Kopexil aqua- 100 % water soluble hair growth stimulant

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KUMAR ORGANICSWELCOMES

FORPRESENTATION

ON

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Presented ByDr Ramkrishna GuptaGlobal Technical Head

Kopexil Aqua-A clinically proven 100 % water soluble Hair growth stimulant

Clinical study No.: ICB1101KOP02IP02P2


Why Hair is Important

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Kareena Kapoor-Top Bollywood actressAlthough Hair is dead tissue, but play a very important role to enhance the beauty


Hair Science • Hair is made of a structural protein called keratin.

• Two major parts: A) Hair Shaft B) Hair follicle or hair bulb.

• At the base of the follicle is the dermal papilla, feed by the bloodstream which carries nourishment to produce new hairs.

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• Any change in Hair growth cycle leads to hair loss, is a common problem affecting both men and women.

• Hair loss is a multi-factor disorder, happened due to below given reasons.

• Shrinkage of hair follicles.

• Gradual increase in telogen phase

• Reduction in A:T ratioResults in

hair loss and visible baldness

Hair Loss

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Market Potential of Hair Care products

•Global Hair Care Products Industry Revenue is Forecast to Reach an Estimated $82.2 Billion in 2018 .

• The global hair care products industry mainly comprises the manufacturers of all hair care products such as shampoos, conditioners, hair oils, hair colorants, hair treatment products, and hair styling products.

• Europe dominated this industry with the highest market share of approximately 43%, followed by Asia Pacific.

• Asia Pacific has emerged as the fastest-growing region in the industry.


FDA approved hair growth stimulants

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• Minoxidil and Finasteride are only FDA approved molecules for Hair growth, comes under schedule H and cannot be used for cosmetic applications.

• Minoxidil is treated as a gold standard but it is insoluble in water and containing high concentrations of alcohol which makes scalp dry and resulting in dandruff.

• Minoxidil also affects on blood pressure, so not ideal for BP patients.

• Kumar organic R&D team developed the innovative hair growth molecule which is 100 % soluble in water and having strong anti-oxidant property.


Do you want to be free from dandruff, itchy scalp, irritation due to alcohol based hair growth stimulant products??? Then try Kopexil Aqua

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Kopexil Aqua


Solutions Hair loss

8

4

Hair Loss prevention Men & Women

AQ

UA

PR

OD

UC

TS

PATENT PENDING “WATER SOLUBLE COMPOSITIONS FOR REATING HAIR LOSS & PROMOTING HAIR GROWTH”


Efficacy Studies

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PATENT PENDING “WATER SOLUBLE COMPOSITIONS FOR REATING HAIR LOSS & PROMOTING HAIR GROWTH”

• In-Vitro Assay (DHT release assay)• SHH gene expression (m-RNA expression)• Clinical study


DHT Release assay

• In-Vitro study was conducted in DU-145 (human prostate cancer) cells because having DHT-R

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Kopexil Aqua is potent molecule to reverse the effect of Testosterone on DHT release


Effect of Kopexil Aqua on SHH gene activation

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Up-regulation of 12.6% increase of SHH gene expression again proof that Kopexil aqua is a potent hair growth molecule.

SHH mRNA level% Improvement after

month 4

FD/WBF/KX-38 12.6%

• Sonic Hedgehog gene (SHH) is activated through WNT activation and leads to hair growth• SHH gene expression was measured through RT-PCR


Clinical Study

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Clinical Efficacy evaluation of Kopexil Aqua- A POP study

•A- Minoxidil 5 %•B. Kopexil Aqua 3 % (active content 1.5 %)

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Objective of the study:To evaluate the safety and efficacy of Kopexil Aqua hair growth stimulants through open label, randomized study for the treatment of mild to moderate Androgenic Alopecia in Male human volunteers

Test Hair growth stimulants:


Study design• Allocation: Randomized• Clinical Parameters: Efficacy Study/Safety• Duration of study: 5 months• Gender: Male• Route of application: Topical• Doses: 1 ml/ application (twice in a day)• No. of volunteers/ group: 12

