A. Lassus*, J. Santalahti*, M. Sellmann**
*Helsinki Research Center - Stora Roberts-Gatan 8 A 1, FIN-00120 Helsinki, Finland
** Dermatological clinic - Friedrich-Ebert-Platz 17, 51373 Leverkusen, Germany

 SUMMARY

 30 middle-aged males with hereditary androgenic alopecia were treated for eight months with compound of marine extract Viviscal®. The preparation was administered orally in tablet form (2-3 tablets daily), and topically applied in form of hair lotion and shampoo. The results were evaluated by measurement of the bald areas, photography, ultrasound measurements, elasticity index and the erythemal index of the skin. The study showed that Viviscal® had a substantial effect on hair loss and in most patients on regrowth of permanent hair in the bald areas. No adverse effects were observed except some drying of the skin of the scalp in all patients. The results are impressive, considering the rather high average age of the test group.

 INTRODUCTION

 Throughout history men have concocted various potions from animal, vegetable and mineral substances in an attempt to improve hair growth and at the present time hair transplants and scalp reductions are used to minimise visible alopecia. The results of surgical procedures are, however, not always cosmetically acceptable. An alternative approach is the use of pharmaceutical preparations. Minoxidil, a piperidinopyrimidine derivative, is a potent peripheral vasodilator. 

Recent trials using topical minoxidil have shown that it has a stimulatory effect on hair regrowth in some individuals with either androgenic alopecia or alopecia areata^(1,2). 

Recently it was shown in double-blind study that a new compound derived from marine fish had a good effect in early male pattern baldness in young males when given orally⁽³⁾. In the present study on older population with male pattern baldness received both oral and topical treatment with the same active substance. 

MATERIAL AND METHODS

 Patients
A total of 30 males with hereditary androgenic alopecia classified on the Hamilton scale⁽⁴⁾ as II - IV took part in the study. The clinical data of the patients are presented in Table 1. The mean age was 40 years (range 34 - 48) and the mean duration of hair loss 11 years (range 3 - 20). Twenty-five of them had earlier been treated with topical Minoxidil and/or photochemotherapy with no or minimal response. Seven were heavy smokers (20 cigarettes or more per day) and four smoked only occasionally. All 30 subjects were in good health and did not use concomitant medication. Before treatment oral informed consent was obtained from all patients. 

Treatment design
All patients were treated for eight months. The oral dose of Viviscal® depended on the body weight (2 tablets daily if <80kg and 3 tablets daily if>80kg). In addition, Viviscal® lotion was rubbed onto the bald areas every evening and the hair was washed with Viviscal® shampoo 2-3 times/week (both lotion and shampoo contain 1% of the same active ingredients as the tablets). Clinical evaluations were carried out at baseline and thereafter bi-monthly for eight months. At each visit the patients were asked for severity of hair loss and possible adverse reactions. Before start of treatment and at each later visit the total cumulative areas of baldness were measured as square centimetres and expressed as a percentage of the total scalp area. In addition, a photography of the scalp was taken at each visit. At baseline and each later visit, the epidermal and dermal thickness was measured with a Dermascan-C equipment and an elasticity index was determined using a Dermaflex-A equipment (Cortex Ltd., Denmark) ^(5,6). An erythermal index was measured using an erythemal meter (Diastron Ltd., UK) ⁽⁷⁾. All measurements were carried out in the same site of the scalp. 

For statistical analysis, the student's T-test was used. 


RESULTS

 The clinical results of the treatment are shown in Table 2. At baseline 12 patients estimated the hair loss as severe, 5 as moderate and 13 as mild. After two months of treatment the hair loss had stopped in all subjects. Prior to the study, the mean area of baldness of the total scalp was 39% (11 - 52%) and after end of treatment 9% (4 - 25%). Thirteen patients showed total regrowth (43%), seven >75% regrowth (23%), four 50 - 75% regrowth (13%), another four 30 - 50% regrowth and two (7%) patients no regrowth. Five of the six patients with poor results were heavy smokers. Eighteen patients (60%) developed an increased growth of their beard and two increase of chest hair during the treatment period. These were all good responders to the treatment. 

The increase of epidermal and dermal thickness is shown in Table 3. Both layers of the skin became significantly thicker. Also the elasticity index as well as the erythemal index increased significantly. At baseline the heavy smokers had a mean lower erythemal index (0.139) as compared with the whole group (0.209) and the increase was less (mean 0.187) after treatment as compared with that of the whole series (0.306). 

All patients experienced a mild to moderate dying of the scalp during treatment. No further adverse reactions were reported or observed. 

DISCUSSION

 The results of the present study confirm the results presented earlier⁽³⁾, that Viviscal® is effective in the treatment of hereditary androgenic alopecia. However, in the present trial the study population was significantly older with a much longer duration of baldness. The study design was also different, as the oral dose given was higher in heavier subjects and topical treatment was used simultaneously and the treatment period was longer. It was also of interest that the treatment seemed to effect hair growth in the face and on the chest in some individuals. 

The mechanism by which Viviscal® stimulates regrowth of hair is still unclear. Nutritional factors are probably of importance, but there are still other effects which remain unknown. Theoretically one may speculate that the active substances can have a blocking effect on the androgenic receptors in the papilla. Simultaneous topical treatment seems to be of importance, both as a nutritional factor and by increase in capillary circulation as shown by the increase of the erythemal index. This is further stressed by the observation that heavy smokers responded less well. Oral treatment alone does not cause vasodilation⁽³⁾. 

In conclusion, Viviscal® seems to be effective in the treatment of androgenic alopecia in both young and middle-aged males. The weight-dependent dosing of the oral treatment and the combination with topical treatment may be the most efficient mode of using Viviscal®.

REFERENCES

 1) Olsen EA., Weiner MS, Delong ER., Pinnel SR. et al. Topical minoxidil in early male pattern baldness. J. Am. Acad. Dermatol. 1985; 13: 185-192.
2) Weiss VC., West FP., Fu TS., Robinson LA. Et al. Alopecia areata treated with topical minoxidil. Arch. Dermatol. 1984; 120:457-463.
3) Lassus A., Eskelinen E. A comparative study of a new food supplement, Viviscal(r), with fish extract for the treatment of hereditary androgenic alopecia in young males. J. Int. Med. Res 1992; 20: 445-453.
4) Hamilton JB. Patterned loss of hair in man: types and incidences. Ann. NY. Acad. Sci 1951; 53:708-711.
5) Serup J., Holm P., Stender IM. Et al. Skin atrophy and telangiectasia after topical corticosteroids as measured non-invasively with high frequency ultrasound, evaporimetry and laser flowmetry: methological aspects including evaluations of regional differences. Bioeng. Skin 1987; 3: 43-58.
6) Serup J., Northeved A. Skin elasticity in psoriasis. In vivo measurement of tensile distensibility, hysteresis and resilient distension with a new method. Comparison with skin thickness as measured with high-frequency ultrasound. J. Dermatol. 198; 12: 318-324.
7) Diffey BL., Oliver RJ., Farr Pm. A portable instrument for quantifying erythema induced by ultraviolet radiation. Br. J. Dermatol. 198; 111: 663-672. 
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