DUCRAY DEXYANE MED PALPEBRAL FOR THE EYELIDS 15ML
Treatment against eyelid eczema
Indications:
The only medical device that treats contact or atopic eyelid eczema
Properties:
It heals and reduces the recurrence of eczema lesions. Proven tolerance in the treatment of mild to severe inflammatory lesions. Its texture is pleasant, spreads easily, is extremely moisturizing and non-sticky. Skin with eczematous lesions regains elasticity and comfort. Clinically proven tolerance. Contains no cortisone, no fragrance, tested for nickel. Suitable for use from 3 months and above.
Instructions for use :
Apply a thin layer directly to the inflamed lesions of mobile eyelid eczema with a clean finger, avoiding any contact with the eye. It is used alone or in combination with topical corticosteroids. 1 to 2 times a day. External use. Do not use if you are allergic to any of the ingredients. In case of allergic reaction consult a doctor. In the absence of data, not to be used by pregnant or lactating women. Keep away from children. Avoid any direct contact with eyes. Close the tube tightly after use. Do not use the product if the tube is damaged. In case of adverse reactions related to the use of the products, consult a doctor.
Proven effectiveness:
Good to excellent tolerance alone or in combination in lesions, in 82% of patients(1) IN COMBINATION Accelerates lesion healing from day 3(2) IN THE MAINTENANCE PHASE, alone Limits recurrence of lesions(2) AGGRESSIVE ACTION IN DEPTH From 1st application -63% of itching(1) -79% of burning sensation after 3 days(1) (1) Clinical study of tolerance and effectiveness in eczema lesions of the eyelids, alone and in combination with medicinal treatments. METHODOLOGY: open-label, non-comparative study in 55 adults with mild to severe eyelid eczema, divided into 2 groups: Group 1: (33) patients with mild to severe eyelid eczema without topical treatment and Group 2: (22) patients with eczema severe form that apply medication (dermocorticoids or calcineurin inhibitors). Application of DEXYANE MeD PALPÉBRAL 2x/day for 3 weeks, alone (group 1) or in combination (group 2), MAIN CRITERIA: Assessment of overall tolerance on H22 by dermatologists (from 1 to 5) and by patients (from 0 to 9) in both groups. SECONDARY TERMS OF TOLERANCE AND EFFICACY: Efficacy: Evaluation as monotherapy (group 1) at H1 (15 minutes after application), H3, H8, H15 and H22 of objective clinical signs (dermatologist score from 0 to 4) compared to before the application and subjective signs (patient score from 0 to 9 depending on the intensity) compared to the reference values observed in the 4 eyelids of each patient. Evaluation of IGA and PGA score (or results) (from 0 to 4 depending on improvement) on H3, H8, H15 and H22. Results: Visual Objective Points * (%): Dryness: [B: 0 (32); 1 & 2 (63). 3 (5); 4 (1)], [H1: 0 (87). 1 to 2 (13)], [H3: 0 (75). 1 to 3 (25)]. Erythema: [B: 0 (28); 1 (43); 2 (22); 3 (6); 4 (1)]; [H1: 0 (30); 1 (48); 2 (14); 3 (8)]; [H3: 0 (79); 1 (15); 2 (3); 3 (2)]. Scaling: [B: 0 (64); 1 (28); 2 (6); 3 (2); 4 (1)]. [H1: 0 (90); 2 (10)]; [H3: 0 (94); 2 (5); 3 (2)]. Edema: [B: 0 (58); 1 (33); 2 (8); 3 (1); 4 (1)]; [H1: 0 (59); 1 (34). 2 (5). 