Study Objectives

Anti-Hair loss effect of MKMS24 shown with a phototrichtogram analysis.
The anagen phase is the active growth phase of the hair follicles. The hair root cell is dividing rapidly. The telogen phase is the resting phase of the hair follicle.
At the end of the telogen phase the hair is shedding and the hair follicle re-enters the anagen phase. The hair density, the proportion of the hair in the anagen and telogen phase and the growth coefficient (A/T) was determined.

Sponsor

GPL German Pharma Laboratories GmbH

Study Design

This was a randomized, double-blinded, intra-individual comparative cosmetic study. A total of 17 subjects participated in the study that was conducted at German Pharma Laboratories. The study started in September 2016 and ended in January 2017 with a duration of 20 weeks.

Background

Hair loss can occur at any age, although it is more common in people aged 15 to 29. Approximately 30 to 40% of women experience hair loss. Men are considerably more affected by hair loss. Statistically 70% of men experience this issue.

In this trial, the investigators aim to confirm the efficacy and tolerance of Hair Activator Solutions, active 7% MKMS24, in the treatment of non-scarring diffuse alopecia areas using non-invasive technologies in treating hair loss. Hair Activator Solution contains active 7% MMS24, a unique anti-hair loss active that is based on Lentil, Thyme and Bamboo. MKMS24 strongly stimulates the dermal papilla to produce fibroblast growth factor 7 (FGF7) and the Noggin protein. Noggin has an indirect function, inhibiting the activity of 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. MKMS24 also acts by inhibiting 5 alpha reductases.

Patients and Methods

The subjects were 17 voluntary patients with diffuse hair loss. Female with a telogen phase ≥ 20%, Male with a telogen phase ≥ 20% and with a hair density ≥ 150 hair/sqcm. In the last 90 days, the volunteers did not have previous treatments to confirm the efficacy of the treatment based on Hair Activator Solutions, active 7% MKMS24. Patients applied the product twice a day, morning, and evening, according to the manufacturer’s instructions for a period of 20 weeks.

In addition, the study assessed the number of hair follicles at different stages of the hair growth cycle using non-invasive technologies and evaluated the properties of Hair Activator Solutions, with the questionnaire being voluntary. The parameters to be studied were evaluated through clinical examinations, instrumental methods and a questionnaire applied by professionals. 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 silicone shampoo were used during this time frame.
The selected patients of the study had to fulfil the following characteristics:

• Volunteers diagnosed with non-scarred diffuse alopecia,
•  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 alopecia or during the last 6 months,
•  Diagnosis of cicatricial alopecia,
•  Anagen effluvium,
•  History of allergic reactions to the product, which is used, or

•  Systemic, cutaneous pathology or any medication that may alter the parameters to be 

  evaluated.

 

The patients were evaluated on Day 0, Day 2, Week 20 Day 0 and Week 20 Day 2. First, the type of alopecia was diagnosed. This was achieved by looking at the clinical history, carrying out a physical examination and, if necessary, conducting laboratory tests (hematologic, ferremia, thyroid profile). Identification of the surface area (2sqcm) on the back of the scalp.

Hair was shaved on the defined zone and image acquisition of the studies zone using photomicroscope Nikon D90 Canfield Epiflash.
Week 0 Day2
Image acquisition of the studied zone defined on the scalp in Week 0 Day 0.

Determination of the hair formula:

•  Hair density
•  Density of the hair in the anagen phase
•  Density of the hair in the telogen phase
• Application of 7% MKMS24 twice a day (morning and evening)
• The products were delivered with the manufacturer’s instructions and a standard shampoo was provided. It was instructed to issue a warning if any complaints arose and not to use any products that interact with the study (anti-hair loss shampoo, other treatments for hair loss etc.).
• Week 20 Day 0
• Location of the zone defined in week 0. Hair was shaved and image acquisition of the studied zone. Week 20 Day 2
• Location of the zone defined in week 0.
• Determination of the hair formula:
•  Hair density
•  Density of the hair in the anagen phase

•  Density of the hair in the telogen phase

Test parameters:

•  Measurements with phototrichogram technique:

Nikon D80 camara coupled with Canfield Epiflash equipped with contact lens. Evaluated parameters:

•  Capillary density: total number of hairs on studied zone peer sqcm
•  Density of the hair in the anagen phase (A)
•  Proportion in % and density of the hair in the telogen phase (T)

•  Growth coefficient (A/T)

Results

The products were delivered with the manufacturer’s instructions and a standard shampoo was provided. It was instructed to issue a warning if any complaints arose and not to use any products that interact with the study (anti-hair loss shampoo, other treatments for hair loss etc.).
The subjects were 17 voluntary patients with diffuse non-scarring. In the last 90 days, the volunteers did not have previous treatments to confirm the clinical efficacy of the treatment based on Hair Activator Solutions, active 7% MKMS24. Patients 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 hair growth cycle using non-invasive technologies and evaluated the properties of Hair Activator Solutions. The parameters to be studied were evaluated through clinical examinations and instrumental methods. 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 silicone shampoo were used during this time frame.

In summary, 17 patients have completed the study. In total, there were 7 women (41%) and 10 men (59%), with the average age of the sample being 39,6 years.
After 20 weeks of treatment patients have a significantly higher anagen trichogram, p<0.001, and a significantly lower telogen trichogram, p<0.001.

Versus initial conditions

Versus initial conditions

Versus initial conditions

None of the results presented above were associated with treatment response. Also, the response to the treatment was independent of the sex and age of the patient. There were no adverse effects associated with the use of the product. After 20 weeks of MKMS24 twice a day a significant growth coefficient increase of 93% was observed. 93% of the volunteers presented a positive effect on MKMS24.

The clinical photo from day 0 compared to week 20 are shown below:

     

The patients who used the Hair Activator Solutions showed statistically significant improvement in the trichogram, with an increase in anagen hairs and decrease a decrease in telogen hairs. This corresponded to the patients’ perception of improvement in the appearance, volume-density, and decrease in hair loss. Also, the cosmetics aspect of the product was accepted by most patients. Most patients would continue to use the product and recommend its use.

Conclusions

In this clinical trial, the investigators confirm the significant efficacy and tolerance of Hair Activator MKMS24.