chore boy
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Found this earlier today... patent appears to have been filed mid-last year.
1. Experimental Procedure
A. Preparation of the Composition
[0043] In one embodiment, an active composition was prepared by adding 100 mg of estradiol, 100 ?g of triiodothyronine and 100 mg of liquid progesterone to 15 ounces of a commercially available baby shampoo. Representative baby shampoos may include, but are not limited to, those sold under the brand names JOHNSON'S®, GERBER® and HUGGIES®. A placebo composition was further provided which included the shampoo without the hormonal component.
B. Study Participants
[0044] Both men and women were selected to participate in the experimental trials. In particular, 45 men and women, ages 22 years to 78 years, including established patients (RHC) and other persons were selected and placed into experimental groups. Ten women were assigned to a placebo group (Group A) and nine women were assigned to an active group (Group B). This was done by random assortment (NOS 1-19). An additional active group of 26 people, 17 men and nine women, were selected to take part in an open label trial to help expand the database (Group C). Persons with a history of breast cancer or open scalp lesions were
excluded from the trial. Those conducting the experiment were blinded as to which shampoo included the hormonal component. Only a pharmacist who formulated the shampoo was aware of which formulations were placebos and which were active.
C. Procedure
[0045] Each participant was given a IS ounce bottle of baby shampoo in which hormones were or were not added to it. A variety of shampoo brands were used. Each participant was further given a one ounce plastic cup and asked to use a half ounce of shampoo daily. The shampoo was rubbed into the hair and scalp and then allowed to interact with the scalp for ten minutes. Participants were then instructed to rinse off the shampoo. Participants were allowed to use conditioner if desired. Each participant was scheduled to return every 30 days for a total of 180 days (e.g., 7 visits: 0, 30, 60, 90, 120, 150, 180 days). At each visit a picture of the scalp was taken. Blood was further drawn at each visit to test for levels of thyroid stimulating hormone (TSH), total thyroxine (T4), estradiol, progesterone, sex hormone binding globulin (SHBG) and, in men, serum testosterone levels. All assays were run on the IMMULITE® 2000 (Diagnostics Product Corporation, Los angeles, CA) using DPC test kits. Laboratory technologists did not know which participants were using active or placebo shampoos.
D. Results
[0046] Extensive lab data as illustrated in the figures and tables as follows showed no significant absorption of the added hormones in all groups at the different time periods both within and between groups. AU data is given by actual numbers (Tables 1-7) or by comparison of average plus standard error measurement (SEM) (Figures 1-7). It should be noted that the range for hormone levels was at the low end and all changes in levels appear greater than they are due to the scale of the graphs.
[0047] Results of each group were assessed for absorption of the hormone and efficacy of the composition in treating androgenic alopecia. Absorption was determined by analyzing total T4, TSH and total testosterone levels as well as levels
of estradiol, progesterone and sex hormone binding globulin and triiodothyronine resin uptake (T3RU) found in the blood of the study participants. Were significant absorption to occur, total T4, TSH and total testosterone levels would be expected to decrease, an increase in estradiol and progesterone levels would be expected and SHBG and T3RU would be expected to remain level. Absorption of T3 would be expected to cause reciprocal suppression of TSH which would have led to decreased total T4 levels. Efficacy was assessed by visual inspection of each participant's scalp and hair volume at each visit.
[0048] Results from visual inspection of each patient showed no hair growth in patients in Group A, the placebo group. Results from the remaining groups showed a distinct increase in hair from day 0 to days ISO- 180. In particular, in Group A, zero to 10 percent of the bald areas were covered at the end of the 180 day period. In Groups B and C, 65% to 98% of the bald areas were covered.
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1. Experimental Procedure
A. Preparation of the Composition
[0043] In one embodiment, an active composition was prepared by adding 100 mg of estradiol, 100 ?g of triiodothyronine and 100 mg of liquid progesterone to 15 ounces of a commercially available baby shampoo. Representative baby shampoos may include, but are not limited to, those sold under the brand names JOHNSON'S®, GERBER® and HUGGIES®. A placebo composition was further provided which included the shampoo without the hormonal component.
B. Study Participants
[0044] Both men and women were selected to participate in the experimental trials. In particular, 45 men and women, ages 22 years to 78 years, including established patients (RHC) and other persons were selected and placed into experimental groups. Ten women were assigned to a placebo group (Group A) and nine women were assigned to an active group (Group B). This was done by random assortment (NOS 1-19). An additional active group of 26 people, 17 men and nine women, were selected to take part in an open label trial to help expand the database (Group C). Persons with a history of breast cancer or open scalp lesions were
excluded from the trial. Those conducting the experiment were blinded as to which shampoo included the hormonal component. Only a pharmacist who formulated the shampoo was aware of which formulations were placebos and which were active.
C. Procedure
[0045] Each participant was given a IS ounce bottle of baby shampoo in which hormones were or were not added to it. A variety of shampoo brands were used. Each participant was further given a one ounce plastic cup and asked to use a half ounce of shampoo daily. The shampoo was rubbed into the hair and scalp and then allowed to interact with the scalp for ten minutes. Participants were then instructed to rinse off the shampoo. Participants were allowed to use conditioner if desired. Each participant was scheduled to return every 30 days for a total of 180 days (e.g., 7 visits: 0, 30, 60, 90, 120, 150, 180 days). At each visit a picture of the scalp was taken. Blood was further drawn at each visit to test for levels of thyroid stimulating hormone (TSH), total thyroxine (T4), estradiol, progesterone, sex hormone binding globulin (SHBG) and, in men, serum testosterone levels. All assays were run on the IMMULITE® 2000 (Diagnostics Product Corporation, Los angeles, CA) using DPC test kits. Laboratory technologists did not know which participants were using active or placebo shampoos.
D. Results
[0046] Extensive lab data as illustrated in the figures and tables as follows showed no significant absorption of the added hormones in all groups at the different time periods both within and between groups. AU data is given by actual numbers (Tables 1-7) or by comparison of average plus standard error measurement (SEM) (Figures 1-7). It should be noted that the range for hormone levels was at the low end and all changes in levels appear greater than they are due to the scale of the graphs.
[0047] Results of each group were assessed for absorption of the hormone and efficacy of the composition in treating androgenic alopecia. Absorption was determined by analyzing total T4, TSH and total testosterone levels as well as levels
of estradiol, progesterone and sex hormone binding globulin and triiodothyronine resin uptake (T3RU) found in the blood of the study participants. Were significant absorption to occur, total T4, TSH and total testosterone levels would be expected to decrease, an increase in estradiol and progesterone levels would be expected and SHBG and T3RU would be expected to remain level. Absorption of T3 would be expected to cause reciprocal suppression of TSH which would have led to decreased total T4 levels. Efficacy was assessed by visual inspection of each participant's scalp and hair volume at each visit.
[0048] Results from visual inspection of each patient showed no hair growth in patients in Group A, the placebo group. Results from the remaining groups showed a distinct increase in hair from day 0 to days ISO- 180. In particular, in Group A, zero to 10 percent of the bald areas were covered at the end of the 180 day period. In Groups B and C, 65% to 98% of the bald areas were covered.
http://www.wipo.int/pctdb/en/wo.jsp?wo= ... SPLAY=DESC