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Dr. Klein's Formula
Prescription Strength Hair Growth Trial
Hair Loss Treatment Study - courtesy of Dr. Klein's Formula
Clinical Trial for the Treatment of Androgenetic Alopecia—
Local Application of Combined Minoxidil and Finesteride Formula
Introduction
Alopecia or hair loss is a chronic skin disorder characterized by loss of some or all of the hair from the scalp and sometimes from the other parts of the body as well. It occurs in various patterns and affects both males and females. The most common type of baldness is male-pattern baldness, also called androgenetic alopecia. It is characterized by a defined pattern of hair loss from the top of the scalp and regression of the hairline. It affects a large proportion of the population. It might start as early as adolescence and increase with age. In the white population, males in their fifties have a 50% chance of exhibiting some degree of androgenetic alopecia as against an overall average of 66%.1
Genetic and endocrinal factors play an important role but the exact cause and mechanism of hair loss is not clearly understood.2
Alopecia, except for mild itching in some cases, is not a painful or life threatening condition. It may affect the psychological wellbeing of the victim. Studies in this regard are not very exhaustive. They suggest that baldness is psychologically damaging and can cause intense emotional disturbance. It can lead to personal social and job-related problems.3 Hair has always been an important aspect of one’s image or identity particularly for women.4 Among the women suffering from alopecia, around 40% experienced marital problems and 63% suffered career related problems.5 Over all such people feel more social discomfort, and suffer from low self-esteem. In more than 30% of the cases specific problems are attributed to hair loss.6
A study revealed that males who had more profound hair loss were more dissatisfied with their appearance and were more concerned with their older look than those with minimal hair loss. This effect cut across all age groups but was more prominent in the younger age group.7
Difficulties in treatment
Androgenetic alopecia is a poorly understood progressive condition. Androgenic hormones are involved in its pathophysiology. This renders treatment difficult and complex. The androgen receptor antagonists used to treat women are not suitable for men because of the potential risks of gynaecomastia, feminisation, and impotence. In the absence of an understanding of the pathophysiology, it is not possible to attack specific areas.
There are four options for androgenic alopecia available to the patient: 8
1. no treatment
2. medical therapy
3. using a wig
4. surgical treatment
Each of these has its own advantages and disadvantages. As far as medical treatment is concerned, the two that are approved by the FDA in the USA for the treatment of androgenetic alopecia in men are:
1. Topical minoxidil
2. Oral finasteride
Minoxidil is an oral antihypertensive drug which has a side effect of excessive hair growth. It is used topically to treat baldness. Though it results in hair growth in most patients, the hair grown is generally indeterminate rather than true terminal hair. The hair sheds when treatment is stopped.9 Its main benefit is in arresting the progression of balding.
Finasteride is a potent 5áreductase type 2 inhibitor.10 Its main action is to lower circulating dihydrotestosterone by inhibiting its production by the prostate, rather than affecting the metabolism of the androgen in the hair follicle. Loss of libido is one of the important side effects of this oral therapy.
Synergistic effect of the local application of minoxidil finasteride
1. In view of the different mechanisms of action, it was hypothesized that the simultaneous administration of both the molecules should have a synergistic action.
2. The side effects associated with the oral administration would also be reduced.
3. If the dosage of the individual drug could be reduced, it will further improve the safety profile of the therapy.
Clinical Study
The effect of the novel combination was observed in a study. The subjects were divided into three groups.
Group I (Placebo Group) plain lotion was applied
Group II (Minoxidil Group) 5% Minoxidil lotion was applied
Group III (Combination Group) 5% Minoxidil lotion, 0.025% Tretinoin and 0.1% Finesteride were applied.
The important aspect of the study was the fact that none of the parties involved viz. the clinical / research staff, the study sponsors or the subjects in the three groups were aware of the various groups until the data was collected in the verified database.
The subjects were evaluated every six months with the help of a subjective questionnaire, objective examination and close-up photographs.
Results
In the Placebo Group, there was neither any improvement nor deterioration. In the Minoxidil Group 25% of the subjects showed hair growth. In the Combination Group as much as 75% of the subjects showed improvement. Further, the quality of the newly grown hair was also better in the combination group.
Combination Therapy
| Group | Success Rate |
| Group I (Placebo Group) plain lotion was applied | 0% |
| Group II (Minoxidil Group) 5% Minoxidil lotion was applied | 25% |
| Group III (Combination Group) 5% Minoxidil lotion, 0.025% tretinoin and 0.1% Finesteride were applied. | 75% |
Discussion
This study indicates that simultaneous application of topical Minoxidil and Finasteride leads to a statistically significant improvement in hair growth. Combination therapy was almost three times as effective as any one of the control groups. These results were documented in a triple-blind clinical trial using a subjective questionnaire, objective examination and close-up photographs. The findings are statistically significant. The study design and objective evaluation rule out observer bias, a common source of error in clinical trials. The two drugs have different mechanisms of action and combined use allows for a synergistic effects that are not possible in either drug if administered individually. It may also be possible to reduce the dose of each drug, decreasing any potential side-effects.
Conclusion
Simultaneous application of topical Minoxidil and Finasteride formula shows great promise in the treatment of Alopecia androgenetica with the possibility of lower risk of side effects or complications.
References
1. Hamilton JB. Patterned loss of hair in man: Types and incidence. Ann NY Acad Sci 1951; 53:708-11.
2. Anjiki T, Suzuki S. An injection-corrosion study on the angioarchitecture of the rat skin. Jikken Dbutsu. 1991; 40(4):439-46.
3. Hunt N, McHale S. Reported experiences of persons with alopecia areata. J Loss Trauma 2005;10: 33-50.
4. Weitz R. Rapunzel's daughters: what women's hair tells us about women's lives. New York: Farrar, Straus, and Giroux, 2004.
5. Hunt N, McHale S. Understanding alopecia. London: Sheldon, 2004.
6. Passchier J, Donk JV, Dutree-Meulenenberg PO, Verhage F. Psychological Characteristics of Men With Alopecia Androgenetica and Effects of Treatment With Topical Minoxidil An Exploratory Study. International Journal of Dermatology.1988:27(6):441-446.
7. Girmana CJ, Rhodesa T, Lillyb FR, Guob SS, Siervogelb RM, Patrickc DL, Chumleab WC. Effects of Self-Perceived Hair Loss in a Community Sample of Men. Dermatology 1998;197:223-229
8. Sinclair R. Fortnightly review: Male pattern androgenetic alopecia. BMJ. 1998;317;865-869
9. Olsen EA,Weiner MS. Topical minoxidil in male pattern baldness: effects of discontinuation of treatment. J Am Acad Dermatol 1987;17:97101.
10.Olsen E. Finasteride (1 mg) in the treatment of androgenetic alopecia in men . Aust J Dermatol 1997;38;A316.