Propecia Results

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PROPECIA Clinical Trials

To find out if PROPECIA does really work for men with male pattern hair loss, two 1 year clinical trials were conducted on 1553 men with mild to moderately severe male pattern hair loss. The trials were conducted in 16 countries around the world.

The men in the trial:
The men enrolled for the trial were aged from 18 to 41 years. They all had hair loss, and ranged from mild to moderately severe – stage II to V on the Norwood-Hamilton scale.
Placebo-controlled – men in the trial were divided into two groups. One group received genuine PROPECIA, the other received dummy pills that looked identical to PROPECIA.
Double-blind – the packets of pills were coded but otherwise unmarked, so neither the patient nor the doctor knew whether the pills they were using were PROPECIA or dummy pills (placebo).
Randomised – the doctors and men in the study did not know whether they were going to receive PROPECIA or placebo. This was randomly assigned at the start.
Multicentre – the trials were carried out in different centres around the world.

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The trial process
Once in the trial, patients were not allowed to alter their hairstyle, or dye their hair. At the start, all patients were given placebo pills for a two week run-in. This helped them into the habit of taking pills once a day.

All patients used the same shampoo throughout the trials (Neutrogena T Gel). Once started on a course of pills, patients visited the clinic every three months, where they were assessed.

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Patients were evaluated using the following assessments:

Hair Counts

Researchers counted the number of hairs men gained or lost from a small area of clipped hair (cut to 1mm in length) at the front of their head. This was done using microphotographs (extreme close-ups) of the area taken with a specialised camera system, preset for focus, distance (primary magnification 1:1.7) and exposure. A dot tattoo placed in the middle of the clipped area was used to centre the photographs. Photographs from the start, at 6 months and at 12 months were converted in to dot maps of each visible hair, and hair counts were made using scanners and imaging software.

Patient Self Assessment

Patients completed questionnaires consisting of 4 questions about their treatment’s effectiveness, and three questions about their satisfaction with their own appearance.

Investigator Assessment

The doctors conducting the trial (investigators) assessed patients using a standardised rating for hairgrowth – from –3 (greatly decreased) to +3 (greatly increased).

Global photographic assessment

3 dermatologists experienced in photographic assessment of scalp hair growth reviewed standardised colour photographs from test centres around the world.

The dermatologists did not know which patients had received PROPECIA and which had received placebo (they were ‘blinded’). They graded each photograph using the same rating as the investigators (see previous screen).

Safety Measurements

These included adverse event reports and clinical and laboratory evaluations.

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