; warming/burning; pruritus/itching; discomfort
Time frame: once a week at home (before application if any), during 3 weeks or 4 weeks according to the frequency of participant's oncologic received treatment, for informed group, on the target area
dryness/tightness; tingling; warming/burning; pruritus/itching; discomfort
Time frame: once a week at home (before application if any), during 6 weeks or 8 weeks according to the frequency of participant's oncologic received treatment, for control group, on the target area
Dermatology Life Quality Index questionnaire (DLQI)
Time frame: Change from baseline to 3 weeks or 4 weeks later according to the frequency of participant's oncologic received treatment, for each group
Dermatology Life Quality Index questionnaire (DLQI)
Time frame: 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
Cosmetic acceptability questionnaire
Time frame: 3 weeks or 4 weeks according to the frequency of participant's oncologic received treatment, for informed group
Cosmetic acceptability questionnaire
Time frame: 6 weeks or 8 weeks according to the frequency of participant's oncologic received treatment, for control group
Targeted educational action questionnaire
Time frame: 3 weeks or 4 weeks according to the frequency of participant's oncologic received treatment, for informed group
Targeted educational action questionnaire
Time frame: 6 weeks or 8 weeks according to the frequency of participant's oncologic received treatment, for control group
Hydration Index (IH)
Time frame: Change from baseline to 3 weeks or 4 weeks later according to the frequency of participant's oncologic received treatment, for each group, on target area
Hydration Index (IH)
Time frame: 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 target area
Corneocytes quantification
Time frame: Change from baseline to 3 weeks or 4 weeks later according to the frequency of participant's oncologic received treatment, for each group, on target area
Corneocytes quantification
Time frame: 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 target area
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincent SIBAUD, Dr principal investigator
Institut Universitaire du Cancer Toulouse- Oncopole
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Xerosis, run by Pierre Fabre Dermo Cosmetique at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
dry skin on scale NCI CTCAE 5.0 (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2022.