An Open Label Clinical Trial of a Peptide Treatment Serum and Supporting Regimen Designed to Improve the Appearance of Aging Facial Skin

September 2016 | Volume 15 | Issue 9 | Original Article | 1100 | Copyright © September 2016

Zoe Diana Draelos MD,a Tatiana Kononov BS MBA,b and Theresa Fox BSb

aDermatology Consulting Services, High Point, NC
bRevision Skincare, Irving, TX

Efficacy of Serum: Subject Assessment at Week 14 Lower Eyelids to Hairline

The subjects were asked to examine only the lower eyelids to the hairline at 14 weeks and assess the peptide treatment serum using the numeric scale. They agreed they had better skin texture (mean=0.97), more radiance (mean=1.10), improved fine lines (mean=1.03), improved wrinkles (mean=1.31), improved crow’s feet wrinkles (mean=1.24), improved undereye wrinkles (mean=1.28), healthier-looking skin (mean=0.93), younger, firmer skin (mean=1.52), more moisturized skin (mean=0.86), and overall improved appearance (mean=1.10) on the skin from the lower eyelids to the hairline when compared to baseline results.

Clinical Grading Efficacy Parameters: Subject Assessment at Rest

A marked improvement was noted by the subjects at week 10. There was significant improvement in facial lines (P=0.049), facial wrinkles (P=0.030), eye wrinkles (P=0.020), smoothness (P=0.023), softness (P=0.004), firmness (P=0.001), radiance (P=0.001), luminosity (P<0.001), pigmentation (P=0.028), and overall appearance (P<0.001) when compared to baseline results.

At week 14, there was statistically significant improvement in facial lines (P=0.002), facial wrinkles (P=0.013), eye lines (P=0.002), wrinkles (P=0.043), smoothness (P=0.003), softness (P=0.003), firmness (P=0.001), radiance (P<0.001), luminosity (P<0.001), and overall appearance (P<0.001) when compared to baseline results (Table 3).
Concerning tolerability attributes, the panelists noted a statistically significant increase in erythema (P=0.025) and desquamation (P=0.018) at week 2 when compared to baseline results. The subjects returned at week 6, and the desquamation was no longer statistically significant, although the increased erythema remained significant (P=0.022). The subjects continued to note that erythema remained significant (P=0.038) at week 10 when compared to baseline results but this cleared at week 14.

Safety/Tolerability

The facial peptide-based regimen was well tolerated by the panelists with no statistically significant increase in erythema, desquamation, stinging, burning, or itching noted by the expert investigator when compared to baseline results at any time point. The subjects noted a statistically significant increase in desquamation and erythema at week 2 compared to baseline results. The increase in desquamation was resolved and was no longer significant after week 2. The erythema persisted to week 10 but was resolved and was no longer statistically significant at week 14 when compared to baseline results. The increase in desquamation and erythema perceived by the subjects was not perceived by the investigator. In addition, the subjects agreed that the peptide treatment serum (mean=0.62 on a 0-4-point scale) and the other products (mean= 0.34 on a 0-4-point scale) did not cause irritation when compared to baseline results. Also, concerning the efficacy of the products other than the peptide treatment serum, the subjects agreed that they had less redness (mean=1.34 on a 0-4-point scale) at week 14 compared to baseline results. Lastly, no adverse events were observed or reported during the study period.
table 5

Compliance

No compliance issues were noted during the study either by diary or product weight.