Anti-Wrinkle Efficacy Test
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Validation Testing
Clinical Investigation Final Report FR01A/P140D20
Clinical Investigation Site: INOVAPOTEK, Pharmaceutical Research and Development Lda .
Study beginning date: July 9, 2020
Study conclusion /suspension date: September 3, 2020
Principal Investigator: Bárbara Tavares
To be able to determine the potency of Dr Kinsella CBD Facial Serum, a study needed to be conducted that could prove the efficacy of the anti-wrinkle complex in this facial serum. A blinded randomized clinical study was planned for the evaluation of the Dr Kinsella CBD Facial Serum in terms of its anti-wrinkle efficacy. With this clinical study, we aimed to assess four crucial goals.
- The first goal was to evaluate the efficacy of the cosmetic facial serum on the reduction of the wrinkles’ depth in ‘in vivo’ conditions over a period of 28 days.
- The second goal was to evaluate the effect of the cosmetic serum on the skin tone evenness in ‘in vivo’ conditions over a period of 28 days.
- The third goal was to assess the tolerance of the cosmetic facial serum over a period of 28 days. The facial serum was applied twice daily and clinical signs and symptoms were used to determine scoring scales.
- The fourth goal was to evaluate the acceptability, efficacy, tolerance and purchase intention of the investigational product by the subjects after 28 days of usage.
Twenty female volunteers (18 years old and above) participated in the study. Each of these female volunteers had visible wrinkles on the crow’s feet area and uneven skin tone. Over the course of 28 days, a mean amount of 18.52 g ± 4.12 g facial serum was applied. The mean amount applied per skin area on each single application was 0.673 mg/cm2 ± 0.235 mg/cm2. The facial serum under investigation was applied by the volunteers themselves by spreading it homogeneously over the cleansed skin of the face, twice a day, in the mornings and in the evenings. Instrumental measurements were made with equipment manufactured by Primos Premium (Canfield Scientific, Inc., United States). Skin tone evenness assessment was carried out using the Typology Angle (ITA) standard deviation. In this method, the measurements were made using the instrument Colorimeter® CL400 (Courage+Khazaka electronic GmbH, Germany). Each of these instruments were used to measure different parameters at each level of the study. The results noted after 28 days of facial serum mapplication and clinical checks were more than stellar.
Results of the Efficacy Tests Wrinkle reduction Efficacy
Table 1. Wrinkles’ depth results obtained before (t0) and after 28 days (t28) of consecutive product’s use – Facial Serum – Dr Kinsella.
After a course of 28 days of regular and consistent application of the facial serum, volunteers showed immense improvements in their wrinkle appearance. Thirteen volunteers showed depth decrease whereas the maximum depth decrease was noted at 33.79%. A decrease in the mean value of wrinkle depth was also observed. Prior to the study the mean value of wrinkle depth was noted to be 96.20. After the course of 28 days, the mean value of wrinkle depth was noted to be 90.05. This clear drop in the mean value shows that the wrinkles were targeted primarily by the facial serum and the properties of it helped reduce the depth of wrinkles in the volunteer’s skin.
Figure 1. Wrinkles’ depth mean values obtained before (t0) and after 28 days (t28) of consecutive products’ use – Facial Serum – Dr Kinsella.
Qualitative Assessments
3D pictures were obtained to gain visible proof of the results. The PRIMOS 3D pictures of eye contour wrinkles obtained before and after the study show a visible improvement
in the volunteer’s wrinkles’ appearance. The skin also appeared less rough and taut giving it a more youthful and elastic feel. This reduction in appearance is a clear positive sign of the efficacy of the facial serum.
