A cream vehicle containing N-butanoyl-l-glutathione (GSH-C4), beta-glycyrrhetinic, and azelaic acid was effective for reducing the number of facial inflammatory lesions and improving signs of mild to moderate rosacea when applied topically once a day, according to study findings published in the Journal of Cosmetic Dermatology.
In this small pilot study, researchers examined the efficacy and safety of the daily topical cream in 30 patients (mean age, 38 years) with mild to moderate facial papulopustular rosacea (mean baseline Investigator Global Assessment [IGA] score, 2.6). The study was conducted across 2 dermatology clinics in Italy.
The cream – comprising 0.1% C4-GSH, 0.5% beta-glycyrrhetinic, and 10% azelaic acid – was applied to affected areas once a day for 8 weeks. Investigators examined changes in the IGA 7-point score and the clinical and instrumental erythema severity score (ESS) at baseline to 4 weeks (clinical only) and 8 weeks (clinical and instrumental). Lesion counts and skin hemoglobin concentrations were also evaluated at these assessment periods. In addition, the researchers examined tolerability of the cream at weeks 4 and 8.
A total of 26 patients completed the required study phases and were included in the final analysis. Premature discontinuation of the trial was due to low skin tolerability in 3 patients and loss to follow up in 1 patient.
The IGA score decreased to 2.3 at week 4. At week 8, the IGA score significantly decreased to 1.2 (mean difference from baseline, 1.3; 95% CI, 0.9-1.7; P =.0001). The mean inflammatory lesion count reduced from 5.1 at baseline to 2.8 at week 4 and 1.9 at week 8, corresponding to a 63% reduction over the treatment period (P =.0001).
In addition, there was a 56% reduction in the ESS by week 8. The clinical ESS at baseline was 2.6 and reduced to 1.2 after week 8 (absolute difference, 1.4; 95% CI, 0.89-1.9; P =.0001). The investigators took ANTERA 3D photographs, which confirmed a positive evolution and a clinically and significant reduction of -24% in hemoglobin content from 1.88 at baseline to 1.44 at 8 weeks.
Limitations of this trial included its open design, lack of a placebo or control group, as well as the small sample size.
The researchers added that their “present study should be considered a pilot trial and future clinical evaluations in a larger rosacea population are warranted.”
Dall’Oglio F, Puviani M, Milani M, Micali G. Efficacy and tolerability of a cream containing modified glutathione (GSH-C4), beta-Glycyrrhetic and azelaic acids in mild-to-moderate rosacea: A pilot, assessor-blinded, VISIA and ANTERA 3-D analysis, two-center study (The “Rosazel” Trial). Published online September 3, 2020. J Cosmet Dermatol. doi:10.1111/jocd.13707