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Primary Endpoints:• Hair density• Anagen/ telogen ratio (A/T ratio)• Hair diameter• Hair growth rate• Global photography assessment (Grade change)• m-RNA expression (SHH gene)Secondary endpoints:• Dermal tolerability• Consumer perception assessment

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Clinical Parameters

All the continuous variables were analyzed by using the Analysis Of Variance (ANOVA) test using SAS 9.2. Then the pair wise comparison of the treatment groups were done by using the post hoc methods i.e. Bonferroni’s or Fisher’s LSD.


Effect of Kopexil Aqua on Hair Density

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*indicates that p value is <0.05 when compared from baseline

% improvement at month 2, month 4 and month 5

Baseline Month-502468

101214

Effect of Kopexil Aqua on Hair Density

Mea

n Sc

ore

69 %

Kopexil Aqua increases the hair density by 69 % at month 5

Baseline

Fifth Month


Anagen telogen ratio (A/T ratio)

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*indicates that p value is <0.05 when compared from baseline

% improvement at month 2, month 4 and month 5Baseline Month-5

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Effect of Kopexil Aqua on Anagen/Telogen Ratio

Mea

n Sc

ore

29 %

Kopexil Aqua activates the Anagen phase of hair cycle and increases the A/T ratio by 29 % at 5th month

Telogen Anagen


HAIR DIAMETER

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Baseline Month-563

64

65

66

67

68

69

70

71

72

66.25

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Effect of Kopexil Aqua Hair DiameterH

air D

iam

eter

in u

M

8.6 %

Kopexil Aqua increases the hair diameter by 9 % at month 5, hence helps to increase the hair volume


Consumer Perceptions for Kopexil Aqua’s efficacy

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Question Responses Month 1 Month 2 Month 5Bald spot getting smaller

Agree 0% 22% 50%NA/DA 87.5% 67% 50%Disagree 12.5% 11% 0%

Appearance of hair Better 25% 56% 50%No change 37.5% 33% 50%Best 37.5% 11% 0%

Growth of hair Increased 50% 89% 50%Decreased 0% 0% 0%No change 50% 11% 50%

Effect of treatment Effective 62.5% 89% 100%Very effective 0% 0% 0%Not effective 37.5% 11% 0%

Satisfaction with appearance on area

Front 75% 45% 50%Top 25% 33% 0%Overall 0% 22% 50%

More than 50 % volunteers observed the significant improvement for all the parameters


Product’s Name

Hair density

(%)

Hairdiameter

Hair growth rate

Anagen/Telogen ratio

SHH m-RNA expression (%)

Grade Change

Safety

Minoxidil 5% 53.8 56±0 66% 50% 6.3 100 No adverse effects observed

(KOPEXIL AQUA 3 %)

69 72 100 45.9 12.6 100 No adverse effects observed

Over all Efficacy

Kopexil Aqua> Minoxidil

Efficacy Comparison Chart of Minoxidil Vs Kopexil Aqua(Baselines Vs 5th months)

The Kopexil Aqua is more effective than Minoxidil for the treatment of mild to moderate Androgenic Alopecia in Male Patients


Major benefits/Claims of Kopexil Aqua

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Kopexil Aqua

100 % Water soluble, No dry scalp, dandruff,

itchy-ness

Activates the active phase of hair

Accelerates hair growth

Potent 5α reductase inhibitorIncreases Hair

density

Strong anti-oxidant

PATENT PENDING “WATER SOLUBLE COMPOSITIONS FOR REATING HAIR LOSS & PROMOTING HAIR GROWTH” Active registered in Pre REACH registration


Product Launched

1st product launched by Green laboratory Europe


New upcoming Products Pullulan- A multifunctional bioingredient,1st Indian manufacturerL3 (Lauryl Lactyl lactate)- A secondary mild surfactant EHG (Ethyl hexyl glycerine)- Preservative and skin conditioners

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Stall No. #315


Thank You

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