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

October 2023 | Volume 22 | Issue 10 | SF388641s5 | Copyright © October 2023


Published online September 30, 2023

Adelaide A. Hebert MDa, Mathieu Grivet-Seyve PhDb, Sarah Anjuwon MSb, Nathalie Piccardi PhDc, Nadège Lachmann PhDd, Agustin Cruz MDe, Christine Emesiani PharmD

aUTHealth McGovern Medical School, Houston, TX  
bGalderma R&D, Dallas, TX  
cGalderma R&D, Lausanne, Switzerland 
dGalderma Sensitive Skincare Faculty, Lausanne, Switzerland 
eGalderma Laboratories, L.P., Dallas, TX

RESULTS

Study 1: Efficacy Clinical Trial
A total of 65 participants were included in the intent-to-treat (ITT) population, and applied EFRC. Table 1 presents patient demographics for Study 1.

The mean SCORAD score was reduced from 11.57 at baseline to 4.89 (-57%, P<0.001) at day 56 of twice-daily EFRC use (Figure 1). The mean extent (percentage of area) of involvement was significantly reduced from baseline 7.8 to 2.8 at day 56 (-64.1%, P<0.001), and intensity decreased from 2.42 at baseline to 1.05 at day 56 (-56.8%, P<0.001). The subjective symptoms of pruritus and sleep loss on dermatologist-assessed SCORAD improved from 1.53 to 0.61 (-60.2%, P<0.001) by day 56. The majority of participants maintained a SCORAD score of 15 or below for the 8-week period. The overall PO-SCORAD scores improved from 18.6 at baseline to 6.8 at day 56 (-63%, P<0.001). Additionally, there was a statistically significant reduction in itch and sleep disturbance on PO-SCORAD at day 56. In response to the question of how itchy, sore, or painful their skin had been over the last week, 70.4% of pediatric participants and 62.2% of adults reported improvement.

Quality-of-life scores were significantly improved in both children and adults who used twice-daily EFRC by 61% and 75%, respectively (Figure 2). Figure 3 shows the improvements (P<0.001) in Sensiscale Global Scores (a measure of skin sensitivity) as well as the evolution of individual eczema-related items (P<0.001 for all at day 56). A representative case of eczema improvement in dark skin is shown in Figure 4.

Study 2: Open-label Trial
A total of 36 female and 13 male White patients participated, with a mean age of 41 ± 2 years and phototype I-III skin. All had sensitive skin, and 31 participants reported sensitive eyes. EFRC improved skin smoothness, dryness, scaling, and redness on days 7 and 21 (Table 2). Sensiscale evaluations at day 21 showed significant improvements in all individual aspects of skin sensitivity (irritation, tingling, burning, heat sensation, tautness, itching, pain, general discomfort, hot flashes, and redness) as well as an 86% improvement in mean overall score. As shown in Table 3, participants had favorable impressions of EFRC. Figure 5 shows representative clinical photos.

In Study 1, no adverse events were reported at any study sites. Tolerability evaluations showed a statistically significant decrease (improvement) for erythema and burning on days 14 and 56. Stinging was improved at week 8, and itching decreased after 8 weeks of use compared to baseline. Tolerability was good in Study 2, also.

DISCUSSION

Keeping skin hydrated and moisturized is a key preventative for skin affected by eczema and atopic dermatitis. These studies show that EFRC is effective in providing relief to patients with eczema as reflected by SCORAD, PO-SCORAD, DLQI, and Sensiscale scores. In addition, it is very well tolerated at the cutaneous level without producing any signs of eye irritation. Finally, EFRC improved skin roughness, dryness, scaling, and erythema. Separate studies have provided positive supportive results in both symptoms and skin hydration, also with good safety.

DISCLOSURES

Dr Hebert has received research grants paid to medical school from Pfizer, Arcutis, Dermavant, Abbvie, Leo, Lilly;  honoraria from Galderma, Pfizer, Arcutis, Incyte, Beiersdorf, Almirall, Amyrt, Boehringer Ingelheim, Ortho Dermatologics; and as an advisor for Ortho Dermatologics; Sanofi Regeneron, GSK.

REFERENCES

  1. Silverberg JI. Public health burden and epidemiology of atopic dermatitis. Dermatol Clin. 2017;35:283-9. 
  2. McCleary, KK. The More Than Skin Deep “Voice of the Patient” Report. 2020. Available at: https://www.morethanskindeep-eczema.org/report.html. Accessed May 1, 2023.
  3. Wang J, Zhou Y, Zhang H, et al. Pathogenesis of allergic diseases and implications for therapeutic interventions. Signal Transduct Target Ther. 2023;8:138.
  4. Tollefson MM, Bruckner AL, Section On D. Atopic dermatitis: Skin-directed management. Pediatrics. 2014;134:e1735-44.
  5. Misery L, Jean-Decoster C, Mery S, et al. A new ten-item questionnaire for assessing sensitive skin: The sensitive scale-10. Acta Derm Venereol. 2014;94:635-9.

AUTHOR CORRESPONDENCE

Christine Emesiani PharmD Christine.Emesiani@galderma.com
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