An Open-Label, Intra-Individual Study to Evaluate a Regimen of Three Cosmetic Products Combined with Medical Treatment of Rosacea: Cutaneous Tolerability and Effect on Hydration.

INTRODUCTION: Although rosacea management includes general skincare, previous studies have not evaluated comprehensive skincare regimens as adjuvants to other treatments. METHODS: The primary objective of this open-label, intra-individual study of subjects with rosacea was to evaluate the cutaneous tolerability of a regimen consisting of Cetaphil PRO Redness Control Day Moisturizing Cream (once daily in the morning), Cetaphil PRO Redness Control Night Repair Cream (once daily in the evening) and Cetaphil PRO Redness Control Facial Wash (foam once in the morning and once in the evening). Secondary objectives were to evaluate the effect on transepidermal water loss (TEWL) and cutaneous hydration and to determine the subjects' evaluation of efficacy, tolerability and future use. A dermatologist examined subjects and measured TEWL and cutaneous hydration on day (D) 0, D7 and D21, when subjects ranked symptoms. Subjects completed a questionnaire on D21. RESULTS: The per-protocol population consisted of 42 subjects receiving treatment for rosacea. Eleven subjects developed adverse events, none of which were considered to be related to the skincare products. Five subjects showed signs or symptoms that were potentially associated with the skincare products that might suggest poor cutaneous tolerability; these were generally mild. TEWL decreased significantly by a mean of 17% on D7 and a mean of 28% on D21 compared with baseline (both P < 0.001). Skin hydration increased significantly by a mean of 5% on D7 (P = 0.008) and a mean of 10% on D21 (P < 0.001) compared with baseline. Subjects reported that the regimen was pleasant (98%) and effective (95%) and that it offered various benefits; 90% of subjects reported that they would like to continue to use the regimen and would buy the products. CONCLUSION: The skincare regimen improved skin hydration and skin barrier function in subjects receiving medical treatment for rosacea and was well tolerated. FUNDING: Galderma S.A.

A novel moisturizer with high sun protection factor improves cutaneous barrier function and the visible appearance of rosacea-prone skin.

BACKGROUND: Consensus guidelines advocate general skincare for rosacea patients. OBJECTIVES: Two independent studies were performed to assess whether a tinted daily SPF-30 facial moisturizer (DFM30) improves barrier function of dry skin and the efficacy and tolerability of DFM30 on rosacea-prone skin. METHODS: In study 1, electrical capacitance (EC) and transepidermal water loss (TEWL) were measured at baseline, 2, 4, 8, and 24 hours after a single application of DFM30 and on a control site in 21 healthy females with dry skin. Study 2 evaluated 33 females with mild to moderate rosacea and nontransient erythema. Efficacy and tolerability after once-daily DFM30 were assessed using a chromameter, image analysis of photographs, and trained rater and patient evaluations up to day 22. RESULTS: In study 1, EC showed statistically significant increases at 2, 4, and 8 hours, and TEWL showed statistically significant decreases 2, 4, 8, and 24 hours after DFM30 application to healthy females compared to baseline. In study 2, covering skin redness improved significantly after DFM30 application on day 1; 33.3% showed improved covering skin redness compared to baseline. Patients reported significantly less redness on day 8 than day 3. Feelings of dryness and tightness/tension were lower 30 minutes after first application. Feeling of dryness was lower than baseline after 3 days, 1 and 3 weeks. Image analysis suggested redness was significantly lower on day 22 compared to baseline. Chromameter readings showed significantly lower erythema on the cheek compared to baseline. All patients stated that DFM30 relieves and neutralizes visible redness who also indicated that they would purchase DFM30, and the product was well tolerated. CONCLUSIONS: These studies show that DFM30 is suitable as part of the skincare regimens advocated by ROSacea COnsensus (ROSCO) for rosacea patients. DFM30 is an effective moisturizer that improves cutaneous barrier function and the appearance of rosacea-prone skin.

A Novel Night Moisturizer Enhances Cutaneous Barrier Function in Dry Skin and Improves Dermatological Outcomes in Rosacea-prone Skin.

