A Phase 3 interventional study of Onco-Repair/ Placebo in Grade 2 Hand-foot Syndrom, sponsored by Quanta Medical. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-06.
Sponsored by Quanta Medical · Phase 3, Interventional, and Treatment
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.
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.
45 studies on the registry are indexed under Hand-Foot Syndrome; 9 are open to participants now.
This study's enrollment of 72 is above the median of 60 across 36 interventional studies indexed under Hand-Foot Syndrome.
Browse Hand-Foot Syndrome studies →Quanta Medical is the lead sponsor of 10 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Non-Inclusion Criteria:
Onco-Repair tube of 150 ml
Other: Onco-Repair/ 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.
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.
Time frame: 28 days
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 \[Visual analogue scale , 0 (no pain, no prurit) and 100 (worst possible pain or prurit)\]
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
1. = Very good tolerance: no functional signs of discomfort and no objective signs during examination 2. = Good tolerance: some functional signs of minimal and transient discomfort that did not interrupt the applications and no objective signs during examination 3. = Middle tolerance: functional signs of discomfort, net or persistent, or objective signs during examination that did not interrupt the applications of the investigationalproduct 4. = Poor tolerance: functional and / or objectives signs leading to discontinuation of the use of the investigational product
Time frame: 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
Time frame: 28 days
Plan to share: No
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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