double blind clinical study
Double blind clinical study

14 November, 2000


A REPORT ON THE USE OF ARCON BIOSPRAY AND ARCON TISANE

The Researcher Annikki Hagros-Koski, Bachelor of Science
Hair Academy 
Yrjönkatu 23

00100 HELSINKI

Finland

Tel. +358-(0)9-6122 700

Fax. +358-(0)9-6122 7050

E-mail: salon.alexandra@co.inet.fi

The Research Assistant

Pauli Koski and Pia Reinikka, assisting in the video taping

Annika Hagros, Master of Science, assisting in the diagrams

The Orderer of the Research Arcon World Wide

The Consultants and Overseers of the Research 


Risto Oksman, Dermatologist 
Riitta Meri,Gynecologist




The Writer of the Report
Pirkko Hatara,Teacher of Hairdressing, M.Sc.


The Monitoring System of the Overseers


The criteria and the testing methods were planned together with doctors Riitta Meri and Risto Oksman. 



Pirkko Hatara has been a supervisor in the analysis phase of the test persons in the finishing situation of the test. She has accepted the comparison results of the photos and videos which have been taken in the beginning and in the end of the test. 




Testing Products Arcon-Tisane (capsule), active ingrediens: Fenugreen
Arcon-Biospray (mouth spray), active ingrediens: the exract of serenoa repens


The Type of the Research 

A Double Blind Research 





The Research Problem 
The aim of the research was to find out what kind of possibilities Arcon products can have to reduce hair loss and to regrow lost hair to persons who have had a male type hair loss. In addition another purpose of the test was to find out what kind of side effects Arcon products may cause to persons who use them. 





The Testing Period 

The test group started to use the test products after March 17th 2000. The products were estimated to last for six months.





The Sample of the Research


The first plan was to recruit as test persons 20 women and 80 men who have the male type hair loss. It proved difficult to find women who had the male type hair loss and who would be interested in starting the use of Arcon products. Two women who promised to start testing the products cancelled their participation in the test. One of them was frightened because there was a text “for men only” written on the bottle. The other woman had been in an allergy test where it was found that many herbs can cause allergic reactions to her and therefore she did not want to try Arcon products which include some herbs, too.

It was agreed with the orderer of the research that men will be taken instead of women so that the total number of the test group was 100 persons, 13 women and 87 men. The age distribution of these people was from 20 to 70 years old (Appendix 1). 

During the test one woman and one man interrupted their participation. The woman did not inform at all on her cancellation and no final photos have not been taken of her. The man finished after three months and there are final photos of him.


One man changed his hairstyle so much that it was impossible to estimate any results from the photo comparison.



In total there were 97 test persons in the final photo and video comparison.



The Selection of the Sample


The test was advertised in Helsingin Sanomat in February 2000. The people who were interested in participating in the test were asked to contact at Hair Academy. About 1000 people phoned and nearly 400 people were invited to Hair Academy. After the interviews and the analyses of the hair and scalp 100 test persons were selected.


In the analysis of hair and scalp it was confirmed that all test persons had the male type hair loss. The way of the analysis was to take off about 10 - 15 hairs from every person and examine the roots of them by microscope. Also scalps were examined visually if there were any problems in the skin.



It proved difficult to find scalps healthy enough. There were 16 persons who had a healthy scalp and 36 test persons who had light inflammation in their scalp. In addition 26 test persons’ scalp was a little irritated and 5 persons had some redness in the scalp.





The Informed Consent 
Before the test started every test person got information about the products and their uses.


(Usage: One capsule of Arcon-Tisane a day and Arcon Biospray twice daily [one pressing of spray in the mornings and the evenings].)


They were told that half of the products were real and half are placebos. They were informed that after the test period also the persons who have used the placebos would get same amount of the real products. The test persons signed the agreement 1) to use the test products according to the instructions, 2) to come after six months to the final analysis and 3) to give all information which would be relevant to the test.





The Assessment of the Initial Phase 


The photographs and the videos were taken. The bald areas of the test persons were measured. They were given written instructions how to use the test products. Every test person was informed that healthy skin is a basic requirement for the good hair growth. 




The Distribution of the Testing Products 


The test products were marked as number 2 or 3. They were dealt out randomly to the test group by Salon Alexandra reception personnel. 




The Assessment of the Final Phase



The photographs and the videos were taken. The persons’ own opinions of the changes of their hair amount and the possible side effects were asked. The researchers’ opinions were written down according to the comparison of the initial photo with the persons’ hair themselves. 



The differences of the initial situations and the final situations of the hair amount were easiest to find out by comparing the photos of the initial phase and the photos of the final phase. The video tapes proved more difficult to use as the comparing material but in some cases videos can confirm the photograph comparison.





The Assessment Problems of the Results


It was not possible to find 100 persons with the male type hair loss who had not any problems with their scalp at all. And so the test group included persons who had light inflammation in their scalp. It was difficult to estimate how much inflammations influenced the hair loss.



