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RESULTS AND EVIDENCE
OF TOPICAL COMBINATION
OF MINOXIDIL AND
FINASTERIDE IN AGA
Dr. ……………………..
AGA: EPIDEMIOLOGY
In the Indian context, a prevalence
rate of 58% in males aged 30–50
years has been found.
In all cases, the incidence
gradually increases with age.
In women, epidemiological data
are scarce.
Int J Trichology. 2019 May-Jun; 11(3): 101–10
COMPLEX ETIO-PATHOGENESIS
OF AGA
The major factor involved in the pathogenesis of
AGA is the undesirable androgen metabolism at
the hair follicle level.
Elevated activity of Type II isoform of the 5-
alpha reductase (5AR) enzyme, which
metabolizes testicular testosterone.
Follicular micro inflammation
Oxidative stress
Prostaglandin imbalance
TREATMENT: MEDICAL
TREATMENT
Minoxidil
5-alpha reductase inhibitors
Recommendation: Finasteride should be given
for at least 6–12 months
Hormonal treatment
Platelet-rich plasma
Hair transplantation
Int J Trichology. 2019 May-Jun; 11(3): 101–10
CHALLENGES IN THE
MANAGEMENT OF AGA
Limitation of therapy which is affecting
patient compliance:
Topical Minoxidil: Alcohol content leads to
scalp irritation
Oral Finasteride: Systemic side-effects
Hormonal treatment: Systemic side-effects
Platelet-rich plasma: Time-consuming and
painful procedure
Hair transplantation: Costly and need long-
term compliance
Patient compliance is also a major challenge in the management of AGA
RECOMMENDATIONS FOR
IMPROVEMENT OF PATIENT
COMPLIANCE
Only recommending treatments that are effective in circumstances
Prescribing the minimum number of different medications, e.g.,
combining active ingredients into a single compound
Simplifying dosage regimen by selecting different treatment or using
a preparation that needs fewer doses during the day
Selecting treatments with lower levels of side effects or fewer
concerns for long-term risks
Discussing possible side effects and whether it is important to
continue medication regardless of those effects
Advice on minimizing or coping with side effects
Regular follow-up for reassurance on drug safety and treatment
benefits
Developing trust so patients don’t fear embarrassment or anger if
unable to take a particular drug, allowing the doctor to propose a more
acceptable alternative
Guide to Successful Management of Alopecia and Related Conditions, DOI 10.1007/978-3-319-19701
LIMITATION OF TOPICAL
MINOXIDIL MONOTHERAPY
Doesn’t act on the actual pathology of AGA
Low Response rate (30-40% patients)
If used as a monotherapy in higher dose leads to more scalp irritation
This limitations and complex etiopathology
warrants combination therapy
MEDICAL NEED OF
COMBINATION
8
Topical
Minoxidil
Oral
Finasteride
Androgenic side effects
systemic absorption
•Impotence
•Loss of Libido
•Decreased ejaculation
•Enlargement of breast
Because of these side effects associated with
oral finasteride… Dr’s have reservation in Rxing
Finasteride to their patients
CONCERN OF ORAL
FINASTERIDE
9
Oral Finasteride
To overcome Dr’s reservation
affiliate
Finasteride & Minoxidil
Topical Formulation
10
BENEFITS OF TOPICAL
FINASTERIDE
11
40% more scalp DHT
reduction than Oral
Finasteride
Topical Finasteride
Int J Clin Pharmacol Ther. 2014 Oct;52(10):842-9.
BENEFITS OF TOPICAL
FINASTERIDE
12
• Minimal Plasma
concentration
Topical Finasteride
14 Fold
Safety
Int J Clin Pharmacol Ther. 2014 Oct;52(10):842-9.
