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Comparing the therapeutic effects of finasteride gel and tablet in treatment of the androgenetic alopecia
Zohreh Hajheydari1, Jafar Akbari2, Majid Saeedi2, Leila Shokoohi1
1 Department of Dermatology, Boo Ali Sina (Avicenna) Hospital, Mazandaran University of Medical Sciences, Sari, Iran
2 Department of Pharmaceutics, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran
Abstract
Background: Finasteride, a type P-selective 5a-reductase inhibitor, as a causative agent of decreasing dihydroxy testestrone (DHT) level, is effective in the treatment of male androgenic alopecia.
Aim: We compared the local and oral finasteride in the treatment of androgenic alopecia.
Method: This is a double blind, randomized clinical trial study of 45 male patients, who were referred with alopecia to the private clinics and departments in Boo-Ali Sina Hospital, in Sari. Patients with male androgenic alopecia were selected according to the history and physical examinations. The patients were randomly divided into two: topical finasteride (A) and oral finasteride (B) groups. Topical finasteride group (A) received a topical gel of 1% finasteride and placebo tablets, while the oral finasteride group (B) received finasteride tablets (1 mg) and gel base (without drug) as placebo for 6 months. The patients were followed by clinical observation and recording of side effects prior to the treatment and at the end of first week, and then by a monthly follow-up. The size of bald area, total hair count, and terminal hair were studied. Data were analyzed by descriptive and Chi-square statistical test.
Results: The mean duration of hair loss was 18.8±23.10 months. Each month the terminal hair, size of bald area and hair count between the two groups were compared. There were no significant differences between the two groups as a viewpoint of hair thickness, hair counts and the size of bald area. Serial measurements indicated a significant increase in hair counts and terminal hair counts between the two groups.
Conclusions: The results of this study showed that the therapeutic effects of both finasteride gel and finasteride tablet were relatively similar to each other.
Methods
This is a double blind clinical trial study. The number of samples (according to previous studies) was 45 young adult men . [3],[9] They were selected among patients referred to private clinics and Dermatology department in the City of Sari, during July 2003 to February of 2005. All of the subjects were having androgenetic alopecia, according to their history and clinical examination. They were placed in the study after they wrote the letter of agreement and satisfaction.
Inclusion criteria were as follows: males under 30 years of age, hair loss duration less than 5 years; maximum hair density 20 hairs/cm²; maximum diameter of the bald area less than 10 cm; and having complete physical and psychological health. Exclusion criteria were patients with male alopecia that were under treated, and patients with baseline disease that causes hair loss.
Method of finasteride gel preparation
Since the water solubility of Finesteride gel is very low, thus, at the beginning of work, solubility had to be increased. For this reason, solvent-aid was used. The solvents-aid is water mixable organic solvents, in which by decreasing solubility, and with surface tension of water, will cause increase water solubility of non-polar materials. An adequate amount of ethanol to increase solubility was determined by several examinations and by setting the drug solubility in different percentages of water-ethanol. After setting and preparing the suitable solvent to solve finasteride, several examinations to select the best polymer were done by different materials. For this reason, first the selected polymer was poured on a glass surface, containing an adequate drug solving system, and was maintained in lab temperature for 24 hours. Then, the receiving system was mixed by an electric mixer by velocity of 600 cycles per minute, until it was completely pure. The results showed that 40% water and 60% ethanol are the best solvent system, and hydroxyl propyl methyl cellulose (HPMC) is the best polymer. Preparation of this drug did not need a preservative. Physical stability of the drug as a viewpoint of deposition or opacity in 4°C in refrigerator was evaluated. Since the time frame between drug production and consumption was about one week, there was no need for chemical assessment. In addition, the placebo gel without drug was prepared by the same system. Because, finasteride 1% has the most dermal absorption, therefore, in this study finasteride gel 1% was prepared and used.
Method
A two-part questionnaire was prepared. The first part was related to the demographic characteristics, and the second part was related to record the information about hair loss (size of bald area, number of terminal hair, and vellus hair).
Results
Of the 45 androgenetic alopecia patients who were enrolled, 7 were excluded from the study due to incomplete or discontinuation of the entire study period. The patient's age range was 22.8±3.3 years. The average time of hair loss in patients, were 23.10 ±18.8 months. Seven (18.4%) were married and 31(81.6%) were single. Among referred patients, 31(81.6%) had a positive family history of male alopecia and in 7(18.4%), it was negative. Nineteen patients entered in group A, while 19 in group B randomly.
The average total hair count, terminal hair count and the size of bald area in both groups in the beginning and end of treatment respectively are shown in [Table 1].
There were no significant statistical differences in the terminal hairs, size of alopecia area and hair count between two groups.
In A group (Finasteride gel and placebo tablet), increased terminal hair count were observed at the third month of treatment ( P =0.001), but increased in terminal hair count was shown in the second months in the B group (Finasteride tablet and placebo gel) ( P =0.015). During therapeutic period, the size of alopecia area was not significantly altered in group A, but in group B, the change in size of alopecia area was significant in the fourth month of treatment ( P =0.027). Increased hair count in two groups were significant in 4 months of treatment ( P =0.001, in group A and P =0.000 in group B). Therapeutic response during therapeutic period in both A and B groups was evaluated by scoring system which shown in [Table 2].
Only one of the patients complained the erythema in affected site as a complication of using local finasteride gel that was subsided immediately after discontinuation of the gel. One of the finasteride tablet user described the decreasing libido.
Επειδή έχει ήδη ανοιχτεί το ίδιο θέμα εδώ, το παρών θα μείνει κλειδωμένο ώστε η συζήτηση σχετικά να παραμείνει σε ένα θέμα.