The persons had used different amounts of Arcon Biospray because some of them had difficulties in measuring out the mouth spray. Some of them had used up all the Arcon Spray a few days earlier and some of them had still some left after the six months period. One of the test persons used his Arcon spray for less than three months. Arcon-Tisane capsules had been used properly. On the average the test persons had very carefully followed the instructions how to use the products.



The final measuring of the bald areas of the persons proved inexact because of technical reasons. Usually there had not been so clear dividing line around the bald and hairy area, and therefore it was impossible to determine the measuring point.



The photo comparison was more difficult to make if the length of the hair, greasiness, colour or curliness were changed. If the hair was cut nearly bald it was also very difficult to notice whether more hair had grown. After summer the scalps were more tanned and the hair was lighter. The comparison was also more difficult if there was no clearly bald area in the scalp. In Appendix 13 the testers’ comments of the photo comparison of the initial photos and the final photos are shown.





The Results
The test persons who had used product 2 got more hair: 9 persons had got a little stronger hair but the rest of them had got moderate additional hair growth, two persons had got clearly more hair. 



The test persons who had used product 3 had mostly (23 persons) the same situation with the hair amount as in the initial situation. In addition three of them had decreased hair amount. 14 persons that used product 3 had got a little more hair and 6 persons had got quite moderate more new hair. There was also one person who used product 3 who had clearly more hair. (Appendix 2).



The men who used product 3 had stayed more commonly in the same situation with their hair amount than the women who used product 3. The women in this group had got more commonly new hair. Both men and women who used product 2 had got more hair. The group of women (13 persons) was so small that the comparison situation between men (84 persons) and women was not equal. (Appendices 3-4).



No great differences in the growth of hair was seen between the age group 20 – 35, 36 - 50 and 51 – 70 years old. Persons in the youngest group had got a little more (it has marked number 1) additional hair growth than the age group 36 – 50 and 51 – 70 but the older groups had got more common moderate more (it has marked numbers 1,5, 2 and 2,5) new hair than the youngest test persons. (Appendices 5-7).



The duration of the hair loss varied in the test group from 2 years to 40 years. If we compare the duration of hair loss to the addition of the hair between groups 2 – 6 years, 7 – 15 years and 16 – 40 years we find that the persons who had had hair loss for 7 – 15 years and used the product 2 had had the best improvement in the hair growth. A few test persons from the group which had had hair loss 16 – 40 and used the product 2 had very good results in the hair addition. If hair loss had lasted 2 – 6 years (product 2) there was slightly less new hair than in the other age groups. Actually there were no great differences between these three groups. When we compare these three groups we have noticed that the group which have had the hair loss for 7 – 15 years was the largest one. (Appendices 8-10).



If we compare the test persons’ own opinions and the testers’ opinions how the situation of the hair amounts had changed during the test period to the results of the photo comparison we can notice very large differences. In many cases the test persons themselves said that there have not happened any changes in the amount of their hair after the initial situation, but the photo comparison had indicated that there had been moderate improvements in the hair amount. The overall majority of the test persons who used product 2 thought that they had got a little more hair during the test period. Meanwhile the test persons who used product 3 mostly commented that the situation of their hair amount had not changed at all. On the average the testers had often been a little more optimistic about the hair additions than what the photo comparison indicated but in many cases the testers had also estimated the hair amount to be less than the photo comparison. (Appendices 11-12).



The test persons did not have many side effects. 8 test persons (5 using product 2, 3 using product 3) had noted that they had had some side effect symptoms during the test period. The users of product 2 had had two positive and three negative side effects. The users of product 3 had had one positive and two negative side effect symptoms. (Appendix 14).





Conclusions 
The research pointed out that


1. the product 2 seems to influence increasingly on hair amount with the men and women who had male type hair loss. The product 2 also seems to give more thickness of the body to a hair because all the test persons used product 2 hair felt stronger.
16,3 % of the test persons using product 2 had got a slight increase (Table 1), 
65,1 % of them had got a moderate increase, and 
18,6 % of them had got a clear increase in hair. 
(Appendices 2-4).


In the tables below both the men’s and women’s hair growth is compared but it should be noticed that the group of the women is much smaller than the group of the men.





Table 1: The increased amount of hair of the men 



The Hair Addition
No increase
A slight increase
A moderate increase
A clear increase

Product 2

(43 persons)
0 %
16,3 %
65,1 %
18,6 %

Product 3

(41 persons)
58,6 %
26,8%
12,2 %
2,4 %






Table 2: The increased amount of hair of the women 



The Hair Addition
No increase
A slight increase
A clear increase
A very clear increase

Product 2

(5 persons)
0 %
40 %
40 %
20 %

Product 3

(8 persons)
37,5 %
50 %
12,5 %
0 %


No increase: The values –1 and 0 of the photo comparison

A slight increase: The value 0,5 of the photo comparison

A moderate increase: The values 1 and 1,5 of the photo comparison

A clear increase: The values 2 and 2,5 of the photo comparison






If we count together the columns “a moderate increase“ and “a clear increase” (product 2) it seems that men had got more commonly a remarkable amount of additional hair. Meanwhile the women had got more commonly new hair by using product 3 than men. A conclusion may be that women take a better care of their hair, physical condition and diet than men, when they commit to a test with new products. 
Usually people become more interested in taking care of their hair and scalp if some professional person gives them instructions how to do it. Therefore there had appeared a little more growth of hair also with the persons who had used product 3. (Appendices 2-4).





