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© Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I
KUMAR ORGANICS
WELCOMES
FOR
PRESENTATION
ON
1
Presented By
Dr Ramkrishna Gupta
Global Technical Head
Kopexil Aqua-A clinically proven
100 % water soluble Hair growth stimulant
Clinical study No.: ICB1101KOP02IP02P2
© Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I
Why Hair is Important
2
Kareena Kapoor-Top Bollywood actress
Although Hair is dead tissue, but play a very important role to enhance the beauty
© Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I
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.
3
© Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I
• 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
4
© Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I
5
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.
© Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I
FDA approved hair growth stimulants
6
• 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.
© Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I
Do you want to be free from dandruff, itchy scalp, irritation
due to alcohol based hair growth stimulant products???
Then try Kopexil Aqua
7
Kopexil Aqua
© Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I
Solutions Hair loss
8
4Hair Loss prevention Men & Women
AQUAPRODUCTS
PATENT PENDING “WATER SOLUBLE COMPOSITIONS FOR REATING HAIR LOSS & PROMOTING HAIR GROWTH”
© Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I
Efficacy Studies
9
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
© Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I
DHT Release assay
• In-Vitro study was conducted in DU-145 (human prostate cancer) cells because
having DHT-R
10
Kopexil Aqua is potent molecule to reverse the effect of Testosterone on
DHT release
© Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I
Effect of Kopexil Aqua on SHH gene activation
11
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
© Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I
Clinical Study
12
© Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I
Clinical Efficacy evaluation of Kopexil Aqua- A POP study
•A- Minoxidil 5 %
•B. Kopexil Aqua 3 % (active content 1.5 %)
13
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:
© Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I
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
14
© Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I
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
15
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.
© Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I
Effect of Kopexil Aqua on Hair Density
16
*indicates that p value is <0.05 when compared from baseline
% improvement at month 2, month 4 and month 5
0
2
4
6
8
10
12
14
Baseline Month-5
MeanScore
Effect of Kopexil Aqua on Hair Density
69 %
Kopexil Aqua increases the hair density by 69 % at month 5
Baseline
Fifth Month
© Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I
Anagen telogen ratio (A/T ratio)
17
*indicates that p value is <0.05 when compared from baseline
% improvement at month 2, month 4 and month 5
0
2
4
6
8
10
Baseline Month-5
MeanScore
Effect of Kopexil Aqua on Anagen/Telogen
Ratio
29 %
Kopexil Aqua activates the Anagen phase of hair cycle and increases the A/T ratio by 29 %
at 5th month
Telogen Anagen
© Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I
HAIR DIAMETER
18
63
64
65
66
67
68
69
70
71
72
Baseline Month-5
66.25
72
HairDiameterinuM
Effect of Kopexil Aqua Hair Diameter
8.6 %
Kopexil Aqua increases the hair diameter by 9 % at month 5, hence helps to increase
the hair volume
© Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I
Consumer Perceptions for Kopexil Aqua’s efficacy
19
Question Responses Month 1 Month 2 Month 5
Bald 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
© Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I
20
Product’s
Name
Hair density
(%)
Hair
diameter
Hair
growth
rate
Anagen/Teloge
n 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
© Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I
Major benefits/Claims of Kopexil Aqua
21
Kopexil Aqua
100 % Water soluble,
No dry scalp, dandruff,
itchy-ness
Activates the
active phase
of hair
Accelerates
hair growth
Potent 5α
reductase
inhibitor
Increases
Hair density
Strong anti-
oxidant
PATENT PENDING “WATER SOLUBLE COMPOSITIONS FOR REATING HAIR LOSS & PROMOTING HAIR GROWTH”
Active registered in Pre REACH registration
© Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I
22
Product Launched
1st product launched by Green laboratory Europe
© Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I
New upcoming Products
 Pullulan- A multifunctional bioingredient,1st Indian manufacturer
L3 (Lauryl Lactyl lactate)- A secondary mild surfactant
 EHG (Ethyl hexyl glycerine)- Preservative and skin conditioners
23
© Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I
Thank You
24

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Kopexil aqua- 100 % water soluble hair growth stimulant