Zohreh Hajheydari1, Jafar Akbari2, Majid Saeedi2, Leila Shokoohi1
1 Department of Dermatology, Boo Ali Sina (Avicenna) Hospital, Mazandaran University of Medical Sciences, Sari, Iran
2 Department of Pharmaceutics, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran
Abstract
Background: Finasteride, a type P-selective 5a-reductase inhibitor, as a causative agent of decreasing dihydroxy testestrone (DHT) level, is effective in the treatment of male androgenic alopecia.
Aim: We compared the local and oral finasteride in the treatment of androgenic alopecia.
Method: This is a double blind, randomized clinical trial study of 45 male patients, who were referred with alopecia to the private clinics and departments in Boo-Ali Sina Hospital, in Sari. Patients with male androgenic alopecia were selected according to the history and physical examinations. The patients were randomly divided into two: topical finasteride (A) and oral finasteride (B) groups. Topical finasteride group (A) received a topical gel of 1% finasteride and placebo tablets, while the oral finasteride group (B) received finasteride tablets (1 mg) and gel base (without drug) as placebo for 6 months. The patients were followed by clinical observation and recording of side effects prior to the treatment and at the end of first week, and then by a monthly follow-up. The size of bald area, total hair count, and terminal hair were studied. Data were analyzed by descriptive and Chi-square statistical test.
Results: The mean duration of hair loss was 18.8±23.10 months. Each month the terminal hair, size of bald area and hair count between the two groups were compared. There were no significant differences between the two groups as a viewpoint of hair thickness, hair counts and the size of bald area. Serial measurements indicated a significant increase in hair counts and terminal hair counts between the two groups.
Conclusions: The results of this study showed that the therapeutic effects of both finasteride gel and finasteride tablet were relatively similar to each other.
Methods
This is a double blind clinical trial study. The number of samples (according to previous studies) was 45 young adult men . [3],[9] They were selected among patients referred to private clinics and Dermatology department in the City of Sari, during July 2003 to February of 2005. All of the subjects were having androgenetic alopecia, according to their history and clinical examination. They were placed in the study after they wrote the letter of agreement and satisfaction.
Inclusion criteria were as follows: males under 30 years of age, hair loss duration less than 5 years; maximum hair density 20 hairs/cm²; maximum diameter of the bald area less than 10 cm; and having complete physical and psychological health. Exclusion criteria were patients with male alopecia that were under treated, and patients with baseline disease that causes hair loss.
Method of finasteride gel preparation
Since the water solubility of Finesteride gel is very low, thus, at the beginning of work, solubility had to be increased. For this reason, solvent-aid was used. The solvents-aid is water mixable organic solvents, in which by decreasing solubility, and with surface tension of water, will cause increase water solubility of non-polar materials. An adequate amount of ethanol to increase solubility was determined by several examinations and by setting the drug solubility in different percentages of water-ethanol. After setting and preparing the suitable solvent to solve finasteride, several examinations to select the best polymer were done by different materials. For this reason, first the selected polymer was poured on a glass surface, containing an adequate drug solving system, and was maintained in lab temperature for 24 hours. Then, the receiving system was mixed by an electric mixer by velocity of 600 cycles per minute, until it was completely pure. The results showed that 40% water and 60% ethanol are the best solvent system, and hydroxyl propyl methyl cellulose (HPMC) is the best polymer. Preparation of this drug did not need a preservative. Physical stability of the drug as a viewpoint of deposition or opacity in 4°C in refrigerator was evaluated. Since the time frame between drug production and consumption was about one week, there was no need for chemical assessment. In addition, the placebo gel without drug was prepared by the same system. Because, finasteride 1% has the most dermal absorption, therefore, in this study finasteride gel 1% was prepared and used.
Method
A two-part questionnaire was prepared. The first part was related to the demographic characteristics, and the second part was related to record the information about hair loss (size of bald area, number of terminal hair, and vellus hair).
Results
Of the 45 androgenetic alopecia patients who were enrolled, 7 were excluded from the study due to incomplete or discontinuation of the entire study period. The patient's age range was 22.8±3.3 years. The average time of hair loss in patients, were 23.10 ±18.8 months. Seven (18.4%) were married and 31(81.6%) were single. Among referred patients, 31(81.6%) had a positive family history of male alopecia and in 7(18.4%), it was negative. Nineteen patients entered in group A, while 19 in group B randomly.
The average total hair count, terminal hair count and the size of bald area in both groups in the beginning and end of treatment respectively are shown in [Table 1].
There were no significant statistical differences in the terminal hairs, size of alopecia area and hair count between two groups.
In A group (Finasteride gel and placebo tablet), increased terminal hair count were observed at the third month of treatment ( P =0.001), but increased in terminal hair count was shown in the second months in the B group (Finasteride tablet and placebo gel) ( P =0.015). During therapeutic period, the size of alopecia area was not significantly altered in group A, but in group B, the change in size of alopecia area was significant in the fourth month of treatment ( P =0.027). Increased hair count in two groups were significant in 4 months of treatment ( P =0.001, in group A and P =0.000 in group B). Therapeutic response during therapeutic period in both A and B groups was evaluated by scoring system which shown in [Table 2].
Only one of the patients complained the erythema in affected site as a complication of using local finasteride gel that was subsided immediately after discontinuation of the gel. One of the finasteride tablet user described the decreasing libido.
Επειδή έχει ήδη ανοιχτεί το ίδιο θέμα εδώ, το παρών θα μείνει κλειδωμένο ώστε η συζήτηση σχετικά να παραμείνει σε ένα θέμα.