Back to resultsEfficacy of the Cosmetic Product "Onco-Repair" on Grade 2 Hand Foot Syndrome (OCRP)
Primary Purpose
Grade 2 Hand-foot Syndrom
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Onco-Repair/ Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Grade 2 Hand-foot Syndrom focused on measuring Hand Foot Syndrome Grade 2, Common Terminology Criteria for Adverse Events (CTCAE), Oncology, Repair Cream, Cutaneous events, Palmar-plantar erythrodysesthesia syndrome, Targeted Therapies or Conventional Chemotherapy
Eligibility Criteria
Inclusion Criteria:
- Who suffers from grade 2 HFS
- Subject under anti-tumor treatment known to cause this toxicity: targeted therapies or conventional chemotherapy: 5-Fluorouracile, Aflibercept, Axitinib, Bévacizumab, Capécitabine, Cediranib, Cytarabine, Dabrafenib, Docétaxel, Doxorubicine, Epirubicine, Pazopanib, Sorafenib, Sunitinib, Trastuzumab, Regorafenib, Vemurafenib and any other anti-tumor treatment that may lead to this toxicity
- Subject 18 years old and more
- Subject having been informed, having signed a free, informed and written consent
- Woman of childbearing age using contraception deemed effective
Non-Inclusion Criteria:
- Pregnant or lactating women
- Subject having a history of allergic contact dermatitis or irritation to any of the components of the investigational products
- Subjects with another skin pathology that may interfere with the evaluation of a HFS (at the investigator's discretion)
- Subject under anti-inflammatory treatment
- Subject participating in another clinical study during the duration of the study, except in a study assessing one of the molecules listed in the section above
- Subject who has already been treated for Grade 2 HFS or under other local treatment or cosmetic product
- Subject refusing to interrupt the application of his/her usual care
- Subject having a strongly altered general condition and / or non-autonomous subject (Karnofsky index <50%)
- Subject in linguistic or psychic impossibility to understand and sign informed consent or in the impossibility of submitting to the medical follow-up of the study
- Subject deprived of liberty by administrative or judicial decision, or under guardianship
Sites / Locations
- Quanta Medical
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Onco-Repair
Placebo
Arm Description
Onco-Repair tube of 150 ml
Placebo tube of 150 ml
Outcomes
Primary Outcome Measures
Overall success
A subject is considered to have attained success if he achieves at least one grade improvement in HFS for the most affected palmer face according to the National Cancer Institute CTCATE V5.0 at any time during study period (28 days).
The subjects will be defined in success or failure according to the following rules:
Success: switch from grade 2 to grade 1 or grade 0 Failure: switch from grade 2 to grade 3 If subjects remain at grade 2 at the end of the study, they will be classified as either success or failure according to the evolution of clinical signs and / or quality of life assessed using the Dermatological Life Quality Index (DLQI) scale from D0 to D28.
Secondary Outcome Measures
Time to onset of grade 1 or 0 will be assessed using time (in days) from study commencement (inclusion, D0) to first occurrence of grade 1 or lower HFS according to the CTCAEV5.0
Time to onset of grade 1 or 0 will be assessed using time (in days) from study
Clinical parameters such as lesion color
Clinical parameters such as lesion color will be assessed
On e-CRF at D0, D7 and D28
from D0 to D28 using a standardized diary completed by subjects
Clinical parameters such as presence of blisters
Clinical parameters such as presence of blisters will be assessed
On e-CRF at D0, D7 and D28
from D0 to D28 using a standardized diary completed by subjects
Clinical parameters such as fissures/cracks
Clinical parameters such as fissures/cracks will be assessed
On e-CRF at D0, D7 and D28
from D0 to D28 using a standardized diary completed by subjects
Assessment of quality of life from D0 to D28 using Dermatology Life Quality Index scale
Quality of life will be assessed from D0 to D28 using Dermatology Life Quality Index scale. It is a simple 10-question validated questionnaire that has been used in over 40 different skin conditions in over 80 countries and is available in over 90 languages.
