Single application of lamellar moisturizers provides significantly increased hydration of the stratum corneum for up to 24 hours in a randomized trial.

BACKGROUND: Some moisturizing formulations can help restore and maintain the barrier function of the skin. OBJECTIVES: This study was designed to assess the hydration potential of three lamellar moisturizers relative to a control (nonlamellar) moisturizer. METHODS: Healthy adults aged 18 to 65 years with self-reported sensitive skin, dry or very dry skin and Corneometry values of ≤40 a.u. on the lower legs, entered this randomized, evaluator-blind study. Products A and B together with a control product (Control X) were applied to one leg, while Product C and Control Y were applied to the other leg; with an untreated control site in both cases. The primary efficacy variable was the change from baseline in Corneometer assessments at 24 hours (Products A and B) or 12 hours (Product C) postapplication. RESULTS: At all timepoints (n = 30), Products A and B showed higher mean Corneometer readings compared to baseline and changes from baseline were statistically significant when compared to untreated sites. Higher mean readings relative to baseline were seen at sites treated with Control X (smaller magnitude than Product A and B) and with Product C. These changes were significant compared to the untreated site at 30 minutes and 2 hours (Control X), and at 30 minutes and 12 hours (Product C). Additionally, Control Y increased significantly at 12 hours. CONCLUSION: A single application of a lamellar moisturizer significantly increased hydration of the stratum corneum for up to 24 hours (Products A and B) or 12 hours (Product C).

Absence of human skin irritation and allergenic potential after repeated patch applications of a lamellar moisturizer.

BACKGROUND: New cosmetic products should undergo clinical evaluation for skin sensitization potential. OBJECTIVES: To assess the irritation and sensitization potential of a moisturizer containing lamellar structured lipids after repeated patch application in humans, using human repeated insult patch test methodology. METHODS: This 6-week, single-center, open-label study compared a lamellar moisturizer with negative saline control in human subjects aged 18-70 years and skin phototype (Fitzpatrick) classification I-IV. During an initial induction phase, semi-occlusive multi-test patches were applied to the skin of participants' backs three times per week for 3 consecutive weeks; clinical assessments were performed per International Contact Dermatitis Research Group criteria. Participants subsequently underwent a challenge phase, where a new patch was applied to a contact-naïve area of the skin to assess sensitization to the moisturizer. RESULTS: The study commenced with 233 voluntary participants, 214 of whom completed the study and underwent the final dermatological assessment. Most participants (232/233; 99.6%) demonstrated negative patch test results. One participant had a positive reaction at the lamellar moisturizer application site, with visible erythema and edema (classified as an adverse event [AE]); however, this reaction was observed 24 hours after a reaction to another product in the patch test panel (a prototype cleanser). Importantly, no skin reactions were detected during the challenge phase. Two participants had AEs of mild contact dermatitis in the area of patch adhesive application during the induction phase. No serious AEs occurred during the study. CONCLUSIONS: These findings suggest that the lamellar moisturizer has low irritant and allergenic potential.

Skin acceptability of a cosmetic moisturizer formulation in female subjects with sensitive skin.

PURPOSE: This 3-week, open-label, noncomparative clinical study evaluated the skin acceptability of a cosmetic moisturizer in subjects with sensitive skin, by monitoring adverse events (AEs) and cutaneous discomfort related to normal usage. MATERIALS AND METHODS: Female subjects aged between 18-60 years, with Fitzpatrick phototype classification I-IV and sensitive skin, verified by a positive reaction on the stinging test at screening, were included. Subjects applied the moisturizer to their face and body twice daily for 21±2 days at home and recorded study product usage and feelings of cutaneous discomfort (eg, dryness, prickling, stinging, and itching) in a diary; any AEs were reported to the clinic. At study end, skin acceptability of the moisturizer was investigator-assessed based on the nature of AEs and subjects' self-reported feelings of discomfort, and by clinical evaluation of skin reactions in the area of moisturizer application (appearance of erythema, formation of edema, and skin desquamation; scored according to an adapted Draize and Kligman scale). Only subjects with a treatment compliance of ≥80% were included in the final analysis. RESULTS: In total, 35 subjects initiated and completed the study; all were compliant to the minimum study product usage. Per investigator clinical dermatological assessment at study end, none of the 35 subjects had skin reactions in the area of moisturizer application and there were no reported AEs. One subject reported sensations of mild prickling and itching immediately after applying the moisturizer (not classified as AEs), which spontaneously remitted after complete absorption of the product and were noted only in exposed areas. These events were considered by the investigator as being possibly/probably related to the use of study product; however, no clinical signs of skin reaction were observed in the exposed areas. CONCLUSION: This cosmetic moisturizer appears generally well tolerated and suitable for topical use in subjects with sensitive skin.

A Prototype Lip Balm: Summary of Three Dermatological Studies Demonstrating Safety and Acceptability for Sensitive Skin.

Data were generated from three studies to assess the tolerability and acceptability of a prototype cosmetic lip balm. Dermatological assessments of topical compatibility (primary and cumulative irritability and sensitization), photoirritant and topical photosensitizer potential, and acceptability for safe use of a prototype cosmetic lip balm on sensitive skin are summarized. In Study 1, the product was applied to the volunteers' backs under a semiocclusive patch followed by patch removal/reapplication over 6 weeks to assess the irritant and allergic potential of the product. Dermatological assessments were performed at the beginning and end of the study or when there was evidence of positivity or adverse event. Study 2 was conducted by applying the product to the volunteers' backs under a semiocclusive patch, followed by patch removal/reapplication and irradiation of the test area with ultraviolet A (UVA) radiation at various intervals over 5 weeks. Dermatological assessments were performed to assess the product's role in the induction of photoirritancy and photosensitization. Clinical and subjective assessments for acceptability were obtained during Study 3 in volunteers with a diagnosis of sensitive skin and those who used the product as per instructions for use during the study period. The data generated from the three studies demonstrated no evidence of primary or cumulative dermal irritation or of dermal sensitization. In addition, no photoirritation potential or photosensitization potential was observed. As assessed by dermatologic monitoring and subject diary entries, the prototype lip balm did not cause irritation or sensitization reactions when used for 28 days in volunteers with a diagnosis of sensitive skin. Based on these findings, the prototype lip balm can be considered suitable for use for people with sensitive skin.

A randomised clinical trial to assess control of oral malodour by a novel dentifrice containing 0.1%w/w o-cymen-5-ol, 0.6%w/w zinc chloride.

OBJECTIVES: To assess the ability of a 0.1% w/w o-cymen-5-ol/ 0.6% w/w zinc chloride/ sodium fluoride dentifrice to control oral malodour compared to a sodium fluoride control dentifrice. DESIGN: Following baseline measurement of oral volatile sulfur compounds (VSCs), the subjects brushed twice daily for 1 week with either the test or control dentifrice. The VSC concentration in breath samples was monitored up to 12 hours post-treatment, by gas chromatography (GC). RESULTS: 75 subjects were included in the efficacy analysis. Relative to the sodium fluoride control dentifrice group the o-cymen-5-ol/ zinc chloride/ sodium fluoride dentifrice exhibited statistically significant reductions (P<0.0001) in hydrogen sulfide, methyl mercaptan and total measured VSCs immediately and after 1, 2, 3 and 12 (overnight) hours post-treatment. CONCLUSION: The results of the present clinical study demonstrated that the use of the 0.1% w/w o-cymen-5-ol/ 0.6% w/w zinc chloride/ sodium fluoride dentifrice over a one week period provided a statistically significant benefit in controlling oral malodour for up to 12 hours post-treatment compared to a sodium fluoride control dentifrice.