2. the age of test persons does not seem to influence much on how efficiently the Arcon products regroe new hair to people who have had the male type hair loss. In the table below it is compared the addition of hair amount of different age groups.





Table 3: The effect of the age, age group 20 – 35 years



The Hair Addition
No increase
A slight increase
A moderate increase
A clear increase

Product 2

(18 persons)
0 %
11,9 %
70,7 %
17,6 %

Product 3

(14 persons)
54,5 %
21,5 %
7,1 %
7,1 %












Table 4: The effect of the age, age group 36 - 50 years 



The Hair Addition
No increase
A slight increase
A moderate increase
A clear 

increase

Product 2

(15 persons)
0 %
13,5 %
66,7 %
20 %

Product 3

(22 persons)
43,5 %
39,1 %
17,4 %
0%






Table 5: The effect of the age, age group 51 - 70 years 



The Hair Addition
No increase
A slight increase
A moderate increase
A clear increase

Product 2

(16 persons)
0 %
26,7 %
53,3 %
20 %

Product 3

(12 persons)
58,3 %
33,4 %
8,3 %
0%


No increase: The values –1 and 0 of the photo comparison

A slight increase: The value 0,5 of the photo comparison

A moderate increase: The values 1 and 1,5 of the photo comparison

A clear increase: The values 2 and 2,5 of the photo comparison





If we count together a moderate and a clear increased hair growth of the age group 20 – 30 years (product 2) we can see that 88,3 % of them had got remarkably more hair. 86,7 % of the age group 36 – 50 and 73,3 % of the age group 51 – 70 had a moderate or a clear increase in the amount of hair.



There were also some good results of hair growth among the oldest age group. (Appendices 5-7).





3. The duration of hair loss does not influence greatly on how efficiently the Arcon products regrow new hair on people who have had the male type hair loss. In the table below it is compared the addition of hair amount of tests persons whom hair lost have lasted different time period.





Table 6: The effect of the duration of hair loss, 2 - 6 years 

(26 persons)

The Hair Addition
No increase
A slight increase
A moderate increase
A clear increase

Product 2

(14 persons)
0 %
15,4 %
61,6 %
23,1%

Product 3

(12 persons)
33,3%
33,3 %
58,3 %
8,3 %






Table 7: The effect of the duration of hair loss, 7 - 15 years 

(40 persons) 

The Hair Addition
No increase
A slight increase
A moderate increase
A clear increase

Product 2

(18 persons)
0 %
16,7 %
72,2 %
11,1 %

Product 3

(22 persons)
63,6 %
22,7 %
13,6 %
0%






Table 8: The effect of the duration of hair loss, 16-40 years 

(19 persons)

The Hair Addition
No increase
A slight increase
A moderate increase
A clear increase

Product 2

(10 persons)
0 %
20 %
60 %
20 %

Product 3

(9 persons)
66,7 %
22,7 %
22,2 %
0%


No increase: The values –1 and 0 of the photo comparison

A slight increase: The value 0,5 of the photo comparison

A moderate increase: The values 1 and 1,5 of the photo comparison

A clear increase: The values 2 and 2,5 of the photo comparison



If we count together the columns (product 2) “A moderate” and “A clear increase” of hair amount we can see that there are in the group of the duration of hair loss 2 – 6 years 84,7 % remarkable more hair, the duration of hair loss 7 – 15 years 83,3 % and the duration of hair loss 16 – 40 years 80 %. These numbers point out that it is not essentially depending on of the duration the hair loss how much the product 2 can reproduce new hair.

(Appendices 8-10).





4. People can not easily notice visually the change of the hair amount if there is no objective evidence like photographs which are pointed out with diagrams on appendices 11-12.





5. The Arcon products do not cause remarkable side effects. Only very few people during the test had any side effects. If we present them in percentage it caused positive side effects to 2 % of the test persons using product 2 and negative effects to 6,3 % the test persons using product 2. The product 3 caused negative side effects to 4 % and positive ones to 2 % of the test persons. (Appendix 14).





In Helsinki 15. November 2000


Annikki Hagros-Koski

The Researcher



In Helsinki 15. November 2000


Pirkko Hatara, Teacher of Hairdressing, The Writer of the Research 





The letter form Arcon UK Ltd. included information which products were authentic received and opened 8th of November 2000 in Hair Academy. (Appendix 15).



The authentic products were marked number 2.

The placebos were marked number 3. 







I want to thank following assisting persons for the great help selecting test persons

Christina Godenhjelm, Hair Analyst, Hair Academy

Kaisa Hämälainen, Hairdressing Student of Helsinki Polytechnique



Annikki Hagros-Koski