CLINICAL EVIDENCES ON
TOPICAL FINASTERIDE
1. Topical vs Oral Finasteride
 2. Topical Minoxidil vs FDC (Topical minoxidil +
finasteride) in AGA
Intas-Morr F: Phase III clinical trial
Randomized double blind trial published in European journal
3. Topical Minoxidil vs FDC (Topical minoxidil +
finasteride) in FPHL
Switch from oral to topical finasteride with Minoxidil
1. TOPICAL VS ORAL
FINASTERIDE
Int J Res Dermatol. 2018 Aug;4(3):386-39
RESULTS
50 patients of stage III and
IV of Hamilton-Norwood scale
were randomly assigned to
either
Group A receiving topical 5%
minoxidil and oral finasteride 1
mg
Group B receiving topical 5%
minoxidil and topical 0.1%
finasteride.
Int J Res Dermatol. 2018 Aug;4(3):386-39
SIDE EFFECTS: ORAL(A) VS
TOPICAL(B) FINASTERIDE
Int J Res Dermatol. 2018 Aug;4(3):386-39
17
Technologically advanced Formulation
USFDA Approved Lipid:
Soy Phosphatidylcholine
• Enhances penetration
• Improves drug solubility
• Help forming reservoir that prolongs the penetration
•Act as a Natural Lipid
MINOXIDIL AND FINASTERIDE
COMBINATION
(MORR F): ADVANCED FORMULATION
2.1 MINOXIDIL & FINASTERIDE
COMBINATION: PHASE III
CLINICAL TRIAL
J Clin Exp Dermatol Res 2015, 6
2.1 MINOXIDIL AND FINASTERIDE
COMBINATION (MORR F): PHASE
III CLINICAL TRIAL
GLOBAL PHOTOGRAPHIC
ASSESSMENT
HAIR DENSITY
HAIR DIAMETER
METHOD AND
RESULTS
J Clin Exp Dermatol Res 2015,
Significantly more patients treated
with MorrF showed greater
improvement in Investigator score
(65% vs. 26%), global
photographic assessment (89% vs.
60%) and patient’s self-assessed
questionnaire as compared to
Minoxidil alone.
Patients were randomized to
receive either MorrF or Minoxidil
(5%) alone for 24 weeks.
2.2. A RANDOMIZED, DOUBLE-BLIND
CONTROLLED STUDY PUBLISHED IN
EUROPEAN JOURNAL
J Eur Acad Dermatol Venereol. 2018 Dec;32(12):2257-22
24 weeks of treatment with a finasteride/minoxidil or minoxidil solution twice daily
J Eur Acad Dermatol Venereol. 2018 Dec;32(12):2257-22
Treatment with topical finasteride admixed with 3% minoxidil was significantly superior
to 3% minoxidil solution for promoting hair growth in male androgenetic alopecia, and
well tolerated.
3. TOPICAL COMBINATION IN
FPHL
This was a prospective, randomized, double-blind study in 30 postmenopausal women with
FPHL
Am J Clin Dermatol. 2019 Feb;20(1):147-1
By 24 weeks, hair density and diameter had increased in finasteride/minoxidil and it was
significantly superior to minoxidil solution in terms of hair diameter (p = 0.039). No systemic
side effects were reported.
Am J Clin Dermatol. 2019 Feb;20(1):147-1
4. SWITCH FROM ORAL TO
TOPICAL FINASTERIDE WITH
MINOXIDIL
Indian Dermatol Online J. 2015 Jan-Feb;6(1):17
4. SWITCH FROM ORAL TO
TOPICAL FINASTERIDE WITH
MINOXIDIL
Of the 45 patients who underwent a continuous treatment for AGA, 84.44%
maintained a good hair density with topical minoxidil-finasteride
combination.
Patients who discontinued oral finasteride for 8-12 months, 80%
demonstrated good improvement in hair density when treatment was
resumed with topical minoxidil-finasteride combination.
Indian Dermatol Online J. 2015 Jan-Feb;6(1):17
Topical finasteride can be considered for hair density maintenance after initial
improvement with oral finasteride, thereby obviating the indefinite use of oral
finasteride.
In India, prevalence rate of 58% in males aged 30–50 yrs.
Complex etiopathology warrants combination therapy
Topical finasteride has better scalp DHT reduction with
minimal Plasma concertation.
