Originally posted by: Celco
Im going to drive my self down to the university library today and dig out full version of these studies on pge2.
I will report soon.
Ok, I did some hairloss work today. I dug out those two PGE2 studies and had a look at them.
The first study was in "New Topical Agents for Hair Growth" by Henry Roenigk in Clinics in Dermatology Journal from 1988.
This article discusses three types of topicals for potential use in treating male pattern hairloss. The three topicals were Diazoxide, Viprostol (PGE2 analog) and Cyclosporine.
The article is not very clear but I think it refers to two studies that were done on Viprostol. One seems to be an inhouse study done by a company called American Cyanamid in 1985 - "A double blind, placebo controlled study assessing the efficacy of CL 115-347 in promoting hair growth when administered for 24 weeks to the scalp of male subjects with male pattern baldness. CL 115-347, Clinical Study Protocol: l-28, 1985 (data on file)." The second study seems to have been done by the author.
Anyway this is what it says:
Viprostol is a synthetic prostaglandin E analogue would seem to be to be an effective vasodilater and antihypertensive drug (unpublished data).* Its mode of action as an antihypertensive appears to be the reduction of peripheral resistance through its relaxing actions on smooth muscle. Early studies suggested that direct application of viprostol to the bald scalp promotes hair growth and the transformation of vellus to terminal hair by increasing nutritive blood flow to the scalp.
Equivocal evidence of mild liver dysfunction was noted in a preliminary study in healthy subjects after they received repeated doses of 120 pg of viprostol to the bald scalp. A rechallenge study, however, showed no effect on serum transaminase levels, indicating no clinically significant trend or safety concerns with regard to liver dysfunction.* No other side effects were reported.
A l-year, double-blind, placebo-controlled study was conducted to determine the effectiveness of viprostol in patients with male-pattern baldness. The study was conducted at 10 centers including Northwestern University Medical School. Each center enrolled 20 patients. Seventeen of our patients completed 6 months and 13 completed the l-year treatment period. At the end of the l-year study, ten patients had increased hair growth from baseline and five of these patients doubled their terminal hair count; three patients had no noticeable hair growth (Table 17-1). All of our viprostol-treated patients had increased hair growth at 24 weeks, and six of the 10 doubled their hair count by 50 weeks. Three of the seven placebo-treated patients had increased hair growth. Curiously, when data were collected from all of the centers, hair-growing activity could not be substantiated and the studies were discontinued."
So the ten patients that they show in the article who were treated with topical viprostol all had some good hair growth.
Baseline mean for all 10 was 62.1 terminal hairs. After 50 weeks of topical viprostol treatment terminal hair mean was 153.1 (more than double). The best responder went from 18 terminal hairs at baseline to 196 after 50 weeks! That's pretty good.
However this wasn't replicated in the other groups and the study was discontinued. The article does not give much further details.
The second article I looked at was "Transdermal viprostol in the treatment of male
pattern baldness" in the Journal of the American Academy of Dermatology. This was a more formal and better reported study done by Olsen and DeLong in 1990.
Seventy-two men(age range 18 to 50 years)witheither pattern Illv, IV, or V male pattern baldness (Hamilton-Norwood classification'P II) entered the study. Only healthy subjects as determined by a history, physical examination, electrocardiography, chest x-radiation, and laboratory evaluation (CBC, serum chemistry profiles, urinalysis) were eligible. No subject had used topical minoxidil or any topical hormonal preparation previously for androgenetic alopecia and none had hair transplants. No subject was taking any medication associated with hair growth, any antihypertensive agents, or other vasodilators."
Subjects were randomly assigned, in a double-blind fashion, to receive either activedrug, vehicle, or placebo. The silicone-based vehicle was a combination of polydimethylsiloxane,
C12-15 alcohols, benzoate, and cyclomethicone. The placebo was a water-soluble mixture of inert agents."
Baseline demographic characteristics of each treatment group are shown in Table 1.A significant decline was noted in nonvellus target area hair counts in 6 months according to both observers. The decrease was most pronounced in the group treated with vehicle but there were no significant differences between treatment groups PGE2(Table II). Patient and investigative assessments of hair growth are given in Tables III and IV, respectively; there were no significant differences between treatment groups."
So the results did not show hair growth with topical PGE2 analog however there are a few things I picked up on in the study.
Firstly in the Ohlsen study the men tested where predominantly NW 5 and the average length of time of balding was about 13 years. Regrowth of follicles after they have been minaturising for that long is very unlikely.The lowest category of hairloss they would accept in the study was NW 3V. There were only 9 NW 3Vs, 13 NW 4 and 35 NW 5s!
The other issue I have with the study is that the group that lost the most hair after 6 months where those that were using the VEHICLE ONLY.
In other words looking at the study results the vehicle was actually CAUSING hairloss because those using the vehicle had about 2.5 times more hairloss than the placebo group
. Maybe the vehicle was creating further inflammation and causing hairloss, I don't know???
The loss in the group using Vehicle + Viprostol was about the same as with placebo although slightly more. So to my untrained eye it looks like the Viprostol PREVENTED some hairloss which was being caused by the vehicle. I'm suprised the authors didn't address this issue of the VEHICLE causing hairloss
. It was very glaring that the VEHICLE on it's own was causing a whole lot of hairloss - about 2.5 times worse than the placebo!
So despite the Ohlsen study I still think that topical PGE2 is a good addition to a hairloss regimen as long as it is combined with PGD2 blocking. None of the studies tested PGE2 in the context of reduced PGD2.
The other take home message from the study is that the vehicle needs to be right. What the Ohlsen study showed to me WASN'T that PGE2 analog doesn't work but that the vehicle used to administer it can cause serious acceleration of hairloss. I'd like to see PGE2 tested again but this time in a vehicle that isn't clearly shown to make you go BALD faster!
1.25mg Fin daily
Minox foam or liquid intermittently
Nizoral shampoo every 2-3 days
We need something better than Fin approved that targets the scalp only.
We need much better hair growth stimulants.
03:02 AM by