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

NCT03612011 | Completed Phase 3

• 1 other identifier: NAOS_ONCOREPAIR_PP_17_2851
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• 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

  28 days

• Clinical parameters such as lesion color

  Day 0 (inclusion) , Day 7 and Day 28

• Clinical parameters such as presence of blisters

  Day 0 (inclusion) , Day 7 and Day 28

• Clinical parameters such as fissures/cracks

  Day 0 (inclusion) , Day 7 and Day 28

• Assessment of quality of life from D0 to D28 using Dermatology Life Quality Index scale

  28 days

Study Arms (2)

Onco-Repair

EXPERIMENTAL

Onco-Repair tube of 150 ml

Other: Onco-Repair/ Placebo

Placebo

PLACEBO COMPARATOR

Placebo tube of 150 ml

Other: Onco-Repair/ Placebo

Interventions

Onco-Repair/ Placebo OTHER

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.

Onco-Repair; Placebo

Eligibility Criteria

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

You may qualify if:

• 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
• 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

Sponsors & Collaborators

• Quanta Medical: lead
• NAOS Institute of Life Science: collaborator

Study Sites (1)

Quanta Medical

Rueil-Malmaison, 92500, France

Location

Related Publications (2)

• 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.

  PMID: 19923864 BACKGROUND

• 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.

  PMID: 21113620 BACKGROUND

MeSH Terms

Conditions

Neoplasms; Hand-Foot Syndrome

Condition Hierarchy (Ancestors)

Drug Eruptions; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Drug Hypersensitivity; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Cosmetic product "Onco-Repair" and placebo will be filled in the tubes with same appearance and smell. The tubes will be marked anonymusioly
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: July 12, 2018
• First Posted: August 2, 2018
• Study Start: July 12, 2018
• Primary Completion: August 1, 2018
• Study Completion: June 2, 2019
• Last Updated: September 6, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)