Randomized study to assess the efficacy of a facial cosmetic product with nanoencapsulated cysteamine in women presenting melasma
472
Presented by: Luana Lopes
Introduction - Melasma is a common and persistent pigmentary disease that particularly affects women during their reproductive period. It is characterized by symmetrical hyperpigmented macules or patches with irregular borders, most often distributed on the face. The chronicity of the disease and the involvement of visible areas during working age generates a great negative impact on the quality of life of affected individuals.
The present study aimed to use nano encapsulated cysteamine, a promising and more tolerable option when compared to other treatments in the treatment of melasma.
Methods - This single-blind, randomized, and comparative study of a cosmetic product with nano encapsulated cysteamine and sunscreen versus sunscreen alone was conducted to investigate the efficacy of a cosmetic product with nano encapsulated cysteamine in improving melasma hyperpigmentation and improving the quality of life of subjects with melasma through MelasQoL in adult women. The study included 43 adult women, aged 33 - 55 years, phototype III to V (Fitzpatrick), having melasma in their face and chronic non-smokers. These subjects were randomized into two groups: 24 subjects used the IP daily plus sunscreen SPF 60 for 84 days, while 19 subjects used only the sunscreen SPF 60 for 84 days. Evaluations were performed on day 0, day 56, and day 84. Melasma hyperpigmentation intensity, the area affected by melasma, skin tone uniformity, skin hydration, softness, luminosity and oiliness were assessed by a dermatologist. Moreover, any possible local intolerance and adverse event were investigated and collected by the dermatologist.
Instrumental evaluations were performed to investigate the efficacy of a cosmetic product with nano encapsulated cysteamine in the characteristics of the epidermis, dermo-epidermal junction, and dermis – through Confocal Reflecting Microscopy. In addition, Color Face and Skincam photography equipment were also used to illustrate the efficacy of the investigational product. In 28, 56, 84 days after products use, subjects answered questionnaires regarding the subjective perceived efficacy and the impact of melasma on their quality of life through MelasQoL.
Results - Clinical results showed that for the treatment group, which used the investigational product and sunscreen FPS60, after 84 studies there was a significant improvement (p <0.001) of 44.7% in the melasma hyperpigmentation intensity. The affected area by melasma also showed a significant improvement (p <0.001) of 27.5% after 84 days of treatment. Furthermore, for the treatment group, after 84 days, there was a significant (p <0.001) improvement of 41.5% in skin tone uniformity, significant improvement (p <0.001) of 60.5% in skin hydration, significant (p<0.001) improvement of 68.9% in skin smoothness, significant improvement (p<0.001) of 76.9% in skin luminosity and significant improvement (p<0.034) of 15.8% in skin oiliness. For the control group, after 84 days of study, there was a significant improvement (p 0.003) of 29.0% in the melasma hyperpigmentation intensity, a significant improvement (p 0.025) of 15.6% in skin hydration, a significant improvement (p < 0.001) of 44.3% in skin smoothness, significant improvement (p 0.003) of 31.0% in skin luminosity and significant improvement (p 0.014) of 20.7% in skin oiliness.
MelasQol results revealed a significant difference (p 0.003) in the impact of melasma on quality of life after 84 days after IP use when compared to the control group. Reflective confocal microscopy results showed pigment reduction in keratinocytes in the epidermis, around adnexal structures and at the dermal-epidermal junction.
Discussion - During the study, it was possible to observe during the comparison between two groups, a significant improvement of melasma hyperpigmentation intensity after 56 days (p 0.004) using investigational product plus sunscreen and a significant improvement of the affected area by melasma (p <0.001), uniformity of the skin tone (p 0.001), skin hydration (p <0.001), smoothness (p 0.006) and luminosity (p <0.001) after 84 days using investigational product plus sunscreen when compared to the group sunscreen only.
Conclusion The cosmetic product with nano encapsulated cysteamine improves the melasma hyperpigmentation intensity and affected area by melasma when compared to the control group, with a good tolerability profile.
The present study aimed to use nano encapsulated cysteamine, a promising and more tolerable option when compared to other treatments in the treatment of melasma.
Methods - This single-blind, randomized, and comparative study of a cosmetic product with nano encapsulated cysteamine and sunscreen versus sunscreen alone was conducted to investigate the efficacy of a cosmetic product with nano encapsulated cysteamine in improving melasma hyperpigmentation and improving the quality of life of subjects with melasma through MelasQoL in adult women. The study included 43 adult women, aged 33 - 55 years, phototype III to V (Fitzpatrick), having melasma in their face and chronic non-smokers. These subjects were randomized into two groups: 24 subjects used the IP daily plus sunscreen SPF 60 for 84 days, while 19 subjects used only the sunscreen SPF 60 for 84 days. Evaluations were performed on day 0, day 56, and day 84. Melasma hyperpigmentation intensity, the area affected by melasma, skin tone uniformity, skin hydration, softness, luminosity and oiliness were assessed by a dermatologist. Moreover, any possible local intolerance and adverse event were investigated and collected by the dermatologist.
Instrumental evaluations were performed to investigate the efficacy of a cosmetic product with nano encapsulated cysteamine in the characteristics of the epidermis, dermo-epidermal junction, and dermis – through Confocal Reflecting Microscopy. In addition, Color Face and Skincam photography equipment were also used to illustrate the efficacy of the investigational product. In 28, 56, 84 days after products use, subjects answered questionnaires regarding the subjective perceived efficacy and the impact of melasma on their quality of life through MelasQoL.
Results - Clinical results showed that for the treatment group, which used the investigational product and sunscreen FPS60, after 84 studies there was a significant improvement (p <0.001) of 44.7% in the melasma hyperpigmentation intensity. The affected area by melasma also showed a significant improvement (p <0.001) of 27.5% after 84 days of treatment. Furthermore, for the treatment group, after 84 days, there was a significant (p <0.001) improvement of 41.5% in skin tone uniformity, significant improvement (p <0.001) of 60.5% in skin hydration, significant (p<0.001) improvement of 68.9% in skin smoothness, significant improvement (p<0.001) of 76.9% in skin luminosity and significant improvement (p<0.034) of 15.8% in skin oiliness. For the control group, after 84 days of study, there was a significant improvement (p 0.003) of 29.0% in the melasma hyperpigmentation intensity, a significant improvement (p 0.025) of 15.6% in skin hydration, a significant improvement (p < 0.001) of 44.3% in skin smoothness, significant improvement (p 0.003) of 31.0% in skin luminosity and significant improvement (p 0.014) of 20.7% in skin oiliness.
MelasQol results revealed a significant difference (p 0.003) in the impact of melasma on quality of life after 84 days after IP use when compared to the control group. Reflective confocal microscopy results showed pigment reduction in keratinocytes in the epidermis, around adnexal structures and at the dermal-epidermal junction.
Discussion - During the study, it was possible to observe during the comparison between two groups, a significant improvement of melasma hyperpigmentation intensity after 56 days (p 0.004) using investigational product plus sunscreen and a significant improvement of the affected area by melasma (p <0.001), uniformity of the skin tone (p 0.001), skin hydration (p <0.001), smoothness (p 0.006) and luminosity (p <0.001) after 84 days using investigational product plus sunscreen when compared to the group sunscreen only.
Conclusion The cosmetic product with nano encapsulated cysteamine improves the melasma hyperpigmentation intensity and affected area by melasma when compared to the control group, with a good tolerability profile.