Efficacy of the Cosmetic Product "Onco-Repair" on Grade 2 Hand Foot Syndrome (OCRP)

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.

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.

Study Overview

• Status: Completed
• Conditions: Grade 2 Hand-foot Syndrom
• Intervention / Treatment: Other: Onco-Repair/ Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Rueil-Malmaison, France, 92500
    • Quanta Medical

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Onco-Repair; Onco-Repair tube of 150 ml	Other: Onco-Repair/ Placebo; 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.
Placebo Comparator: Placebo; Placebo tube of 150 ml	Other: Onco-Repair/ Placebo; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	28 days
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	Day 0 (inclusion) , Day 7 and Day 28
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	Day 0 (inclusion) , Day 7 and Day 28
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	Day 0 (inclusion) , Day 7 and Day 28
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	28 days
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	Day 0 (inclusion) , Day 7 and Day 28
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)]	Day 0 (inclusion) , Day 7 and Day 28
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.	Day 0 (inclusion) , Day 7 and Day 28
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.	28 days
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.	28 days
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.	28 days
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.	28 days
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	28 days
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	28 days

Collaborators and Investigators

• Sponsor: Quanta Medical
• Collaborators: NAOS Institute of Life Science

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2018
• Primary Completion (Actual): August 1, 2018
• Study Completion (Actual): June 2, 2019

Study Registration Dates

• First Submitted: July 12, 2018
• First Submitted That Met QC Criteria: July 26, 2018
• First Posted (Actual): August 2, 2018

Study Record Updates

• Last Update Posted (Actual): September 6, 2019
• Last Update Submitted That Met QC Criteria: September 4, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Oncology; Hand Foot Syndrome Grade 2; Common Terminology Criteria for Adverse Events (CTCAE); Repair Cream; Cutaneous events; Palmar-plantar erythrodysesthesia syndrome; Targeted Therapies or Conventional Chemotherapy
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Pathologic Processes; Skin Diseases; Disease; Dermatitis; Drug-Related Side Effects and Adverse Reactions; Drug Eruptions; Drug Hypersensitivity; Syndrome; Hand-Foot Syndrome
• Other Study ID Numbers: NAOS_ONCOREPAIR_PP_17_2851

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No