Interest of a specific dermo-cosmetic product in the management of hand-foot syndrome induced by chemotherapies

Hand-foot syndrome (HFS) is the major adverse effect seen in patients undergoing anti-tumoral chemotherapies. HFS of any grade appears during the first 6 weeks of treatment on up to 71% of patients, and is characterized by dysesthesia, erythema, dryness, cracking, hyperkeratosis, pain, even ulceration, on palms, fingers, and soles. HFS can impair patients’ quality of life, but it is associated with patients’ treatment efficacy. The only effective method for HFS management is temporarily dose reduction or treatment discontinuation. Therefore, this study aims to evaluate the management of HFS with a specific dermo-cosmetic product in subjects treated by chemotherapies.

Firstly, to evaluate skin barrier function, the transepidermal water loss (TEWL) was measured on 12 subjects aged 24 to 60, with dry and disrupted skin (TEWL ≥ 9) after 28-days (D28) application. Secondly, a multicentric double-blind randomized clinical study was performed under oncological control where 42 patients (average age 62.7), starting an anti-tumoral treatment known to induce HFS, applied the product on the hands and feet at least once a day (or as often as necessary) for 56 days. The oncologists evaluated at each visit (D0, D14, D28, D42, D56):

• the time to onset, incidence and recovery time of HFS, whatever the grade according to the CTCAE V5.0;
• the time until modification of the antitumoral treatment and prescription of a treatment for HFS;
• the evolution of dermatological signs, dysesthesia and numbness rated on a 4-point scale;
• the evolution of pain and pruritus using a 100-point visual analogue scale declared by the patient;
• and the global efficacy of the product at D56.

In parallel, the patients assessed daily for 56 days their lesions, symptoms and safety of the product. They also filled the DLQI every 7 days and evaluated product’s efficacy at the end of the study.

At D28, the TEWL significantly decreased by -23% (p<0.05), demonstrating that the product improved skin barrier function. In the clinical study, grade 1 HFS occurred for 7 out of 42 patients who have applied the product, in average 27.9 ± 16.2 days after D0, with a completely recovery for 4 of them in average of 24.0 ± 9.5 days after inclusion. During the follow-up visits, investigators reported no evolution to a grade higher than 1 on these patients, as well as no modification of the anti-tumoral treatment, nor prescription of treatment due to HFS. No patient developed oedema, bleeding, blisters, hyperpigmentation, dysesthesia nor pain, but the 7 patients who developed HFS presented cracks/fissures (1 patient), desquamation/flaking (4), dryness (5), hyperkeratosis (3), numbness (3) and pruritus (7) with light intensity. The same symptoms were reported by the patients themselves. According to the investigators, the product was effective to very effective on 97.4 to 100% of the patients. The impact on quality of life among all patients remained stable (0.7/30) during the study period. Moreover, at D56, 97.4% of the patients considered that their skin was hydrated, soothed, comfortable, and smoothed. Finally, the product was very well tolerated by all patients.