Within three months of starting treatment, most participants noticed they were shedding less hair.
Within six months of starting treatment, most had improved hair density.
To follow up on this pilot study, Sinclair has begun phase II clinical trials.
He expects those trials to wrap up within six months.
“Once we have the results from the phase II trials,” he said, “we plan to approach the FDA Centre for Drug Evaluation for a pre-IND [investigational new drug] meeting to map out the path for evaluation and development of this treatment so that is can be made available to women affected by hair loss in the U.S. and worldwide.”
Most reported side effects were mild
This pilot study makes a solid contribution to the field of female pattern hair loss, Dr. Amy McMichael, chair of dermatology at the Wake Forest School of Medicine, told Healthline.
“I believe this is a solid article that adds a lot to the literature,” McMichael said.
“His use of an accepted visual scale is helpful in determining the improvement [in hair shedding and density] in a scientific manner,” she added.
To visually assess hair shedding and density among participants, Sinclair’s team used clinical grading scales that he had developed and validated in previous studies.
They also checked for side effects by asking participants about potential symptoms, checking their blood pressure at each visit, and conducting regular blood tests.
Eight of the women who took part in the study developed side effects, including hives, facial hair growth, or low blood pressure when standing.
But these side effects were generally mild, and only two women stopped treatment early.
To limit the risk of side effects associated with oral minoxidil, Sinclair and his team administered it in low doses.
Nonetheless, some patients may need to adjust their medication regimen before adding minoxidil or spironolactone to it.
“Both minoxidil and spironolactone are prescription medications, with a number of drug interactions. People already undergoing treatment for high blood pressure, fluid retention, or palpitations may require modification of their existing medications,” Sinclair cautioned.
