A double-blind, placebo-controlled study of a natural anti-inflammatory for treatment of rosacea

Jean Tang, M.D., Ph.D.¹, Ellen Lazarus, M.S.¹, June Kim, M.D.¹, Valerie Ojha, BScN, RN¹, Dale Kern, M.S.², Bryan Fuller, Ph.D.³, David Fiorentino, M.D., Ph.D.¹, Wingfield Rehmus, M.D., MPH¹

¹Stanford University School of Medicine, ²Nu Skin Enterprises, Inc, ³University of Oklahoma Health Sciences Center

Methods and Materials

Forty volunteers with rosacea were enrolled in this 12 week study. The study consisted of a screening visit, baseline visit (day 1), and assessments at day 1, week 4, week 8, and week 12. Both male and female patients, ages 18 to 70, with a confirmed diagnosis of rosacea Stage I or II by Plewig and Kligman classification of rosacea, were enrolled in the study. Informed consent was signed and IRB approval was attained from the Stanford Human Subjects Committee. 

Each subject was randomized and received either study cream or placebo (vehicle) cream. Investigators and personnel were blinded as to subject treatment assignments. Subjects applied the study cream to their face twice daily for 12 weeks. All patients were given a moisturizer with SPF 15 which could be applied 30 minutes after application of the study cream. No other skin care products or emolliants were allowed for the duration of the study. Subjects who completed at least the 8 week visit were included in the analysis with the data their final vist as the end of study data. 

At each scheduled clinic visit, patients filled out a standard questionairre for self-assessment of their erythema, pimples, dryness, and improvement. Subject assessments were on a scale from 0-100 as a percentage of maximum involvement. At each follow-up vist, subjects were asked to rate the change in their redness as improved, no change, or worse than baseline.

Rosacea severity was graded by physicians and subjects on a 5-point scale for global assessment of papules, erythema and telangiectasias.  Photographs were taken of each subject's face and were rated by blinded physicians for changes in erythema. 

Statistical analysis was preformed using the non-parametric Wilcoxon and Mann-Whitney tests given the small sample size.

Results

Figure 1. Subject at baseline                       Figure 2. Subject improvement

                                                            with study cream at 12 weeks     

At baseline, subjects in the study cream group had a higher median physician global assessment (PGA)of rosacea score of 3.0 versus a score of 2.0 in the placebo group. After treatment with the study cream for 12 weeks, the physician global assessment score decreased from 3.0 to 2.0 while the score for the placebo group increased from 2.0 to 3.0 after 12 weeks. Based on PGA, the study cream had a positive effect on rosacea, however this effect was not statistically significant in this small, pilot-study (p=0.12).