Meaning of Dermatology Life Quality Index scale Scores:
0 to 1 = no effect at all on patient's life 2 to 5 = small effect on patient's life 6 to 10 = moderate effect on patient's life 11 to 20 = very large effect on patient's life 21 to 30 = extremely large effect on patient's life
Assessment of symptoms
Such as intensity of lesions, feeling of subjects, etc will be assessed: on e-CRF at D0, D7 and D28, from D0 to D28 using a standardized diary completed by subjects
Assessment of pain score and prurit at D0, D7 and D28 using a 100 Visual Analogue Scale [Visual analogue scale, 0 (no pain, no prurit) and 100 (worst possible pain or prurit)]
Pain score and prurit will be assessed at D0, D7 and D28 using a 100 Visual Analogue Scale [Visual analogue scale , 0 (no pain, no prurit) and 100 (worst possible pain or prurit)]
Assessment of the repair quality of skin
The repair quality of skin will be assessed from D0, D7 and D28 using a standardized diary completed by subjects.
Cosmetic parameters such as nourishing power of the cream will be assessed at D28 using a standardized diary
Nourishing power will be assessed at D28 using a standardized diary completed by subjects.
Cosmetic parameters such as soothing power of the cream will be assessed at D28 using a standardized diary
Soothing power will be assessed at D28 using a standardized diary completed by subjects.
Cosmetic parameters such as penetration power of the cream will be assessed at D28 using a standardized diary
Penetration power will be assessed at D28 using a standardized diary completed by subjects.
Assessment of compliance
The compliance will be assessed at the end of the study: subject will be considered to be compliant if he/she applied at least the theoretical consumption of 60% of the product.
The overall tolerance will be assessed by the investigator (Subject interrogation). This evaluation will be carried out during visits using the following rating: 1 = Very good tolerance 2 = Good tolerance 3 = Middle tolerance 4 = Poor tolerance
= Very good tolerance: no functional signs of discomfort and no objective signs during examination
= Good tolerance: some functional signs of minimal and transient discomfort that did not interrupt the applications and no objective signs during examination
= Middle tolerance: functional signs of discomfort, net or persistent, or objective signs during examination that did not interrupt the applications of the investigationalproduct
= Poor tolerance: functional and / or objectives signs leading to discontinuation of the use of the investigational product
Safety will be will be evaluated in terms of: - the number of subjects presenting during the study period at least : One AE/ One SAE - the total number of AEs during the study period - the total number of SAEs during the study period
Safety will be assessed on the basis of adverse event (AE) reports
Full Information
NCT ID
NCT03612011
First Posted
July 12, 2018
Last Updated
September 4, 2019
Sponsor
Quanta Medical
Collaborators
NAOS Institute of Life Science
1. Study Identification
Unique Protocol Identification Number
NCT03612011
Brief Title
Efficacy of the Cosmetic Product "Onco-Repair" on Grade 2 Hand Foot Syndrome
Acronym
OCRP
Official Title
Evaluation of the Restorative Efficacy of the Cosmetic Product "Onco-Repair" vs. Placebo on Grade 2 Hand Foot Syndrome Induced by Targeted Therapies or Conventional Chemotherapy. Randomized, Multicentre, Double Blind, Controlled Study Versus Placebo.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
July 12, 2018 (Actual)
Primary Completion Date
August 1, 2018 (Actual)
Study Completion Date
June 2, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Quanta Medical
Collaborators
NAOS Institute of Life Science
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of the study is to assess the restorative efficacy of the cosmetic product "Onco-Repair" vs placebo of the most affected palmer face in subject with grade 2 HFS induced by targeted therapies or conventional chemotherapy.
Detailed Description
HFS, also known as Palmar-Plantar Erythrodysethesia, is a common adverse event observed in subjects under anti-tumor therapy with conventional chemotherapy or targeted thérapies. The initial symptoms are dysesthesia and tingling in the palms, fingers and soles of feet and erythema, which may progress to burning pain with dryness, cracking, desquamation, ulceration and oedema. Sensory impairment, paresthesia and pruritus have also been reported. Palms of the hands are more frequently affected than soles of the feet, and might even be the only area affected in some subjects.
Although HFS is rarely life-threatening, the skin changes are often painful and debilitating and can impair with the general activities of daily living and quality of life. No standard prevention for HFS has not been established yet.
Onco-Repair is a nourishing and repairing cream specially formulated to treat grade 2 HFS which demonstrate skin tolerance, hypoallergenicity and efficacy through several preclinical and clinical studies on healthy subjects.