3 (2)], [H3: 0 (97; 1 & 2 (2); 3 (1) -95% vs. reference value] / lichenification: [B: 0 (36); 1 (40); 2 ( 18); 3 (5)], [H1: 0 (38). 1 (41); 2 (16); 3 (5)], [H3: 0 (51). 1 (39); 2 (5); 3 (1)]. Subjective points * (%): change in the average of the 4 scores obtained from the 4 eyelids compared to the initial score before application: Itching: B: 2; H1: 0.73 (-63%). H3: 0,41 (-79%). Numbness: B: 1,2; H1: 0,57 (-53%). H3: 0.13 (-89%) Pull: B: 2.18; H1: 0,39 (-82%). H3: 0,52 (-76%). Burning sensation: B: 1,25; H1: 0,83 (-33%). H3: 0,27 (-79% vs. B *). The IGA score ** (%): H3: 3 (75). 2 (19). 1 (3); 0 (3) - H8: 4 (26), 3 (52). 2 (19); 1 (19); 0 (3) - H15: 4 (33). 3 (47); 2 (13); 1 (3); 0 (3) - H22: 4 (45). 3 (36); 2 (6); 0 (12). PGA result ** (%): H3: 4 (3); 3 (72) 75% improved and healed. 2 (16); 1 (6); 0 (3) - H8: 4 (32). 3 DEXYANE MeD and DEXYANE MeD PALPÉBRAL (42); 2 (23); 0 (3) - H15: 4 (43). 3 (37); 2 (17); 0 (3) -H22: 4 (52). 3 (30); 2 (6); 0 (12). * [Reference value = B, H1, H3]. ** 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) Instruction Sheet of DEXYANE MeD Palpebral (3) Clinical study of tolerability and efficacy in combination with a topical corticosteroid of intermediate potency and after discontinuation of treatment. (a) METHODOLOGY: randomized open-label, intra-subject, study, in 54 adults presenting with atopic eczema in the area of the arms and/or in internal cavities (moderate to severe lesions), applying Dexyane Med 2 times/day in combination with a topical corticosteroid on one limb compared to topical corticosteroid monotherapy on another limb, for 10 days. Main criteria: assessment of L-SCORAD differentiation at H1 and H3. Results: 10,4 without Dexyane Med; 10,2 with Dexyane Med) and H3 (8,9 vs. 7,7). (PFDC Study, RV4421A2013147, 04/03/2016, 91-92). (4) Clinical study of tolerance and efficacy. METHODOLOGY: open study in 40 adults with chronic hand eczema (mild to moderate lesions), applying Dexyane Med 2 times/day to the affected area for 22 days. MAIN CRITERIA: Investigator assessment of local tolerance (sides 1 to 5) at H22. MAIN TOLERANCE CRITERIA (a): Assessment of local tolerance (sides 1 to 5) at H22, by the investigator. SECONDARY EFFICACY MEASURES (b): Investigator-rated efficacy on a 0-to-21 scale of clinical severity total score (mTLSS) at H1, H8 and H22. (c) Patient's rating of itch intensity PGA (from 0 to 10) at H1, H8, H15 and H22. (d) Self-rating of PGA pain intensity (scale from 0 to 10) on H1, H8, H15 and H22. Results: (a) Excellent tolerance 28 (70%). very good 7 (17,5%). good 5 (12,5%). (b) mTLSS result in H1: 8,3; H8: 4,4 (-47%). (c) itching on H1: 5,1. H8: 2,2 (-58%). H15: 1,5 (-71%). H22: 1,5 (-70%); (d) Pain on H1: 4,2. H8: 1,2 (-73%). H15: 0,8 (-81%). H22:0,9 (-78%) (PFDC Study, RV4421A2013149 - 29/02/2016; 110-113, 142).
Composition :
WATER (AQUA). GLYCERIN. CAPRYLIC / CAPRIC TRIGLYCERIDE. BUTYLENE GLYCOL. POLYSORBATE 60. BUTYROSPERMUM PARKII (SHEA) BUTTER (BUTYROSPERMUM PARKII BUTTER). PROPYLENE GLYCOL. BEESWAX (CERA ALBA). GLYCERYL STEARATE. PEG-100 STEARATE. 10-HYDROXYDECENOIC ACID. CAPRYLYL GLYCOL. CETYL ALCOHOL. DISODIUM EDTA. GLYCYRRHETINIC ACID. POLYACRYLATE-13. POLYISOBUTENE. POLYSORBATE 20. SCLEROTIUM GUM. SORBITAN ISOSTEARATE. CITRIC ACID.
Packing: Tube 15ml
EAN: 3282770148046
