Androgenetic alopecia treated with topical minoxidil

Androgenetic alopecia treated with topical minoxidil

Topical minoxidil in androgenetic alopecia Androgenetic alopecia treated with topical minoxidil Richard L. De Villez, M.D. San Antonio, TX A randomize...

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Topical minoxidil in androgenetic alopecia Androgenetic alopecia treated with topical minoxidil Richard L. De Villez, M.D. San Antonio, TX A randomized double-blind trial of topical minoxidil "'"as carried out during a 12-month period in 56 patients with male pattern baldness. Subjects were randomly assigned to treatment with either 2% minoxidil solution, 3% minoxidil solution, or placebo. The placebo group was switched to 3% minoxidil after the first 4 months. Subjects llsing the 2% and 3% solutions of minoxidil showed a significant change in terminal and indeterminate hair counts (p < 0.05) from the placebo group at 4 months. A progressive decrease in vellus hair counts with a concomitant increase in both indeterminate and terminal hair counts was noted during the l2-month period, suggesting that minoxidil applied topically partially reverses the balding phenomenon. (J AM ACAD DERMATOL 1987;16:669-72.)

The use of topical minoxidil in androgenetic male pattern alopecia has been reported. I •2 In a randomized double-blind trial of topical minoxidil solution in 56 patients with male pattern baldness, cosmetically acceptable hair growth was achieved in 18 (32%).1 METHODS AND PATIENTS Patient selection Fifty-six of 64 male patients with androgenetic alopecia completed a 12-month randomized double-blind treatment with topical minoxidil solution at the University of Texas Health Science Center at San Antonio. Subjects were required to have a discernible balding patch a minimum of 1 inch in diameter on the vertex or crown of the head suitable for observation of hair growth. Only subjects with dark hair were selected because of the difficulty in counting and photographing blond hairs. Patients with hair loss ranging from Hamilton patterns of type III vertex through type VI were entered into the study.3 Those with more extensive al-

From the Division of Dermatology, University of Texas Health Science Center. Reprint requests to: Dr. Richard L. De Villez, Associate Professor, Division of Dermatology, University of Texas Health Science Center at San Antonio, 7703 Floyd Curl Dr., San Antonio, TX

78284-7876.

opecia were not included. Informed consent was obtained from all study subjects. Laboratory examinations were performed before treatment and again at 4 and 12 months of treatment as noted previously. I Minoxidil was supplied by The Upjohn Company in 60 cc bottles with a dropper marked at 1.0 cc. The 12 bottles for each patient were dispensed in numeric order. The placebo group received the solution containing only the vehicle for the first 4 months and then were switched over to the 3% solution of minoxidil for the remainder of the study. The balance of the study patients were randomized to receive a 2% or 3% solution of minoxidil in a double-blind manner for the entire study period. Study medication was applied as noted previously.1

Hair counts Before treatment and at monthly intervals thereafter, a circle 1 inch in diameter was drawn over the balding spot of the vertex with a skin marker and a template. The center of the circle was located by a three-point measurement, using the midpoint between the ears and a fixed distance from the base of the nose. These measurements were recorded at each visit. With the aid of an eight-power magnifying lens mounted on a circular fluorescent desk lamp, the hairs in the I-inch diameter circle were counted and categorized as vellus hairs, indeterminate hairs, or terminal hairs. Nonpigmented

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short hairs were defined as vellus; pigmented hairs ranging from thin and short to slightly longer and thicker were defined as indeterminate. Hairs of the same color and bore diameter as those in adjacent nonbalding areas were classified as terminal. The count was repeated three times and the average used as the final count.

Statistical analysis Variables were analyzed at selected time points by a standard X2 test. Group comparisons were made by ordinary group t-test.