Topical finasteride/minoxidil is significantly superior to
minoxidil solution in terms of-
Hair density/hair count
as well as global photographic assessment.
THANK YOU

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Results and evidence of Topical combination of minoxidil and finasteride....pptx

  • 1. RESULTS AND EVIDENCE OF TOPICAL COMBINATION OF MINOXIDIL AND FINASTERIDE IN AGA Dr. ……………………..
  • 2. AGA: EPIDEMIOLOGY In the Indian context, a prevalence rate of 58% in males aged 30–50 years has been found. In all cases, the incidence gradually increases with age. In women, epidemiological data are scarce. Int J Trichology. 2019 May-Jun; 11(3): 101–10
  • 3. COMPLEX ETIO-PATHOGENESIS OF AGA The major factor involved in the pathogenesis of AGA is the undesirable androgen metabolism at the hair follicle level. Elevated activity of Type II isoform of the 5- alpha reductase (5AR) enzyme, which metabolizes testicular testosterone. Follicular micro inflammation Oxidative stress Prostaglandin imbalance
  • 4. TREATMENT: MEDICAL TREATMENT Minoxidil 5-alpha reductase inhibitors Recommendation: Finasteride should be given for at least 6–12 months Hormonal treatment Platelet-rich plasma Hair transplantation Int J Trichology. 2019 May-Jun; 11(3): 101–10
  • 5. CHALLENGES IN THE MANAGEMENT OF AGA Limitation of therapy which is affecting patient compliance: Topical Minoxidil: Alcohol content leads to scalp irritation Oral Finasteride: Systemic side-effects Hormonal treatment: Systemic side-effects Platelet-rich plasma: Time-consuming and painful procedure Hair transplantation: Costly and need long- term compliance Patient compliance is also a major challenge in the management of AGA
  • 6. RECOMMENDATIONS FOR IMPROVEMENT OF PATIENT COMPLIANCE Only recommending treatments that are effective in circumstances Prescribing the minimum number of different medications, e.g., combining active ingredients into a single compound Simplifying dosage regimen by selecting different treatment or using a preparation that needs fewer doses during the day Selecting treatments with lower levels of side effects or fewer concerns for long-term risks Discussing possible side effects and whether it is important to continue medication regardless of those effects Advice on minimizing or coping with side effects Regular follow-up for reassurance on drug safety and treatment benefits Developing trust so patients don’t fear embarrassment or anger if unable to take a particular drug, allowing the doctor to propose a more acceptable alternative Guide to Successful Management of Alopecia and Related Conditions, DOI 10.1007/978-3-319-19701
  • 7. LIMITATION OF TOPICAL MINOXIDIL MONOTHERAPY Doesn’t act on the actual pathology of AGA Low Response rate (30-40% patients) If used as a monotherapy in higher dose leads to more scalp irritation This limitations and complex etiopathology warrants combination therapy
  • 9. Androgenic side effects systemic absorption •Impotence •Loss of Libido •Decreased ejaculation •Enlargement of breast Because of these side effects associated with oral finasteride… Dr’s have reservation in Rxing Finasteride to their patients CONCERN OF ORAL FINASTERIDE 9 Oral Finasteride
  • 10. To overcome Dr’s reservation affiliate Finasteride & Minoxidil Topical Formulation 10
  • 11. BENEFITS OF TOPICAL FINASTERIDE 11 40% more scalp DHT reduction than Oral Finasteride Topical Finasteride Int J Clin Pharmacol Ther. 2014 Oct;52(10):842-9.
  • 12. BENEFITS OF TOPICAL FINASTERIDE 12 • Minimal Plasma concentration Topical Finasteride 14 Fold Safety Int J Clin Pharmacol Ther. 2014 Oct;52(10):842-9.
