DEXYANE MED

(1) Tolerance and efficacy study on eyelid eczema lesions, as monotherapy and in combination with treatments. METHODOLOGY: Open-label, non-comparative study of 55 adults with mild to severe eyelid eczema, divided into 2 groups: Group 1: subjects (33) with mild to moderate eczema without topical treatment and Group 2: subjects (22) with severe eczema with drug treatment Application of Dexyane Med Palpebral 2x/day for 3 weeks, alone (group1) or in combination (group2). PRIMARY CRITERIA: Evaluation of overall tolerance at D22 assessed by dermatologists (from 1 to 5) and by patients (from 0 to 9) in the 2 groups. SECONDARY CRITERIA OF TOLERANCE AND EFFICACY: Evaluation in monotherapy (group 1) at D1 (15 min after application), D3, D8, D15, and D22 of objective clinical signs (rated by the dermatologist from 0 to 4) and comparison before application; and subjective signs (rated by the patient from 0 to 9 according to intensity) and comparison with baseline values (B) observed on the 4 eyelids of each patient; evaluation of IGA and PGA scores (from 0 to 4 according to improvement) at D3,D8, D15, and D22. RESULTS: Objective visual signs* (%): Dryness: [B: 0(32); 1&2 (63); 3(5); 4(1)], [D1: 0 (87); 1to 2(13)], [D3: 0 (75); 1to 3 (25)]. Erythema: [B: 0(28); 1(43); 2(22); 3(6); 4(1)]; [J1: 0(30); 1(48); 2(14); 3(8)]; [J3: 0(79); 1(15); 2(3); 3(2)]. Desquamation: [B: 0(64); 1(28); 2(6); 3(2); 4(1)]; [J1: 0(90); 2(10)]; [J3: 0(94); 2(5); 3(2)]. Edema: [B: 0(58);1 (33); 2(8); 3(1); 4(1)]; [J1: 0(59); 1(34); 2(5); 3(2)], [J3: 0(97); 1&2(2); 3(1) i.e. -95% vs B] / Lichenification : [B: 0(36); 1(40); 2(18); 3(5)], [J1: 0(38); 1(41); 2(16); 3(5)], [J3: 0(51); 1(39); 2(5); 3(1)]. Subjective signs* (%): variation of the averages of the 4 scores obtained on the 4 eyelids compared to the initial score before application: Pruritus: B: 2; D1: 0,73 (-63%); D3: 0,41(-79%). Tingling: B: 1,2 ; D1: 0,57 (-53%); D3: 0,13( -89%). Pulling: B: 2.18; J1: 0.39 (-82%); J3: 0.52 (-76%). Burn: B: 1.25; D1: 0.83 (-33%); D3: 0.27 (-79% vs B*). IGA** score (%): D3: 3(75); 2(19); 1(3); 0(3) - D8: 4(26); 3(52); 2(19); 1(19); 0(3) - D15: 4(33); 3(47); 2(13); 1(3); 0(3) - D22: 4(45); 3(36); 2(6); 0(12). PGA** score (%): D3: 4(3); 3(72) i.e. 75% improved and cured; 2(16); 1(6); 0(3) - D8: 4(32); 3(42); 2(23); 0(3) - D15: 4(43); 3(37); 2(17); 0(3) - D22: 4(52); 3(30); 2(6); 0(12). *[Baseline=B, J1,J3]. ** 0: worsening, 1: no improvement; 2: slight improvement; 3: improvement; 4: cure (PFDC Study PRM03-F-197_V3_AN , 03/2019, 78-101, 98-108)

(2) Clinical study of safety and efficacy in combination with a medium-activity dermocorticoid and after discontinuation of treatment. Methodology: randomized, open-label, superiority, intraindividual study on 54 adults with atopic eczema on the arms and/or popliteal fossae (moderate to severe lesions), application of DexyaneMed twice daily in combination with a dermocorticoid on one limb versus dermocorticoid alone on the other limb, for 10 days. 
Main criterion: assessment of L-SCORAD change (from 0 to 18) at D1 and D3; Result: D1 (10.4 without DexyaneMed, 10.2 with DexyaneMed); D3 (8.9 versus 7.7), significant improvement.(RV4421A2013147; 04/03/2016; 91-92).