Objective: We assessed whether Cetaphil Redness Control Night Cream (CRCNC; Galderma Laboratories, Fort Worth, Texas) improves electrical capacitance (EC) and transepidermal water loss (TEWL) in healthy subjects with dry skin and determined efficacy and tolerability in subjects with rosacea. Study design: The present study included two independent, open-label investigations: in the first, EC and TEWL were measured at baseline and at two, four, eight, and 24 hours after one application of CRCNC to dry skin; in the second, an evaluation of once-daily CRCNC application for 22 days using a chromameter, image analysis, and trained rater was performed, with patient evaluations at baseline and Days 1, 8, and 22 collected. The first study enrolled 20 subjects (13 women; mean age: 45 years). The second study enrolled 33 women (mean age: 54 years), with 30 having sensitive skin. Results: EC increased significantly at two (by 67.0%), four (60.2%), eight (52.1%), and 24 (17.9%) hours after CRCNC application. TEWL was reduced significantly at two (18.0%), four (14.3%), and eight (18.2%) hours after application. Additionally, improvements in redness were seen at Days 8 (24.2%; p=0.008) and 22 (27.3%; p=0.004). Versus baseline, 21.2% (p=0.07), 39.4% (p<0.001), and 48.5% (p<0.001) of subjects reported improvements at 30 minutes after application and on Days 8 and 22, respectively. Conclusions: CRCNC is an effective and well-tolerated moisturizer that improves cutaneous barrier function in subjects with dry skin and in those subjects with sensitive skin and type 1 rosacea.

Evaluation of a novel very high sun-protection-factor moisturizer in adults with rosacea-prone sensitive skin.

BACKGROUND/OBJECTIVE: Rosacea-prone sensitive skin requires high sun-protection factor (SPF) moisturizers. This study evaluated Daylong Extreme SPF 50+ lotion, a novel cream containing five ultraviolet filters, two emollients, and three skin conditioners. SUBJECTS AND METHODS: This was an open-label, single-center study. On day 1, before treatment, subjects answered a questionnaire on their skin conditions and sunscreen habits, and both subjects and dermatologist evaluated skin status. Subjects applied the product once daily in the morning to the face for 21 days, and after approximately 3-5 minutes they assessed tolerability and short-term cosmetic acceptability in a questionnaire and daily diary. On day 22, the dermatologist and subjects evaluated skin status for long-term tolerance and cosmetic acceptability. RESULTS: The study enrolled 44 individuals (mean age 58.8 years, 91% female). At baseline, most subjects (39 of 44) showed erythema, and ~30% showed dryness and scaling. Dermatologists noted four cases of pustules and one case of papules. After 21 days' treatment with the product, the dermatologist reported significantly less erythema, dryness and scaling, three cases of pustules and two cases of papules. At baseline, ~75% of subjects noted a feeling of dryness, >50% reported tension, and nearly 25% reported tickling. After using the product for 21 days, subjects reported significantly less tension, dryness, and tickling. Some subjects noted itching and burning before and after using the product. One subject noted papules during treatment. Most subjects said that the product was pleasant, did not irritate the skin or cause stinging/burning, was easy to apply, quickly absorbed, and nongreasy, improved skin moisturization, helped prevent sun-provoked facial redness, did not worsen rosacea, and was easily incorporated into their skincare regimen. Half would switch to the product, and 80% of subjects would buy and recommend the product. CONCLUSION: The product was well tolerated in rosacea-prone subjects, producing objective and subjective improvements in skin status and symptoms.

Influence of progressive fluid restriction on mood and physiological markers of dehydration in women.

The present study evaluated, using a well-controlled dehydration protocol, the effects of 24 h fluid deprivation (FD) on selected mood and physiological parameters. In the present cross-over study, twenty healthy women (age 25 (SE 0.78) years) participated in two randomised sessions: FD-induced dehydration v. a fully hydrated control condition. In the FD period, the last water intake was between 18.00 and 19.00 hours and no beverages were allowed until 18.00 hours on the next day (23-24 h). Water intake was only permitted at fixed periods during the control condition. Physiological parameters in the urine, blood and saliva (osmolality) as well as mood and sensations (headache and thirst) were compared across the experimental conditions. Safety was monitored throughout the study. The FD protocol was effective as indicated by a significant reduction in urine output. No clinical abnormalities of biological parameters or vital signs were observed, although heart rate was increased by FD. Increased urine specific gravity, darker urine colour and increased thirst were early markers of dehydration. Interestingly, dehydration also induced a significant increase in saliva osmolality at the end of the 24 h FD period but plasma osmolality remained unchanged. The significant effects of FD on mood included decreased alertness and increased sleepiness, fatigue and confusion. The most consistent effects of mild dehydration on mood are on sleep/wake parameters. Urine specific gravity appears to be the best physiological measure of hydration status in subjects with a normal level of activity; saliva osmolality is another reliable and non-invasive method for assessing hydration status.