Photo Visualization of Skintone Compatibility of an SPF 35 Sunscreen.

BACKGROUND: Visual casts and discoloration are common barriers to sunscreen use in melanin-rich populations. However, photoprotective measures are essential for individuals with all skin types, including darker skin. METHODS: Single-center, 7-day, open-label study of healthy adult females with Fitzpatrick Skin Types (FST) IV to VI and sensitive skin treated with once-daily daily facial moisturizer sun protection factor 35 (DFM SPF35). Subjects completed a cosmetic acceptability questionnaire at days 1 and 7. Photography using VISIA CR was performed at day 7. Adverse events were monitored throughout the study. RESULTS: Thirty-two (32) subjects participated; 31.3% had FST IV, 53.1% V, and 15.6% VI skin. DFM SPF35 was viewed as cosmetically elegant. At day 1, 96.7% of subjects agreed product was easy to apply; 90.0% reported soft skin after product use; 86.7% said it had a lightweight, non-greasy feel and hydrated the skin. At day 7, 93.7% reported no visible white residue on their skin and said the product applied easily/absorbed well. The majority (90.6%) would continue using and would recommend the product; and 87.5% reported the product blended seamlessly into their skin, which agreed with clinical photography. Responses were consistent among subjects with normal, oily, or combination skin. No adverse events were reported. CONCLUSIONS: DFM SPF35 blended well into the skin and was perceived favorably among subjects with SOC after 1 and 7 days of use. Subjects felt it had good cosmetic acceptability without unacceptable white residues or a greasy feeling. Dermatologists need to be versed in products that can be used on a variety of skin types.J Drugs Dermatol. 2024;23(7):515-518.  doi:10.36849/JDD.8223.

Heatmap Evaluation of Facial Hydration Using a Novel Python Program.

BACKGROUND: Evaluating cleansers and moisturizers provides important information to guide clinicians in the recommendation of these products. This project was performed to visualize skin hydration via heatmap after the use of a gentle skin cleanser (GSC) and moisturizing lotion (ML). METHODS: Half-face, intra-individual open-label study in healthy volunteers. Cleanser was administered in a single application that was then wiped off the face. Moisturizing lotion was applied at least once-daily for one week. Hydration measurements were made at 30 pre-defined points on half of the face, at baseline, and 30 minutes post-application; an additional assessment at week 1 was made for the moisturizing lotion. Heatmaps were generated using Python programming software to interpolate hydration values to colors that were then superimposed onto the volunteer's facial image.  Results: Five subjects completed the cleanser assessments, and 5 subjects completed the 30-minute evaluation for the lotion, with 4 completing the week 1 assessment. There was a visible shift in skin hydration post-GSC application from values approximately in the 12-42 AU (arbitrary unit) range to 30-60 AU at 30 minutes. Similarly, there was a shift in hydration from baseline to 30 minutes that continued to increase through week 1 of ML use. CONCLUSIONS: This innovative heatmap data generation showed a clear, visual change in hydration over time. There was a visible shift in hydration values from baseline to 30 minutes after application of cleanser; hydration also improved after use of moisturizing lotion at 30 minutes and increased after week 1 application.  J Drugs Dermatol. 2024;23(6):463-465.     doi:10.36849/JDD.8221.

An Over-the-Counter Healing Ointment: Benefits in Dry Skin and Wound Healing.

BACKGROUND: The use of ointments can be beneficial for dry, chapped, or cracked skin and also for supporting wound healing. We describe the results of 2 studies with an over-the-counter healing ointment (HO) to evaluate the effects on skin hydration and in the setting of wound healing after dermatologic procedures.  Methods: Study 1 was a single-center, in-use study using HO on qualified areas at least once daily for 4 weeks in subjects with dry, cracked body skin and self-perceived sensitive skin. Study 2 was a multi-center study of wound healing in subjects using HO on a daily basis after having dermatologic surgical procedures.  Results: In Study 1, there was a significant reduction in skin dryness after 1 and 4 weeks of HO use (P<0.05). Image analysis of the skin revealed a significant increase in skin smoothness after the first application of HO in 100% of subjects (P<0.05). Tolerability and safety were excellent, and HO was well-perceived by subjects throughout the study. In Study 2, HO improved clinical assessments at all time points compared with baseline with a decrease in erythema, edema, scabbing/crusting, and an improvement in overall wound appearance (P<0.05). There was no worsening or significant increase in measures for tolerability parameters at any study visits. Additionally, HO achieved a favorable perception by study subjects.  Conclusions: HO has a well-established safety profile and has been shown to improve both skin hydration and the overall wound healing process after dermatologic surgical procedures. J Drugs Dermatol. 2024;23(5):360-365. doi:10.36849/JDD.8224.

