Randomized parallel control trial checking the efficacy and impact of two concentrations of retinol in the original formula on the aging skin condition: Pilot study

Abstract

Background: The aging process is defined as natural, biological, progressive, and physiologically irreversible phenomena occurring in the body.

Objective: We attempted to evaluate the efficacy and tolerability of treating signs of the aging skin using retinol 0.15% and 0.3%. Retinol was added to the original, developed liquid crystal formula.

Methods: Patients at two sites (n = 20, n = 20) presenting signs of aging applied a novel formulation of retinol at 0.15% (on the left) and 0.3% (on the right) concentrations daily to their faces for 2 months. An expert blinded evaluation of images was carried out after 8 weeks. Tolerability was assessed throughout the whole study. Positive results of the observational pilot study guaranteed a follow-up trial with the use of the higher concentration and another parallel study.

Results: In the observational pilot study, most of the participants showed an improvement in the overall skin condition. These improvements were assessed after 4 and 8 weeks. Those observed after 56 days were more remarkable than those identified 28 days, however, without any statistical significance. Application of retinol formula 0.3% and serum 0.15% gives similar results after 8 weeks of daily care. Both products improve the overall skin condition considerably, even the skin color, hydration, and radiance. In a VAS assessment, the number of wrinkles decreased and skin discoloration was reduced. Side effects such as burning, dryness, pruritus, and erythema during the 8-week study period were minimal.

Conclusions: The topical formulation of liquid crystal serum with retinol 0.15% and 0.3% improves the overall skin condition after 8 weeks. Burning, pruritus, dryness, and erythema caused by the application of retinol 0.15% and 0.3% concentrations were minimal. Nevertheless, there were no significance changes found between the left and right side of the face. These encouraging results justify a longer-term study to determine whether topically applied retinol 0.3% can provide more benefits as compared to those observed after topical application of retinol 0.15%.

Keywords: Scientific Committee on Consumer Safety; application study; pilot study; retinol; vitamin A.