Therefore, a randomized, double-blind, placebo-controlled study will be conducted to evaluate efficacy and safety of topical cream 'Onco-Repair' on HFS.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Grade 2 Hand-foot Syndrom
Keywords
Hand Foot Syndrome Grade 2, Common Terminology Criteria for Adverse Events (CTCAE), Oncology, Repair Cream, Cutaneous events, Palmar-plantar erythrodysesthesia syndrome, Targeted Therapies or Conventional Chemotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Phase III multicenter, double blind, superiority, prospective, randomised controlled study Subjects will be randomized to receive either cosmetic product "Onco-Repair" or placebo in a 1:1 ratio
Masking
ParticipantInvestigator
Masking Description
Cosmetic product "Onco-Repair" and placebo will be filled in the tubes with same appearance and smell. The tubes will be marked anonymusioly
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Onco-Repair
Arm Type
Experimental
Arm Description
Onco-Repair tube of 150 ml
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tube of 150 ml
Intervention Type
Other
Intervention Name(s)
Onco-Repair/ Placebo
Intervention Description
Cream must be applied twice a day, in the morning and evening, on the hands and feet (palmo-plantar areas and interdigital spaces included) previously cleaned with Atoderm Intensive Foaming Gel, chosen as a standardized hygiene product.
Primary Outcome Measure Information:
Title
Overall success
Description
A subject is considered to have attained success if he achieves at least one grade improvement in HFS for the most affected palmer face according to the National Cancer Institute CTCATE V5.0 at any time during study period (28 days).
The subjects will be defined in success or failure according to the following rules:
Success: switch from grade 2 to grade 1 or grade 0 Failure: switch from grade 2 to grade 3 If subjects remain at grade 2 at the end of the study, they will be classified as either success or failure according to the evolution of clinical signs and / or quality of life assessed using the Dermatological Life Quality Index (DLQI) scale from D0 to D28.
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Time to onset of grade 1 or 0 will be assessed using time (in days) from study commencement (inclusion, D0) to first occurrence of grade 1 or lower HFS according to the CTCAEV5.0
Description
Time to onset of grade 1 or 0 will be assessed using time (in days) from study
Time Frame
28 days
Title
Clinical parameters such as lesion color
Description
Clinical parameters such as lesion color will be assessed
On e-CRF at D0, D7 and D28
from D0 to D28 using a standardized diary completed by subjects
Time Frame
Day 0 (inclusion) , Day 7 and Day 28
Title
Clinical parameters such as presence of blisters
Description
Clinical parameters such as presence of blisters will be assessed
On e-CRF at D0, D7 and D28
from D0 to D28 using a standardized diary completed by subjects
Time Frame
Day 0 (inclusion) , Day 7 and Day 28
Title
Clinical parameters such as fissures/cracks
Description
Clinical parameters such as fissures/cracks will be assessed
On e-CRF at D0, D7 and D28
from D0 to D28 using a standardized diary completed by subjects
Time Frame
Day 0 (inclusion) , Day 7 and Day 28
Title
Assessment of quality of life from D0 to D28 using Dermatology Life Quality Index scale
Description
Quality of life will be assessed from D0 to D28 using Dermatology Life Quality Index scale. It is a simple 10-question validated questionnaire that has been used in over 40 different skin conditions in over 80 countries and is available in over 90 languages.
Meaning of Dermatology Life Quality Index scale Scores:
0 to 1 = no effect at all on patient's life 2 to 5 = small effect on patient's life 6 to 10 = moderate effect on patient's life 11 to 20 = very large effect on patient's life 21 to 30 = extremely large effect on patient's life
Time Frame
28 days
Title
Assessment of symptoms
Description
Such as intensity of lesions, feeling of subjects, etc will be assessed: on e-CRF at D0, D7 and D28, from D0 to D28 using a standardized diary completed by subjects
Time Frame
Day 0 (inclusion) , Day 7 and Day 28
Title
Assessment of pain score and prurit at D0, D7 and D28 using a 100 Visual Analogue Scale [Visual analogue scale, 0 (no pain, no prurit) and 100 (worst possible pain or prurit)]
Description
Pain score and prurit will be assessed at D0, D7 and D28 using a 100 Visual Analogue Scale [Visual analogue scale , 0 (no pain, no prurit) and 100 (worst possible pain or prurit)]
Time Frame
Day 0 (inclusion) , Day 7 and Day 28
Title
Assessment of the repair quality of skin
Description
The repair quality of skin will be assessed from D0, D7 and D28 using a standardized diary completed by subjects.
