and specifically combination benzoyl peroxide/retinoid topical medications in the past 3 months, any oral acne medications in the past 4 weeks, any systemic isotretinoin in the past 6 months, and any anti-androgens in the past 3 months.
At all visits, the investigator assessed the skin for objective irritation parameters including erythema, dryness, scaling/ peeling, and edema. The participants also assessed skin irritation in terms of burning, itching, tightness, and dryness. The assessments were completed on a 5-point ordinal scale: 0=none, 1=minimal, 2=mild, 3=moderate, 4=severe. Investigator efficacy was determined by IGA assessment (IGA: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe) along with inflammatory and non-inflammatory lesion counts. TEWL (Evaporimeter, Cyberderm, Broomall, PA) measurements were taken from the right cheek after washing the face with the assigned cleanser and acclimating to the study environment for 30 minutes.
Participants were randomized to receive A/BPO (Taro) once daily in the evening and a ceramide-containing foaming facial cleanser with a ceramide-containing facial lotion twice daily (ceramide treatment group: CeraVe Foaming Cleanser, CeraVe Facial Moisturizing Lotion, CeraVe LLC) or A/BPO once daily in the evening and a basic foaming face wash twice daily (control group: Sébium Foaming Gel Bioderma). Participants were dispensed their acne medication product and ancillary skincare products along with instructions and an application demonstration. They were instructed to use their self-selected sunscreen as needed. A compliance diary was provided for recording all product applications.
A Mann-Whitney two-tailed paired test was used to analyze the non-parametric ordinal data. Numerical acne lesion count data was analyzed using a Student t-test. Statistical significance was defined as P<0.05.
At all visits, the investigator assessed the skin for objective irritation parameters including erythema, dryness, scaling/ peeling, and edema. The participants also assessed skin irritation in terms of burning, itching, tightness, and dryness. The assessments were completed on a 5-point ordinal scale: 0=none, 1=minimal, 2=mild, 3=moderate, 4=severe. Investigator efficacy was determined by IGA assessment (IGA: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe) along with inflammatory and non-inflammatory lesion counts. TEWL (Evaporimeter, Cyberderm, Broomall, PA) measurements were taken from the right cheek after washing the face with the assigned cleanser and acclimating to the study environment for 30 minutes.
Participants were randomized to receive A/BPO (Taro) once daily in the evening and a ceramide-containing foaming facial cleanser with a ceramide-containing facial lotion twice daily (ceramide treatment group: CeraVe Foaming Cleanser, CeraVe Facial Moisturizing Lotion, CeraVe LLC) or A/BPO once daily in the evening and a basic foaming face wash twice daily (control group: Sébium Foaming Gel Bioderma). Participants were dispensed their acne medication product and ancillary skincare products along with instructions and an application demonstration. They were instructed to use their self-selected sunscreen as needed. A compliance diary was provided for recording all product applications.
A Mann-Whitney two-tailed paired test was used to analyze the non-parametric ordinal data. Numerical acne lesion count data was analyzed using a Student t-test. Statistical significance was defined as P<0.05.
RESULTS
The study enrolled 100 participants to complete a with a minimum of 80 participants. Ninety-one participants successfully completed the study (45 participants completed the treatment regimen and 46 participants completed the control regimen). Nine participants discontinued for personal reasons unrelated to the study products. All Fitzpatrick skin types were represented. No adverse events occurred during the conduct of the study.
The study was conducted during the COVID-19 pandemic and TEWL measurements were performed anterior to the right ear around the face mask. Figure 1 demonstrates the increase in TEWL at week 1 in both regimens after treatment initiation, however, the TEWL increase was less for the ceramide treatment group than the control group. TEWL continued to decrease over time for both groups, but there was a statistically significant superior decrease for the ceramide treatment group over the control group at weeks 4, 8, and 12. This bioinstrumental finding was confirmed at the clinical level by the dermatologist investigator ratings for dryness, erythema, and scaling (Figure 2). Beginning at week 1 and continuing through week 4, the ceramide treatment group demonstrated statistically significant less dryness (Figure 2a) as compared to the control group. Erythema resolved in the ceramide treatment group at week 8 but remained in the control group until the end of the study
The study was conducted during the COVID-19 pandemic and TEWL measurements were performed anterior to the right ear around the face mask. Figure 1 demonstrates the increase in TEWL at week 1 in both regimens after treatment initiation, however, the TEWL increase was less for the ceramide treatment group than the control group. TEWL continued to decrease over time for both groups, but there was a statistically significant superior decrease for the ceramide treatment group over the control group at weeks 4, 8, and 12. This bioinstrumental finding was confirmed at the clinical level by the dermatologist investigator ratings for dryness, erythema, and scaling (Figure 2). Beginning at week 1 and continuing through week 4, the ceramide treatment group demonstrated statistically significant less dryness (Figure 2a) as compared to the control group. Erythema resolved in the ceramide treatment group at week 8 but remained in the control group until the end of the study
