Clinical trial results published in the Journal of Cosmetic Dermatology support the efficacy of a skin care cream containing the transient receptor potential vanilloid type 1 (TRPV1)-inhibitor 4-t-butylcyclohexanol for the treatment of perioral dermatitis (POD).
Investigators conducted an open, unblinded, 8-week clinical trial that included 48 patients with POD. All patients were supplied with a 50-g tube of the cream containing 4-t-butylcyclohexanol (brand name: Eucerin UltraSENSITIVE®, Beiersdorf AG) and instructed to apply the cream twice daily. Study assessments were conducted at enrollment, at 4 weeks, and at 8 weeks. The primary endpoint was improvement in POD severity index (PODSI) after 4 weeks. Secondary endpoints included PODSI domain scores, subjective POD severity scores, dermatologic life quality index scores, and assessments of 6 skin physiologic parameters. Adverse events were assessed throughout the 8-week trial duration.
Of 48 initial enrollees, 42 completed the treatment period. Mean age of enrollees was 42.4 years (range, 19 to 81 years) and the majority (87.5%) were women. The duration of POD in patients ranged from 1 week to 10 years. Baseline mean (±SD) PODSI score was 4.71 ± 1.37. Mean (±SD) PODSI score was significantly reduced at both the 4-week (2.83 ± 17.5) and 8-week (1.42 ± 1.36) timepoints (both P <.0001). All 3 PODSI elements displayed significant reduction over 8 weeks: erythema, papules, and scaling (all P <.0001). The mean (±SD) subjective disease severity index decreased from 6.74 ± 1.93 (out of 10) at baseline to 4.51 ± 2.61 (P <.0001) at 4 weeks and 2.74 ± 2.35 at 8 weeks. Mean (±SD) dermatologic life quality index score also significantly decreased from baseline to 4 weeks (10.07 ± 5.21 vs 5.10 ± 4.89; P <.0001) and continued to decrease through week 8 (2.19 ± 2.94).
Significant improvements in transepidermal water loss, stratum corneum hydration, and erythema were observed during the trial, although sebum level, skin elasticity, and firmness did not change. The cream was well tolerated by participants. One-third of patients reported increased skin tenderness and erythema in the first week of treatment, although these symptoms resolved with time.
These data demonstrate the efficacy and tolerability of topical cream containing a TRPV1 inhibitor in POD treatment. As a single-arm, unblinded trial, however, results must be extrapolated with care. Further research is necessary in a randomized clinical trial to confirm these findings. “A 4‐t‐butylcyclohexanol cream could be a clinically useful treatment option for POD, especially due to the absence of side effects and the lack of limitations in the duration of treatment,” the investigators wrote.
Disclosure: This clinical trial was supported by Beiersdorf, the company that produces Eucerin UltraSENSITIVE®. Please see the original reference for a full list of authors’ disclosures.
Srour J, Bengel J, Linden T, et al. Efficacy of a skin care cream with TRPV1 inhibitor 4‐t-butylcyclohexanol in the topical therapy of perioral dermatitis [published online October 29, 2019]. J Cosmet Dermatol. doi:10.1111/jocd.13175