stearates and Dermatitis--Contact

An improved human model for the quantification of skin barrier creams (BCs) is described. In contrast to the previously published procedure, the back, instead of the forearm, and a total of 4 irritants are used. Due to the larger area, 3 BC formulations can be simultaneously compared to the control field, which receives the irritant only, without BC-pretreatment. On 10 human volunteers, the irritants 10% sodium lauryl sulfate (SLS), 1% sodium hydroxide (NaOH), 30% lactic acid (LA) and undiluted toluene (TOL) were applied via large Finn Chambers for 30 min, 5 x during the 1st week and 4 x during the 2nd week. Taktosan Salbe (water-in-oil emulsion) and RAWI Speerschutzcreme (oil-in-water emulsion) were applied 30 min before contact with the irritants. In order to assess reproducibility and interindividual variation, the BC RAWI was tested in duplicate. Irritant cutaneous reactions were quantified by 4 parameters: erythema score, transepidermal water loss, blood flow volume and stratum corneum hydration by measuring capacitance. The results showed marked differences in efficacy. Taktosan significantly suppressed irritation by SLS, NaOH and LA, which was apparent in nearly all parameters. RAWI caused significant inhibition of SLS irritation, and a positive trend against NaOH and LA was observed. Both BCs failed against TOL. The results of duplicate testing with RAWI showed good reproducibility. The dogma that oil-in-water emulsions are primarily effective against lipophilic irritants, and water-in-oil emulsions against hydrophilic irritants, needs to be re-evaluated on the basis of our findings. This model seems to have potential for further studies on BCs and might elucidate the complex interaction of BCs with irritants.

Topics: Adult; Benzenesulfonates; Dermatitis, Contact; Dermatitis, Irritant; Dermatologic Agents; Emulsions; Female; Humans; Irritants; Male; Middle Aged; Ointments; Reproducibility of Results; Skin Tests; Stearates

COR806.805 (Tetrix Cream) is a new barrier cream formulated using a unique patented technology. As a water-in-oil emulsion, COR806.805 has a water-resistant outer surface and water-soluble inner surface. Clinical studies have demonstrated the safety of COR806.805 in healthy adults with respect to sensitization, irritation, and effect on the healing of existing skin lesions. We report the results of trials undertaken to explore the substantivity and barrier protection properties of this new product when applied to clinically normal skin, as well as the beneficial effects when applied to inflamed skin, including skin affected by eczema. The results indicate that the cream establishes a barrier against common irritants, with persistence over 6 hours. The product appears effective and well-tolerated as a barrier and also may provide benefit in managing the itching and burning associated with contact dermatitis.

Topics: Adult; Allergens; Aluminum Hydroxide; Clinical Trials as Topic; Dermatitis, Contact; Dermatologic Agents; Emollients; Female; Hand Dermatoses; Humans; Magnesium Hydroxide; Siloxanes; Stearates

Patients with contact dermatitis require both preventive and therapeutic interventions to minimize their burden of disease. The ideal product would support resolution of inflamed skin without the use of glucocorticoids while protecting undamaged skin against further contact with irritants and antigens. COR806.805 (Tetrix Cream) is a novel barrier cream formulated for use on both lesional and nonlesional skin. Three clinical trials were conducted to evaluate the safety of this new product by studying sensitization, cumulative irritation, and effect on healing; a combined total of 265 participants completed the studies (210, 45, and 10, respectively), with no serious adverse events considered to be related to the product. Six mild adverse events were considered related or potentially related. As tested, COR806.805 is neither sensitizing nor irritating when applied to intact or lesional skin. Testing indicates that COR806.805 does not inhibit healing of allergic contact dermatitis lesions.

Topics: Adult; Allergens; Aluminum Hydroxide; Clinical Trials as Topic; Dermatitis, Contact; Dermatologic Agents; Emollients; Female; Hand Dermatoses; Humans; Magnesium Hydroxide; Siloxanes; Stearates

As a follow-up of a preliminary trial, the therapeutic results obtained in 40 cases of acute and chronic dermatitis by the topical application of 10-undecen-1-yl-pseudothiourea hydroiodide (AHR-1911) in an evanescent vehicle containing triethanolamine stearate are presented. The treatment led to complete remission in 14/40 and to favorable results in 18/40 cases. In 2 out of 3 cases of infantile atopic dermatitis improvement was followed by relapse. The responsiveness to AHR-1911 of patients with delayed hypersensitivity, which requires steroids for treatment, is considered of clinical importance. The prompt action of the drug in acute dermatitis, such as is produced by insect-bites, appeared to be impressive. None of the total of 50 cases treated by the author with this new preparation showed any manifestation of intolerance or reaction to the drug.

Topics: Acute Disease; Administration, Topical; Adult; Anti-Inflammatory Agents; Child; Chronic Disease; Dermatitis; Dermatitis, Contact; Drug Evaluation; Ethanolamines; Humans; Infant; Insect Bites and Stings; Isothiuronium; Pharmaceutical Vehicles; Stearates; Thiourea

Topics: Deodorants; Dermatitis, Allergic Contact; Dermatitis, Contact; Glycerides; Humans; Nervous System Physiological Phenomena; Stearates