Evaluation of a Moisturizing Cream with 20% Urea for Keratosis Pilaris.

BACKGROUND: Keratosis pilaris (KP) is a benign dermatosis consisting of folliculocentric keratotic papules or pustules with surrounding erythema, often on proximal extensor surfaces of extremities. Management strategies for KP largely center on moisturization and exfoliation. Urea, a well-established ingredient in topical skincare, is a component of the natural moisturizing factors with concentration-dependent humectant, emollient, and exfoliative properties.  Given the overlap of urea’s properties and management goals of KP, a 4-week, open-label, noncomparative clinical study was conducted to evaluate a moisturizing cream formulated with 20% urea for use in KP.  Thirty participants aged 18 to 65 years with KP completed this study. After a 5-day washout period, study participants applied a 20% urea cream once daily to areas of KP for 4 weeks. At baseline, 1-week, and 4-week visits, clinical grading of skin texture, adverse event monitoring, and participant satisfaction questionnaires were conducted. After 1 week and 4 weeks of product use, the percent change in skin smoothness/texture from baseline was significant (P≤0.001). Furthermore, after 4 weeks of use, the majority of participants indicated satisfaction with the feel of their skin, as well as improved confidence and decreased embarrassment related to their skin. No significant adverse events were reported. Overall, the results of this study support that 20% urea cream is generally well tolerated and suitable for use in treating KP. J Drugs Dermatol. 2024;23(1):1274-1277.     doi:10.36849/JDD.7806.

Individual Article: Efficacy of Over-The-Counter Cream in Reducing Eczema Signs.

BACKGROUND: Eczema (also called atopic dermatitis) is a chronic, relapsing skin disease characterized by erythema, scaling, and pruritus. METHODS: Study 1. A double-blind, uncontrolled study in patients with mild-moderate eczema, ≥2 flares in prior 2 months, and baseline Scoring Atopic Dermatitis (SCORAD) score ≤15. Participants applied Eczema Flare-Up Relief Cream (EFRC) (N=65) BID for 56 days. Efficacy was assessed by SCORAD, patient-oriented SCORAD, skin sensitivity, Dermatology Life Quality Index (DLQI), and digital photography. Standard safety assessments were performed. STUDY 2: A 21-day open study of EFRC (N=50) to evaluate tolerability as well as its effect on eczema.  Results: Study 1. EFRC significantly reduced overall SCORAD scores from baseline to day 56 (11.6 to 4.9, or a 57% reduction). The patient-oriented SCORAD was reduced from 18.6 to 6.8 from baseline to day 56. At day 56, itch and pain improved in 70.4% of children and 62% of adults. DLQI scores were decreased by 75% in adults and 61% in children by day 56. Global skin sensitivity, assessed by the Sensiscale 10-item questionnaire, was 13.1 at baseline and 3.6 at day 56, an improvement of 72%. STUDY 2: EFRC improved eczema-prone skin after 7 and 21 days.  Conclusions: Study 1 showed that EFRC had good efficacy with significant reductions in overall SCORAD scores and subscores for the extent and intensity of eczema and subjective symptoms. Skin sensitivity also improved along with quality of life. Studies 2-3 also had significantly positive results and good tolerability. J Drugs Dermatol. 2023;22:10(Suppl 2):s5-9.

Individual Article: A Novel 3-Step Over-the-Counter Eczema Regimen Improves Eczema Severity, Itch, and Life Quality: Randomized Study.

