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Some comments on topical flutamide.

From: Bryan
Date: 25 May 2001
Time: 01:30:09
Remote Name: 206.138.228.243

Comments

>>Bryan, did you grab that topical flutamide study I mentioned? Is it worth ordering?<<

I was delayed a bit, but I picked it up tonight and I just finished reading it. You can judge it for yourself, because I've reproduced the entire study below with the exception of the references at the end and a simple graph showing the response of all 18 subjects, their sex, and which drug they received. It's quite short, as studies go.

There are three very interesting things about this study.

The first is that there was only a small difference in effectiveness between pure flutamide and hydroxyflutamide. This is unexpected, since we know now that flutamide itself is a very weak antiandrogen, but once it gets metabolized into hydroxyflutamide, it becomes an extremely potent antiandrogen. I can only think of a couple of ways to explain this result: a) flutamide gets hydroxylated in the skin by local enzymes, just like it does in the liver when taken systemically (there was speculation here a month or two ago that this is what happens); so there would be no significant difference between the topical application of the two drugs, if one gets converted to the other anyway....or b) just like I've been pointing out in the animal experiments for a long time, topical flutamide in humans also works only to the extent that it gets absorbed systemically; in which case, it passes through the liver and gets hydroxylated there as usual, and only then does it have its effect on the sebaceous glands in a systemic fashion. This second explanation could have been easily verified or refuted, of course, by the simple means of measuring the sebum excretion rate at TWO different sites: where the topical flutamide was actually applied, and at a site where it wasn't applied. But unfortunately, the authors didn't design the study this way. Fortunately, though, I AM going to do my own test of flutamide that way! (BTW, I personally lean toward this second explanation.)

The second interesting thing about the study is that there was a difference between the men and the women in their response to the topical drugs. Sebum excretion decreased in men, and *increased* in women! This was very statistically significant (P<0.005).(Well, there was one lone man who also increased in response to hydroxyflutamide! Does that remind you of the Simpson study? :-) But overall, it's troubling to hear about this difference between the sexes. It doesn't seem to admit any obvious explanation. I can't help but wonder if the women were a statistical fluke (the results for the male and female groups weren't individually statistically significant; only the *difference* between the two groups was statistically significant, if I understand the study correctly).

The third interesting thing is the claim they make in the Discussion section: "Furthermore, the [sebaceous gland] response to androgens is dependent on the state of sebaceous activity, and we have found that intradermal androgen decreases sebaceous lipogenesis when basal rates of SER are high and increases it when they are low..." This claim completely took me by surprise. I've never heard such a thing before. I'll definitely check their reference for this. If this is true, not only might it help explain the different results between the sexes, but it might also complicate tests in general of antiandrogens on sebaceous glands.

Here's the full text of the study, minus the references at the end:

British Journal of Dermatology (1982) 107, 697-699. "Sex difference in response of the human sebaceous gland to topical flutamide", Fergus Lyons and Sam Shuster.

Summary: "Sebum excretion rate (SER) was measured before and 4-6 weeks after topical application of flutamide or its hydroxylated metabolite to the forehead skin of eighteen patients with acne. There was a significant difference in response between males and females, SER decreasing by mean of 22% in males and increasing bya mean of 26% in females.

"The non-steroidal anti-androgen flutamide and its hydroxylated metabolite inhibit the hamster flank organ when applied topically (Lutsky et al., 1975; Neri, 1977). Since anti-androgens reduce sebum production in rat and man (Archibald & Shuster, 1969; Shuster & Thody, 1972; Burton, Laschet & Shuster, 1973) and since sebum production is the main determinant of adolescent acne (Cunliffe & Shuster, 1969) we studied the effects of these two compounds on sebum excretion in patients with this condition."

Patients and Methods: "Sebum excretion rate was measured as previously described (Cunliffe & Shuster, 1969) in patients with acne before and 4-6 weeks after a twice daily application of 2% alcoholic gel containing either flutamide (three males and five females) or hydroxylated metabolite (eight males and ten females). All patients continued with their previous medications, none of which included agents known to affect sebaceous gland function. A detailed assessment of classical response was not made and only overall clinical impressions were recorded."

Results: "Since trends were similar for both flutamide and its metabolite the results were combined for analysis (Fig. 1). There was no significant alteration in sebum production with either preparation when the results from males and females were taken together but when results were analyzed separately (Fig. 1) there was a 22% decrease in SER in males and a 26% increase in SER in females with both preparations: this difference is significant (P<0.005). By contrast there was little relationship with initial SER."

Discussion: "although the results show no overall decrease in sebum production in patients with acne treated with the non-steroidal anti- androgen flutamide or its hydroxylated metabolite, there was a significant difference in the response in males and females with a decrease in SER in the former and an increase in the latter. The response of the sebaceous gland to hormones depends both on sex and state of gland activity. Thus whether the sebaceous gland response to progesterone is inhibitory or stimulatory in the rat is sex dependent (Shuster, Hinks & Thody, 1976). In man, likewise, there are sexual differences in androgen metabolism in the skin (Sansone & Reisner, 1971) and in sebaceous gland response to androgens (Strauss, Kligman & Pochi, 1962) and progesterone (Simpson et al., 1979). Furthermore, the response to androgen is dependent on the state of sebaceous activity, and we have found that intradermal androgen decreases sebaceous lipogenesis when basal rates of SER are high and increases it when they are low (Cooper, McGibbon & Shuster, 1979). Although the observations are too few to exclude the contribution of initial rate it seems probable that the dual response we have now found to a topically administered antiandrogen could be explained by sex differences in the control of sebaceous glands by endogenous androgen.

"The overall change in SER was slight and although no attempt was made to assess clinical change there was no overall impression of effect. Further clinical interest is likely to be in analogues rather than the parent compound".

Bryan

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