  • 13. CLINICAL EVIDENCES ON TOPICAL FINASTERIDE 1. Topical vs Oral Finasteride  2. Topical Minoxidil vs FDC (Topical minoxidil + finasteride) in AGA Intas-Morr F: Phase III clinical trial Randomized double blind trial published in European journal 3. Topical Minoxidil vs FDC (Topical minoxidil + finasteride) in FPHL Switch from oral to topical finasteride with Minoxidil
  • 14. 1. TOPICAL VS ORAL FINASTERIDE Int J Res Dermatol. 2018 Aug;4(3):386-39
  • 15. RESULTS 50 patients of stage III and IV of Hamilton-Norwood scale were randomly assigned to either Group A receiving topical 5% minoxidil and oral finasteride 1 mg Group B receiving topical 5% minoxidil and topical 0.1% finasteride. Int J Res Dermatol. 2018 Aug;4(3):386-39
  • 16. SIDE EFFECTS: ORAL(A) VS TOPICAL(B) FINASTERIDE Int J Res Dermatol. 2018 Aug;4(3):386-39
  • 17. 17 Technologically advanced Formulation USFDA Approved Lipid: Soy Phosphatidylcholine • Enhances penetration • Improves drug solubility • Help forming reservoir that prolongs the penetration •Act as a Natural Lipid MINOXIDIL AND FINASTERIDE COMBINATION (MORR F): ADVANCED FORMULATION
  • 18. 2.1 MINOXIDIL & FINASTERIDE COMBINATION: PHASE III CLINICAL TRIAL J Clin Exp Dermatol Res 2015, 6
  • 19. 2.1 MINOXIDIL AND FINASTERIDE COMBINATION (MORR F): PHASE III CLINICAL TRIAL
  • 23. METHOD AND RESULTS J Clin Exp Dermatol Res 2015, Significantly more patients treated with MorrF showed greater improvement in Investigator score (65% vs. 26%), global photographic assessment (89% vs. 60%) and patient’s self-assessed questionnaire as compared to Minoxidil alone. Patients were randomized to receive either MorrF or Minoxidil (5%) alone for 24 weeks.
  • 24. 2.2. A RANDOMIZED, DOUBLE-BLIND CONTROLLED STUDY PUBLISHED IN EUROPEAN JOURNAL J Eur Acad Dermatol Venereol. 2018 Dec;32(12):2257-22 24 weeks of treatment with a finasteride/minoxidil or minoxidil solution twice daily
  • 25. J Eur Acad Dermatol Venereol. 2018 Dec;32(12):2257-22 Treatment with topical finasteride admixed with 3% minoxidil was significantly superior to 3% minoxidil solution for promoting hair growth in male androgenetic alopecia, and well tolerated.
  • 26. 3. TOPICAL COMBINATION IN FPHL This was a prospective, randomized, double-blind study in 30 postmenopausal women with FPHL Am J Clin Dermatol. 2019 Feb;20(1):147-1
  • 27. By 24 weeks, hair density and diameter had increased in finasteride/minoxidil and it was significantly superior to minoxidil solution in terms of hair diameter (p = 0.039). No systemic side effects were reported. Am J Clin Dermatol. 2019 Feb;20(1):147-1
  • 28. 4. SWITCH FROM ORAL TO TOPICAL FINASTERIDE WITH MINOXIDIL Indian Dermatol Online J. 2015 Jan-Feb;6(1):17
  • 29. 4. SWITCH FROM ORAL TO TOPICAL FINASTERIDE WITH MINOXIDIL Of the 45 patients who underwent a continuous treatment for AGA, 84.44% maintained a good hair density with topical minoxidil-finasteride combination. Patients who discontinued oral finasteride for 8-12 months, 80% demonstrated good improvement in hair density when treatment was resumed with topical minoxidil-finasteride combination. Indian Dermatol Online J. 2015 Jan-Feb;6(1):17 Topical finasteride can be considered for hair density maintenance after initial improvement with oral finasteride, thereby obviating the indefinite use of oral finasteride.
  • 30. In India, prevalence rate of 58% in males aged 30–50 yrs. Complex etiopathology warrants combination therapy Topical finasteride has better scalp DHT reduction with minimal Plasma concertation. Topical finasteride/minoxidil is significantly superior to minoxidil solution in terms of- Hair density/hair count as well as global photographic assessment.