Clinical trial · Interventional
Efficacy of the Cosmetic Product "Onco-Repair" on Grade 2 Hand Foot Syndrome
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.
NCT03612011CI-TRIAL-00040450OCRPcompletedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Grade 2 Hand-foot Syndrom | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Onco-Repair/ Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Onco-Repair
- description
- Onco-Repair tube of 150 ml
- interventionNames
- Other: Onco-Repair/ Placebo
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo tube of 150 ml
- interventionNames
- Other: Onco-Repair/ Placebo
Primary outcomes (1)
- measure
- Overall success
- timeFrame
- 28 days
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDLipworth 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
- BACKGROUNDZhang 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