By anti-inflammatory agent is meant any agent known to reduce inflammation by oral or topical administration and includes both steroidal (e.g. corticosteroids) and non-steroidal (e.g. ibuprofen and its derivatives) compounds. Steroidal compounds are used in a concentration of 0.5 to 2.5% and non-steroidals are used in a range of 1 to 5%. Such anti-inflammatory agents are well known to a physician of ordinary skill. See. e.g., Medical Pharmacology, pp. 331-343 9th Edition (1978). These agents may be orally or topically administered. For ease of administration, simultaneous topical application of minoxidil and the anti-inflammatory agent (undertaken in a combined composition), may be preferred. However, in cases of severe inflammation, oral administration of the anti-inflammatory agent concomitant with topically administered minoxidil may be preferred.
Surprisingly, the present inventor has discovered that there is a chronic inflammatory process, subtending to the hair bulbs, in patterned alopecia, leading to eventual scarring of the lower follicle, making regrowth impossible. The present invention solves this problem by suppressing sub-bulbar inflammation, thus allowing for regrowth.
EXAMPLE 1
Fifteen males with early alopecia were treated with a combination of 2% minoxidil and 1% hydrocortisone in a hydroalcoholic vehicle. The subjects were shampooed weekly and hairs were counted after filtration. Fewer hairs were observed to be shed as treatment progressed. Hair regrowth has been substantially better than with minoxidil alone in comparable cases. The longest period of treatment is 6 months. Hair loss has virtually stopped in all subjects.
EXAMPLE 2
Twenty-six young-adult, balding white males were treated for at least five months with a hydroalcoholic solution containing: (1) 3% minoxidil; and (2) 2.5% hydrocortisone. These subjects were in an early stage of baldness, not exceeding 2 inches in diameter over the vertex.
The combination formulation stimulated hair growth in these subjects within three months. Most of the subjects volunteered comments of surprise that enhancement could be seen as early as two months. These results were compared with the results of a study at the same clinic of 50 patients using 3% minoxidil alone. In the opinion of the investigator, hair growth was seen sooner and on a greater proportion of patients in the group treated with the combination of minoxidil and an antiinflammatory agent.