Hairloss PI

Archive for the ‘Topical Scalp Treatments’ Category

Viviscal is a hair supplement which has received broad attention as a  hair loss and balding treatment far beyond what it deserves.

It has received this attention in part because it has been misrepresented in the media by the likes of Tabatha Coffey and Dr. Oz, to mention but a few.

Whether this misrepresentation has been the intentional marketing goal of the organisation behind Viviscal, I cannot say, however when you read the fine print on the Viviscal website, it makes it abundantly clear that this product CANNOT and DOES NOT treat male pattern baldness or female pattern hair loss, or any other genetic hair loss conditions.

The Viviscal website states the following:

"These products are not intended to diagnose, treat, cure or prevent any disease."

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Minoxidil, Finasteride and Low Level Laser Therapy are the ONLY three FDA-approved, clinically-proven hair loss treatments on the market today.

The most well-known product name for Minoxidil is Rogaine, which contains both Minoxidil and the treatment vehicle, called propylene glycol, which helps the Minoxidil get absorbed into the skin.

Rogaine originally came in 2% strength, but now is more commonly sold at 5%. A 12.5% version called Xandrox is also available.

Although Rogaine has been claimed to help up to 85% of men using this topical lotion, it also has developed a reputation for complications that forced many men to stop using the product, for reasons unrelated to the effectiveness of the product in hair maintenance or regrowth.

For many men, the application of Rogaine left already brittle hair saggy and greasy, cosmetically making the user look more 'bald' than he otherwise looked.

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I wrote in an earlier post about a study suggesting that topical ketoconazole increases hair growth in mice (Nizoral) through an unknown mechanism. As interesting as rodent studies can be, the truth is that nothing beats experiments done on humans. That's especially true of hair growth studies.

Luckily, I found an old paper by Piérard-Franchimont et al. who compared the effects of topical ketoconazole to ordinary shampoos and minoxidil on people suffering from hair loss. Ketoconazole is the active ingredient in Nizoral, which is available as 1% and 2% strength. The latter was the one used in the study. Since the study included two separate experiments, I'm going to concentrate on the first one in this post and discuss the second one later.

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Male pattern hair loss (MPHL) is a condition that affects as many as 50 percent of men by the age of fifty, but according to a new study, baldness may soon be a treatable condition.

Using pairs of identical twins, the study assessed the efficacy of dutasteride, a particular enzyme inhibitor, as a means of reducing hair loss and encouraging new growth, finding it to be an effective means of combating baldness.

In the study, one of each pair of twins was given 0.5 mg/day of the medication, the other receiving a placebo, with the results monitored over the course of a year. After both 6 and 12-month intervals, hair loss was found to not only have been halted in twins using dutasteride, but hair growth was actively improved. The rate of growth increased between the 6 and 12-month evaluations, while hair loss continued steadily in the placebo group.

MPHL is thought to be genetically controlled. As identical twins share the same genetic code, the study provides particularly convincing evidence of the efficacy of dutasteride.

Introduction

Alopecia or hairloss 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 hairloss 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 hairloss 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 hairloss.⁶

A study revealed that males who had more profound hairloss were more dissatisfied with their appearance and were more concerned with their older look than those with minimal hairloss. 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 5á reductase 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. 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.

Study Participant:

Discussion

This study indicates that topical application of Minoxidil and Finasteride leads to better hair growth. Combination therapy was thrice as effective as any one of them. 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 route of action and combined use allows for a dual action. It may also be possible to reduce the dose of each drug, decreasing their individual side-effects.

Conclusion

A combination therapy of Minoxidil and Finasteride shows great promise in the treatment of hitherto difficult condition Alopecia androgenetica. It may potentially become the main stay therapy in this condition.

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 Hairloss 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;17:97 101.
10. Olsen E. Finasteride (1 mg) in the treatment of androgenetic alopecia in men . Aust J Dermatol 1997;38;A316.

With so many products on the market claiming to stop hair loss, it’s no wonder that confusion abounds. And with the high stakes involved in this multi-billion dollar industry, the public is constantly being bombarded with marketing messages ranging from pills and topical applications to hair transplants.

Now entering into the ring is relative newcomer, FDA approved Caproxen, offering a viable solution to waning confidence and self-esteem due to hair loss for those on a tight budget.

According to Caproxen, “Now you don’t have to spend thousands of dollars on hair transplants, worry about wigs, or take those pills that simply don’t work. Order today if you want our professional grade formula to start growing your hair and confidence back.”

Among the 40 million men suffering from hereditary hair loss in the US alone, Caproxen users claim to have experienced noticeable results shortly after using the product and Caproxen is apparently backing up their claim with an unheard of offer.

Caproxen is currently offering to send a bottle, for the $5.95 cost of shipping, to anyone wanting to experience the results for themselves.

So if you’re among the 40 million men in the US currently suffering from male pattern baldness, consider taking advantage of Caproxen’s $5.95 offer before you make an appointment for an expensive hair restoration operation or other alternatives.