Time Frame
Day 0 (inclusion) , Day 7 and Day 28
Title
Cosmetic parameters such as nourishing power of the cream will be assessed at D28 using a standardized diary
Description
Nourishing power will be assessed at D28 using a standardized diary completed by subjects.
Time Frame
28 days
Title
Cosmetic parameters such as soothing power of the cream will be assessed at D28 using a standardized diary
Description
Soothing power will be assessed at D28 using a standardized diary completed by subjects.
Time Frame
28 days
Title
Cosmetic parameters such as penetration power of the cream will be assessed at D28 using a standardized diary
Description
Penetration power will be assessed at D28 using a standardized diary completed by subjects.
Time Frame
28 days
Title
Assessment of compliance
Description
The compliance will be assessed at the end of the study: subject will be considered to be compliant if he/she applied at least the theoretical consumption of 60% of the product.
Time Frame
28 days
Title
The overall tolerance will be assessed by the investigator (Subject interrogation). This evaluation will be carried out during visits using the following rating: 1 = Very good tolerance 2 = Good tolerance 3 = Middle tolerance 4 = Poor tolerance
Description
= Very good tolerance: no functional signs of discomfort and no objective signs during examination
= Good tolerance: some functional signs of minimal and transient discomfort that did not interrupt the applications and no objective signs during examination
= Middle tolerance: functional signs of discomfort, net or persistent, or objective signs during examination that did not interrupt the applications of the investigationalproduct
= Poor tolerance: functional and / or objectives signs leading to discontinuation of the use of the investigational product
Time Frame
28 days
Title
Safety will be will be evaluated in terms of: - the number of subjects presenting during the study period at least : One AE/ One SAE - the total number of AEs during the study period - the total number of SAEs during the study period
Description
Safety will be assessed on the basis of adverse event (AE) reports
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Who suffers from grade 2 HFS
Subject under anti-tumor treatment known to cause this toxicity: targeted therapies or conventional chemotherapy: 5-Fluorouracile, Aflibercept, Axitinib, Bévacizumab, Capécitabine, Cediranib, Cytarabine, Dabrafenib, Docétaxel, Doxorubicine, Epirubicine, Pazopanib, Sorafenib, Sunitinib, Trastuzumab, Regorafenib, Vemurafenib and any other anti-tumor treatment that may lead to this toxicity
Subject 18 years old and more
Subject having been informed, having signed a free, informed and written consent
Woman of childbearing age using contraception deemed effective
Non-Inclusion Criteria:
Pregnant or lactating women
Subject having a history of allergic contact dermatitis or irritation to any of the components of the investigational products
Subjects with another skin pathology that may interfere with the evaluation of a HFS (at the investigator's discretion)
Subject under anti-inflammatory treatment
Subject participating in another clinical study during the duration of the study, except in a study assessing one of the molecules listed in the section above
Subject who has already been treated for Grade 2 HFS or under other local treatment or cosmetic product
Subject refusing to interrupt the application of his/her usual care
Subject having a strongly altered general condition and / or non-autonomous subject (Karnofsky index <50%)
Subject in linguistic or psychic impossibility to understand and sign informed consent or in the impossibility of submitting to the medical follow-up of the study
Subject deprived of liberty by administrative or judicial decision, or under guardianship
Facility Information:
Facility Name
Quanta Medical
City
Rueil-Malmaison
ZIP/Postal Code
92500
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
19923864
Citation
Lipworth AD, Robert C, Zhu AX. Hand-foot syndrome (hand-foot skin reaction, palmar-plantar erythrodysesthesia): focus on sorafenib and sunitinib. Oncology. 2009;77(5):257-71. doi: 10.1159/000258880. Epub 2009 Nov 16.
Results Reference
background
PubMed Identifier
21113620
Citation
Zhang RX, Wu XJ, Lu SX, Pan ZZ, Wan DS, Chen G. The effect of COX-2 inhibitor on capecitabine-induced hand-foot syndrome in patients with stage II/III colorectal cancer: a phase II randomized prospective study. J Cancer Res Clin Oncol. 2011 Jun;137(6):953-7. doi: 10.1007/s00432-010-0958-9. Epub 2010 Nov 27.
Results Reference
background
Learn more about this trial
Efficacy of the Cosmetic Product "Onco-Repair" on Grade 2 Hand Foot Syndrome
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