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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
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.