Authors 

1. Felbel, S.Seyda 

Sponsor 

New Flag GmbH, Munich, Germany 

Study Objectives: 

To investigate the effectiveness and tolerance of Natucain Eyelash solution treatment, active 7%  MKMS24, in the treatment of an eyelash enhancement using non-invasive technologies. 

Study Design 

This was a randomized, blinded, intra-individual comparative study. A total of 29 subjects participated  in the cosmetic trial that was conducted at New Flag GmbH, Munich. The study started in April and  ended in July 2021 with a duration of 12 weeks.  

Background 

The beauty industry has grown exponentially in the past decade, and so have the products available to  consumers. Eyelash enhancer is a beauty product that helps to make the eyelashes longer, fuller and  denser. The active ingredients can be found in lotions, creams, ointments and serums. 

In this cosmetic trial, the investigators aim to confirm effectiveness and tolerance of Natucain Eyelash  solution treatment, active 7% MKMS24, in the treatment of an eyelash enhancement using non invasive technologies. Natucain contains MKMS24, a unique patented (Patent No. EP3355992) anti hair loss active and a hair enhancement that is based on Lentil, Thyme and Bamboo and 100% natural  origin. 

MKMS24 strongly stimulates the dermal papilla for the production of fibroblast growth factor 7 (FGF7)  and the Noggin protein by using newest biotechnologies which extends the anagen and shortens the  telogen phase, whilst ensuring there are sufficient nutrients to allow the hair follicle to regenerate.  Noggin has an indirect function, inhibits the activity of the bone morphogenetic protein 4 (BMP4), with  a suppressive role in the transition from the Telogen phase to the Anagen. FGF7 directly stimulates the dermal papilla to start a new hair cycle. 

Patients and Methods 

The subjects were 29 voluntary patients with weak eyelashes at the company New Flag in Munich. In  the last 90 days, the volunteers did not have previous treatments to confirm the efficacy of the  treatment based on Natucain Eyelash Solution, active 7% MKMS24. Subjects applied the product twice  a day, morning and evening, according to the manufacturer’s instructions for a period of 12 weeks.  

In addition, the study assessed the number of hair follicles at different stages of the eyelash growth  cycle using non-invasive technologies and evaluated the properties of Natucain Eyelash Solutions, with 

the questionnaire being voluntary. The parameters to be studied were evaluated through  examinations, instrumental methods and a questionnaire applied by professionals. The aim of the  questionnaire was, on the one hand, the subjective assessment of the product respectively cosmetic  acceptance of the formulation and, on the other hand, the subjective evaluation of the product efficacy  (increase in eyelash length). During the study period, adverse reactions such as burning, itching, and  peeling, as well as possible contraindication to the product were evaluated. Also, no additional hair  growth hormones or creams with silicone were used during this time frame. 

The selected patients of the study had to fulfil the following characteristics: 

• Volunteers diagnosed with weak eyelashes, 
• Age between 20 and 65 years, 
• No change in hormone therapy during the last 90 days or during the study, • No topical or systemic treatments at the beginning of the study and/or 90 days before, • No history of intolerance to topical products, and 
• Signing of informed consent. 

The study excluded patients with at least one of the following traits: 

• Pregnancy or lactation, 
• Current treatment for eyelash and eyebrow in the last 6 months 
• Diagnosis of Sars Cov-2 in the past 90 days 
• History of allergic reactions to the product which is used 
• Medication that may alter the parameters to be evaluated 

The patients were evaluated on week 0, week 6, and week 12.  

The products were delivered with the manufacturer’s instructions. It was instructed to issue a warning  if any complaints arose and not to use any products that interact with the study (other treatments for  eyelash enhancement etc.). Eyelash growths were documented using photographs taken in week 0, 6  and 12. 

Results 

The products were delivered with the manufacturer’s instructions. It was instructed to issue a warning  if any complaints arose and not to use any products that interact with the study (other treatments for  eyelash enhancement etc.). 29 volunteers (female only; age between 23 and 38 years; 25 Caucasian, 3  Caribbean, 1 African) 

The subjects were 29 voluntary subjects with weak eyelashes at New Flag GmbH, Munich. In the last  90 days, the volunteers did not have previous treatments to confirm the efficacy of the treatment  based on Natucain Eyelash Solutions, active 7% MKMS24. Subjects applied the product twice a day,  morning, and evening, according to the manufacturer’s instructions for a period of 12 weeks.  

In addition, the study assessed the number of eyelash follicles at different stages of the hair growth  cycle using non-invasive technologies and evaluated the properties of Natucain Eyelash Solutions, with  the questionnaire being voluntary. The parameters to be studied were evaluated through  examinations, instrumental methods and a questionnaire applied by professionals. The aim of the  questionnaire was, on the one hand, the subjective assessment of the product respectively cosmetic 

acceptance of the formulation and, on the other hand, the subjective evaluation of the product efficacy  (The primary end point was eyelash prominence assessed by the investigator global eyelash  assessment scale.). During the study period, adverse reactions such as burning, itching, and peeling, as  well as possible contraindication to the product were evaluated. Also, no additional hair growth  hormones or skin care products with silicone were used during this time frame. 

Statistical Analysis 

Eyelash growths were documented using photographs taken in week 0, 6 and 12.  The primary end point was eyelash prominence assessed by the investigator global eyelash assessment  scale. 

Secondary efficacy measures included eyelash length measured by digital image analysis and  volunteers-reported outcomes. Safety data included adverse event monitoring. The parameters to be  studied will be evaluated through examinations, instrumental methods and a questionnaire. Hair length measurement eyelashes: In week 0, 6 and 12 the eyelash length is analysed, the lash line  is divided into three sections (left, center, right) and the length of 5 eyelashes per area is quantified  and the mean values calculated.  

Mean values calculation 

Week 0 100% 

Week 6 116% 

Week 12 129% 

Best measured result (Week 6) 

Week 0 100% 

Week 6 133% 

Week 12 136% 

Best measured result (Week12) 

Week 0 100% 

Week 6 116% 

Week 12 152% 

In summary, the study confirms the previous observations that hair density, length, pattern of growth,  and hair growth cycle vary according to their anatomical location within the eyelash. The volunteers noticed improvement in the appearance, length and volume-density within 3-4 weeks.  Two volunteers applied the product only on the upper lash area. 

Three volunteers didn’t notice any improvement of the eyelashes. 

All volunteers (100%) found the application easy. 

The cosmetics aspect of the product was accepted by all volunteers. 

The majority (90%) of volunteers would continue to use the product. 

The majority (79%) of volunteers would recommend its use. 

None of the results presented above were associated with treatment response. Also, the response to  the treatment was independent of the ethnic background and age of the subject. There were no  adverse effects associated with the use of the product.

Will you continue using the serum after  the study? (N=29) 

3; 10% 

26; 90% 

yes no 

Will you recommend the serum to a  friend? (N=29) 

6; 21% 

23; 79% 

yes no

The photos from week 0, week 6 compared to week 12 are shown below: 

Conclusions 

In this cosmetical trial, the investigators confirm the significant efficacy and tolerance of Natucain  Eyelash Solution. 

Cosmetic Study MKMS24 on eyebrows