  • 1. © Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I KUMAR ORGANICS WELCOMES FOR PRESENTATION ON 1 Presented By Dr Ramkrishna Gupta Global Technical Head Kopexil Aqua-A clinically proven 100 % water soluble Hair growth stimulant Clinical study No.: ICB1101KOP02IP02P2
  • 2. © Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I Why Hair is Important 2 Kareena Kapoor-Top Bollywood actress Although Hair is dead tissue, but play a very important role to enhance the beauty
  • 3. © Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I 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. 3
  • 4. © Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I • 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 4
  • 5. © Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I 5 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.
  • 6. © Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I FDA approved hair growth stimulants 6 • 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.
  • 7. © Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I Do you want to be free from dandruff, itchy scalp, irritation due to alcohol based hair growth stimulant products??? Then try Kopexil Aqua 7 Kopexil Aqua
  • 8. © Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I Solutions Hair loss 8 4Hair Loss prevention Men & Women AQUAPRODUCTS PATENT PENDING “WATER SOLUBLE COMPOSITIONS FOR REATING HAIR LOSS & PROMOTING HAIR GROWTH”
  • 9. © Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I Efficacy Studies 9 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
  • 10. © Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I DHT Release assay • In-Vitro study was conducted in DU-145 (human prostate cancer) cells because having DHT-R 10 Kopexil Aqua is potent molecule to reverse the effect of Testosterone on DHT release
  • 11. © Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I Effect of Kopexil Aqua on SHH gene activation 11 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
  • 12. © Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I Clinical Study 12
  • 13. © Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I Clinical Efficacy evaluation of Kopexil Aqua- A POP study •A- Minoxidil 5 % •B. Kopexil Aqua 3 % (active content 1.5 %) 13 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:
  • 14. © Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I 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 14
  • 15. © Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I 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 15 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.
  • 16. © Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I Effect of Kopexil Aqua on Hair Density 16 *indicates that p value is <0.05 when compared from baseline % improvement at month 2, month 4 and month 5 0 2 4 6 8 10 12 14 Baseline Month-5 MeanScore Effect of Kopexil Aqua on Hair Density 69 % Kopexil Aqua increases the hair density by 69 % at month 5 Baseline Fifth Month
  • 17. © Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I Anagen telogen ratio (A/T ratio) 17 *indicates that p value is <0.05 when compared from baseline % improvement at month 2, month 4 and month 5 0 2 4 6 8 10 Baseline Month-5 MeanScore Effect of Kopexil Aqua on Anagen/Telogen Ratio 29 % Kopexil Aqua activates the Anagen phase of hair cycle and increases the A/T ratio by 29 % at 5th month Telogen Anagen
  • 18. © Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I HAIR DIAMETER 18 63 64 65 66 67 68 69 70 71 72 Baseline Month-5 66.25 72 HairDiameterinuM Effect of Kopexil Aqua Hair Diameter 8.6 % Kopexil Aqua increases the hair diameter by 9 % at month 5, hence helps to increase the hair volume
  • 19. © Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I Consumer Perceptions for Kopexil Aqua’s efficacy 19 Question Responses Month 1 Month 2 Month 5 Bald 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
  • 20. © Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I 20 Product’s Name Hair density (%) Hair diameter Hair growth rate Anagen/Teloge n 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
  • 21. © Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I Major benefits/Claims of Kopexil Aqua 21 Kopexil Aqua 100 % Water soluble, No dry scalp, dandruff, itchy-ness Activates the active phase of hair Accelerates hair growth Potent 5α reductase inhibitor Increases Hair density Strong anti- oxidant PATENT PENDING “WATER SOLUBLE COMPOSITIONS FOR REATING HAIR LOSS & PROMOTING HAIR GROWTH” Active registered in Pre REACH registration
  • 22. © Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I 22 Product Launched 1st product launched by Green laboratory Europe
  • 23. © Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I New upcoming Products  Pullulan- A multifunctional bioingredient,1st Indian manufacturer L3 (Lauryl Lactyl lactate)- A secondary mild surfactant  EHG (Ethyl hexyl glycerine)- Preservative and skin conditioners 23
  • 24. © Confidential I Kumar Organic Products Ltd. I www.kumarorganic.net I Thank You 24

Editor's Notes

  1. KOPDIL (Minoxidil) is the only treatment for Male patterned and Female patterned (AGA) hair loss that has been approved by FDA (American Food and Drug Administration) and has extensive, recognized clinical trials carried out. It is also medically and scientifically proven to stabilize genetic hair loss and stimulate renewed hair growth. History: Minoxidil was originally developed in the early 1970’s as a treatment for hypertension. Its use for treating thinning hair was originally discovered when it was noted to cause increased hair growth as a side effect of this treatment. Since 1998, Topical Minoxidil is the most widely recommended treatment for androgenetic alopecia. air Growth Stimulant