bisabolol and Dermatitis--Atopic

Atopic dermatitis (AD) is a very common chronic inflammatory and eczematous skin condition characterized by flares and remissions. Skin barrier alteration or dysfunction is the most relevant patogenetic factor. Topical corticosteroids are the mainstay treatment of AD, especially during flare periods. The daily use of emollients and moisturizers is also considered a relevant adjunctive strategy to improve skin barrier function and skin appearance in AD patients. Long-term use of topical corticosteroids is associated with important drawbacks and side effects. A corticosteroid-free cream containing starch, glycyrretinic acid, zinc oxide and bisabolol (Dermamid™; Difa Cooper, Caronno Pertusella, Varese, Italy) has been designed for the treatment of acute eczematous conditions like diaper dermatitis. However, this formulation could be particularly suitable also for AD. We evaluated in a three-center, assessor-blinded prospective 6-week treatment trial the efficacy and tolerability of this cream in children with chronic mild-to-moderate atopic dermatitis.. A total of 30 children (mean age 5 years, 18 males and 12 females) with chronic mild to moderate AD, affecting face, lower and upper limbs or trunk, were enrolled after parents' written informed consent. Exclusion criteria were a condition of immunosuppression, acute flares or a positive history of allergy to one of the components of the cream. The primary outcome was the evolution total eczema severity score (TESS) calculated as the sum of the single eczema severity score for each body area involved. Single area Eczema Severity Score (ESS) was calculated assessing eczema, infiltration, lichenification and scraching lesions using a 4-point scale grade (with 0=no sign, and 4=severe sign). A secondary endpoint was the percentage of subjects reaching at least 50% of TESS reduction at week 6 in comparison with baseline. The TESS was evaluated at baseline and after 3 and 6 weeks of treatment (twice daily application) in an assessor-blind fashion.. At baseline the mean (SD) TESS was 11.6 (4.7). TESS was reduced significantly (P=0.0001) to 5.7 (3) after 3 weeks (-51%), and to 3.0 (2.3) at week 6 (-74%). Similar reductions were observed for single area ESS values. The percentage of subjects with at least a >50% reduction of TESS value at the end of the study was 87%. The product was very well tolerated. Only for one patient a mild burning sensation at the application site was reported. All the subjects concluded the trial.. This trial supports the efficacy and the tolerability of a corticosteroid-free cream containing starch, glycyrretinic acid and bisabolol in the treatment of chronic mild to moderate atopic dermatitis in children.

Topics: Administration, Cutaneous; Anti-Inflammatory Agents; Child; Child, Preschool; Dermatitis, Atopic; Dermatologic Agents; Drug Combinations; Emollients; Female; Glycyrrhetinic Acid; Humans; Infant; Male; Monocyclic Sesquiterpenes; Prospective Studies; Sesquiterpenes; Severity of Illness Index; Skin Cream; Starch; Treatment Outcome; Zinc Oxide

The aim of the controlled double-blind trial was to demonstrate the superiority of a topical combination product over its single constituents.. A total of 278 patients with atopic dermatitis were randomized into four groups: 79 patients were treated with a topical combination of levomenol and heparin (A), 80 patients with levomenol alone (B), 78 patients with heparin alone (C) and 41 patients with the cream base with no active substances (D). The medication was applied twice daily for 8weeks. Efficacy criteria included the severity of pruritus (visual analogue scale, VAS) and the SCORing Atopic Dermatitis (SCORAD) index as well as the overall assessment of efficacy and tolerance by both physician and patient.. The improvement of pruritus and SCORAD values in Group A was significantly higher compared with Groups B-D (ancova, P<7×10(-8) ). The improvement of pruritus in Group A approximately corresponded to the cumulative effect of the two single active substances, with mean improvements of itching of -41.3, -13.3, -21.3 and +0.6mm VAS in Groups A-D, respectively (95% CI 7.1-13.5, 2.9-9.2 and 10.4-18.3mm for the comparisons A vs. B, A vs. C and A vs. D).. The combination of levomenol and heparin proved to be significantly more efficacious in the treatment of pruritus and inflamed skin than the preparations of the single components.

Topics: Administration, Cutaneous; Adolescent; Adult; Child; Child, Preschool; Dermatitis, Atopic; Double-Blind Method; Drug Combinations; Female; Fibrinolytic Agents; Heparin; Humans; Infant; Male; Middle Aged; Monocyclic Sesquiterpenes; Patient Satisfaction; Pruritus; Sesquiterpenes; Severity of Illness Index; Young Adult

Kamillosan(R) cream contains chamomile extract as active principle manufactured from the chamomile sort Manzana which is rich in active principles and has been proved not to exhibit a chamomile-related allergen potential. For this reason Kamillosan(R) cream is suited for local therapy of atopic eczema. In a partially double-blind, randomized study carried out as a half-side comparison, Kamillosan(R) cream was tested vs. 0.5% hydrocortisone cream and the vehicle cream as placebo in patients suffering from medium-degree atopic eczema. After a 2-week treatment Kamillosan(R) cream showed a mild superiority towards 0.5% hydrocortisone and a marginal difference as compared to placebo.

Topics: Administration, Topical; Anti-Inflammatory Agents; Arachidonic Acid; Arm; Chamomile; Dermatitis, Atopic; Drug Combinations; Erythema; Humans; Hydrocortisone; Middle Aged; Oils, Volatile; Phytotherapy; Plant Extracts; Plants, Medicinal; Pruritus; Sesquiterpenes; Treatment Outcome

Topics: Animals; Anti-Inflammatory Agents; Cytokines; Dermatitis, Atopic; Dinitrochlorobenzene; Mast Cells; Mice; Mice, Inbred BALB C; Monocyclic Sesquiterpenes; NF-kappa B; Skin; Tumor Necrosis Factor-alpha