RESULTS

Of the 64 patients originally enrolled in the study, 22 used the 2% minoxidil solution, 20 used the 3% solution, and 22 used placebo for 4 months before switching to the 3% solution. Eight patients dropped out early and 56 subjects remained in the study, applying the topical solution twice daily for 12 months. Subjects using the 2% and 3% solutions of minoxidil demonstrated a significant change in terminal hair counts (p < 0.05) as compared with the

placebo group at 4 months (Fig. 1). Throughout the study there was no significant difference in terminal hair counts between the groups using the 2% and 3% solutions. An increase in terminal hairs occurred among the placebo group 3 months after switching to the 3 % solution of minoxidil. The clinical observation of demonstrable hair growth in all treatment groups was made at 8 months, correlating with the increase from baseline of 25 to 30 new terminal hairs in the area of evaluation. Indeterminate hair counts for those subjects using the 2% or 3% minoxidil solutions were significantly different from the placebo group (p :< 0.05) at the fourth month (Fig. 2). There was no significant difference between the patients using the 2% or 3% solutions during the study period. The indeterminate hair counts began to plateau 8 months into the study. Vellus hair counts from patients using the 3% solution of minoxidil began to decrease at the second month, whereas those for patients using the 2% solution began to decrease at the fourth month

Volume 16 Number 3, Part 2 March 1987

Androgenetic alopecia treated with topical minoxidil 671

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months. Treatment groups using 2% and 3% minoxidil are significantly different at 4 months from the placebo group (p < 0.05). (Fig. 3). There was a significant increase in vellus hair counts in the placebo group (p < 0.05) as compared with the treated groups at the fourth month. At the end of the study there was no significant difference between patients using the 2% or 3% concentrations.

DISCUSSION Androgenetic alopecia in men is an expression of the androgen factor on the genetic factor in nonandrogen-dependent hair. This process causes a metamorphosis of the terminal hair to vellus hair over successively shortened hair-growth cycles. By means of an unknown mechanism, minoxidil applied topically to the balding area partially reverses that trend. The present study demonstrated a decrease in vellus hairs with concomitant increase in indeterminate and terminal hairs during the 12-month study period. There was an initial increase in vellus hairs at

1 month in all groups, with a significant rise in the placebo group (Fig. 3). The increase in the placebo group may represent stimulation by the ingredients in the placebo or more efficient counting on the part of the examiner. The subsequent drop in vellus hair counts correlates with the rise in indeterminate hairs noted at the fifth and sixth study months. The number of indeterminate hairs begin to plateau at the seventh to eighth months (Fig. 2), at the very time that terminal hair counts began to peak (Fig. 1) and objective hair growth was visible. These features represent a partial reversal of the balding process and a progression from vellus to terminal hairs under the influence of topical minoxidil. The previous report! suggested that the patient most likely to manifest progressive hair growth with topical minoxidil solution would be one who had recently begun to bald «5 years) and who had a small diameter of vertex baldness « 10 cm)

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and a large number of indeterminate hairs (> 100) in the center of the balding area. That study indicated that the 2% or 3% solutions of topical minoxidil would be efficacious on a subject fulfilling those criteria. REFERENCES 1. De Villez RL. Topical minoxidil therapy in hereditary androgenetic alopecia. Arch DermatoI1985;121:197-202. 2. Olsen EA, Weiner MS. Delong ER, Pinnell SR. Topical minoxidil in early male pattern baldness. JAM ACAD DERMATOL 1985;13:185-92. 3. Hamilton JB. Patterned loss of hair in man: types and incidence. Ann NY Acad Sci 1951;53:708-11.

DISCUSSION Question. Are there any questions or comments? Answer. I think what was said about appearance and number of hairs is pertinent. It is possible that increases in number of hairs may not be as important as changes

in diameter. In these studies we are not measuring hair diameter but classifying hairs as terminal, vellus, etc. It may be that there is asignificant change in the volume of hair that is very important in terms of cosmetic appearance. Question. Is there a baseline number of nonvellus hairs that can be considered predictive of a cosmetically acceptable response? Answer. If you review the data from the group of 56 patients we treated, anyone who had> 150 indeterminate hairs in the 2.5 cm circle at baseline had a good result. In retrospect this was part of the criteria used for patient selection for the continuation study. There were 120 patients in the continuation study and the three criteria for entry were: (1) they had to have type III or IV vertex baldness, (2) they had to have at least 150 indeterminate hairs per 2.5 em circle, and (3) they had to have a balding area of < 10 cm in diameter. All of them had well over 200 indeterminate hairs at the start. This gives some predictability to the response.