BACKGROUND: Eczema, or atopic dermatitis (AD), is a chronic relapsing skin disease associated with unpredictable flares of erythema, rash, and pruritus. AD arises from a combination of immune system dysregulation and abnormal skin barrier function. Skin barrier support with proper skincare regimens have a central role in management. METHODS: This was a multi-center, 12-week in-use study of a skincare regimen in children and adults with mild-to-moderate eczema (6-16) on the Patient-Oriented Eczema Measure (POEM), and ≥2 flares within 3 months prior to screening. The regimen included Itch Relief Gel, Eczema Soothing Lotion, and Flare Relief Cream. Efficacy assessments included POEM, ItchyQuant, Eczema Area and Severity Index (EASI), Quality of Life and digital photography, along with gathering of adverse events and cutaneous tolerability. RESULTS: 34 subjects completed the study. In 12 weeks, mean POEM scores improved from 9.7 to 5.3, and EASI scores improved by 17.9% (P<0.05 vs baseline). Additionally, mean ItchyQuant scores showed that pruritus was significantly improved from 5.4 at baseline to 2.7 at week 12 (P<0.05). The number of flares decreased from 4.2 to 3.2 after 12 weeks of regimen application (P<0.05 vs 12 weeks before baseline). Quality-of-life measures also showed improvement in both children and adults from baseline (P<0.05). There were no related adverse events, the regimen was well tolerated, and participants had positive perceptions of the regimen. CONCLUSIONS: 12-week use of this OTC skincare regimen resulted in significant improvements in EASI, POEM, and ItchyQuant scores, a reduced number of flares, and improved quality of life. J Drugs Dermatol. 2023;22:10(Suppl 2):s21-26.

Individual Article: Evaluation of Efficacy and Tolerability of Two Over-the-Counter Eczema Itch Relief Products.

BACKGROUND: Study to compare efficacy, tolerability, and patient perception between an over-the-counter itch relief gel (IRG) and itch relief moisturizing cream (IRMC) after a single application.  Methods: Single-center, randomized, blinded, split-body study comparing IRG vs IRMC in adults with eczema-prone skin and mild-to-moderate itch. Assessments included itch relief duration upon application, itch severity (0=none to 9=severe at baseline [BL], 8, 12, and 24 hours), tolerability (0=none to 3=severe), and self-assessment questionnaire about product attributes and preference.  Results: Thirty-three females and males with a mean age of 49.7 completed the study. Average time to itch relief was 28.5 seconds for IRG vs 41.8 for IRMC (P<0.05), with first onset at 5 seconds. In the IRG group, itch severity was reduced from 4.4 at BL to 1.4 at 8 hours; in comparison, itch was reduced from 4.4 at BL to 2.6 at 8 hours in the IRMC group (P<0.05). Both products significantly relieved itch vs baseline at all time points. IRG had better tolerability, with burning/stinging going from 1.5 at BL to 0.8 at 24 hours vs 1.5 at BL to 1.2 at 24 hours for IRMC (P<0.05). There was a trend in favor of IRG vs IRMC on the patient satisfaction self-assessment questionnaire. CONCLUSIONS: IRG provided rapid itch relief and significantly outperformed IRMC. Both products significantly improved itch severity for up to 24 hours after application, with IRG outperforming IRMC at 8 hours. Additionally, IRG moderated stinging/burning sensations better than IRMC. Further, IRG was preferred by participants over IRMC.J Drugs Dermatol. 2023;22:10(Suppl 2):s10-15.  .

Individual Article: Over-the-Counter Moisturizers Significantly Improve Skin Hydration in Adults With Eczema/Atopy-Prone Skin.

BACKGROUND: Many adults suffer from dry, itchy skin, particularly those with eczema-prone skin. This study evaluated the effects of two over-the-counter (OTC) moisturizing products on skin hydration, transepidermal water loss (TEWL), ceramide levels, and patient experience. METHODS: Single-center, randomized, double-blind, split-body study evaluating the effectiveness of an Eczema Soothing Moisturizer (ESM) versus an Itch Relief Moisturizing Lotion (IRML) applied twice daily for 4 weeks in healthy adults with self-perceived persistent mild-to-moderate eczema-prone skin. Assessments included corneometer for skin hydration, evaporimeter for TEWL, tape stripping to measure ceramide NS and AS levels on the skin of the arm and leg, and a self-assessed participant-reported outcome questionnaire. RESULTS: A total of 30 adults completed the study. Both products significantly increased hydration, but the effect of ESM was greater than IRML (P=0.001), and both significantly decreased TEWL. At week 4, there were increases in NS and AS ceramides at both the legs and arms for both products (P<0.05 vs BL). Individually, ceramide content was significantly improved for ESM in the leg and for IRML in the arm at week 4 (P<0.05 vs BL). Participant photos show ESM was beneficial across a range of skin phototypes. Both products resulted in favorable perceptions from study participants. CONCLUSIONS: These moisturizers improved skin hydration, skin barrier, ceramide levels in the skin, and were well-perceived by the participants. This suggests that both products are beneficial for patients with eczema and eczema-prone skin. However, the hydrating effect of ESM was significantly greater than IRML. J Drugs Dermatol. 2023;22:10(Suppl 2):s16-20.