Efficacy and tolerability of a facial serum for fine lines, wrinkles, and photodamaged skin

Abstract

Background: Dermatology visits for the prevention and treatment of aging skin are rapidly increasing. The clinical sequelae including wrinkling, pigmentary changes, roughness, laxity, and telangiectasia can all result in the appearance of aging skin, impacting quality of life. A facial serum was developed with ingredients associated with an improvement in the appearance of fine lines and wrinkles and increase in stratum corneum barrier function. Patients were instructed to use a gentle wash before applying the formulation and a moisturizer afterwards.

Objective: To assess the efficacy and tolerability of a facial serum in improving the appearance of fine lines, wrinkles, and signs of photodamage.

Methods: Thirty-four female subjects (Fitzpatrick classification I-IV) with early to advanced photodamaged skin in a 12-week, single-arm, open-label clinical trial. Visits were scheduled at Baseline and Weeks 4, 8, and 12. Efficacy was assessed using visual grading of facial and periocular skin (modified 10-point scales); changes in viscoelasticity properties were assessed by cutometry. Cutaneous tolerability was evaluated both clinically and subjectively using a 4-point scale and monitoring adverse events. Digital photography documented treatment-related changes in skin appearance. Subjects completed self-assessments at Baseline and Weeks 4, 8, and 12.

Results: Significant improvements in all parameters and skin condition were seen as early as Week 4 (p≤0.05). There was an 18-percent improvement in overall appearance by Week 12 (p≤0.05). Fine lines and coarse winkles improved by 27 and 15 percent, respectively (both p≤0.05). Significant improvements were also seen in uneven pigmentation, firmness/elasticity, toned/resiliency, skin radiance, tone, and tactile roughness/smoothness (10%, 11%, 18%, 21%, 16%, and 47%, respectively; allp≤0.05). By Week 12 subjects reported a 43-percent improvement in overall facial skin appearance and 24-percent reduction in mean scores for facial lines and wrinkles (bothp≤0.05). Improvements were also reported in overall skin tone, firmness, dryness, appearance of pores, appearance of brown spots/facial discoloration, skin radiance, and texture (37%, 35%, 35%, 28%, 24%, 39%, 38%, respectively; allp≤0.05). There was a 71-percent reduction in erythema and 94-percent reduction in skin dryness by Week 12 (both p≤0.05).

Conclusion: The facial serum, in combination with the wash and moisturizer, may be effective and well-tolerated when treating photodamaged skin and may improve the appearance of fine lines and wrinkles. Significant improvements were seen with all grading parameters as early as four weeks of usage. A controlled study is warranted to further validate these findings.

Figure 1

Subject eligibility

Figure 2

Clinical efficacy: Periocular area. Mean values from Baseline to Week 12

Figure 3

Clinical efficacy: Global face. Mean values from Baseline to Week 12

Figure 4

Clinical efficacy: Subject self-assessment. Skin condition at Baseline and Week 12

Figure 5

Subject satisfaction: Self-assessment. Improvement in skin condition by Week 12