I was a boomer lab rat
In the media, newspapers, magazines and internet, there are often ads that try to get subjects for pharmaceutical tests on the human body, such as new treatments that hoped to be FDA approved for certain diseases. “If you suffer from (fill in the disease)...contact us now if you would like to be considered to be a subject for a study to be paid up to $$$ to participate and for expenses.
Medicine has improved at a quick pace and new treatments are tested to make sure that it helps the condition, and causes no harm. That skin diseases can be painful, itchy, and unsightly is something I know from experience.
Reasons for applying
Having been plagued by psoriasis, mainly after the age of 50, it can even cause more stress. It’s a problem few talk about. If one doesn’t want to spend big bucks for biological shots that can lessen your tolerance to infection, most medical plans don’t cover the condition.
The common treatments are creams or lotions with steroids. They do offer some relief, but can be messy, can stain clothing and have to be applied twice a day.
For someone who is not a sufferer, facts are the skin condition is inherited and not contagious, but it looks terrible. People don’t like to talk about it, but at times will stare.
At swimming pools, with my shirt off, friends would ask my wife about the psoriasis on my back, and it is embarrassing. I usually wore a tank top or t-shirt.
As a boomer, a slang term for seniors citizens, I was aware that the test might be a benefit to future sufferers, and I really didn’t have too much to lose.
Application process
Looking for local stories, Facebook, for me in my profession, has been very helpful. Little posts from around the community can become a good feature story.
I saw the ad on Facebook for psoriasis subjects, and decided what the heck. At least I’ll get a story out of it.
I answered the ad and was contacted by Austin Institute for Clinical Research. To make a long story short, after answering questions on the phone, I was to come in and see if I would be a good subject to try an experimental drug on my psoriasis.
“A Phase 3 Efficacy and Safety Study of (medicine) for the Treatment of Plaque Psoriasis in Adults,” was the proper name of the study. Hopefully, I would be one of the test subjects.
But after I started the treatments for the first time, about two weeks later my mother died. I could no longer make a few critical appointments in the future; I had to drop out, but the clinic wanted to stay in touch.
A Test Subject again
About two weeks after the funeral, the clinic contacted me once again and asked if I would be willing to start the process again. Yes, I had a flare up, in pain, and agreed, again. Another blood test was given, but only a shortened version of the long mental tests, and no medical paperwork.
The study was a blind test in which neither the doctor or I would know whether it was the test drug or just a placebo; the odds were only one in three for the placebo. The odds were in my favor.
I was instructed to stay out of the sun and cover exposed parts of skin when outside. All my doctors, including my dermatologist were contacted by the clinic and my health information shared. The prescription drugs I was prescribed would not interfere with the study.
I had been taking numerous other vitamins, but that had stopped two weeks before the first visit along with the prescribed steroid creams used for relief.
I would be paid for travel and other expenses around $70 for an in-clinic appointment and $25 for a telephone appointment, all through a prepaid credit card which had deposits one day after an appointment was kept.
I was instructed to go to the clinic in Dripping Springs, their closest location to me. I would be examined every two weeks at appointments during the 12-week period, with a few phone calls only appointments mixed in.
The first visit
When I arrived, I was led to a tiny room that doubled as a storage room, although bright, as it had windows to the outside. It contained an examination bed, and a few chairs with a blood pressure machine/cart/ workstation, a freezer with a lock and shelves of medicine that were locked up in cabinets.
There, I was introduced to a clinic nurse who would be my contact for the duration of the test. She was very pleasant and treated me like a patient, and not a test victim as I anticipated.
To start you out, they give you pages of psychological tests, simple things such as “on a scale of 1 to 10 how do you feel most of the time? 10 is for happy and depressed is 1” and four or five pages of other questions that try to gauge your mental state. There were probably 4o or 5o questions. Of course either extreme can be tricky, as one can be too happy and too sad, but somehow I made it past that part. Pages of medical questions are also asked.
A contract of 23 pages was given to me to read and sign. The sponsoring pharmaceutical company of the drug test was a Swiss company, which to me was impressive, as it would be an international test.
Blood pressure was taken and blood was drawn before using the cream. This is to get a base level of what your blood is made up of, before the application of the experimental cream. My blood was drawn at the middle of and at the end of the testing period.
Tubes of the creams given to me were always numbered and weighed when given and returned. Three tubes were always given, always way more than enough when the cream was to be applied with a thin layer. In two weeks a small tube was hardly used. I turned the tubes in at the next appointment and the used one was weighed and recorded. A few times, new tubes were given and the old ones collected.
For the next twelve weeks I would use only the cream on my outbreaks. This was the absolute worst flare up that had ever been. Due to the stress of my mom and the passing of a very close friend my psoriasis was at its worst point. The oncoming colder season was not going to help.
The colder seasons were always the worst time of the year as it is very dry, and there is loss of sunlight. Vitamin D and lots of sun helps the skin, and colder days and lack of sunlight heightens the condition.
Meeting the Doctor
Then I met my “Investigator (Study Doctor)” — their words — which at first, did make me feel like a lab rat, but I thought, he is a dermatologist and a M.D. He was in his midlate 4os, and had a cool and reserved air. After a few visits though, Dr. Carrasco warmed up and was very pleasant, showing understanding and empathy of my condition, as it was pretty bad.
It was explained that I needed to fill out the time the cream was applied into a daily diary journal, really a couple lines for time and date, which had to be initialed each day in European style Day, Month, Year. There were five or six days on one side of a sheet of paper.
It would be applied at the same time every morning, and I would rate how itchy my psoriasis was the previous day and night on a 1 to 10 scale.
The instructions were that the medicine was to be applied to all areas of psoriasis, my backside, back, groin and the thighs. Without my wife applying it every morning, it would’ve been nearly impossible to see where it needed to be applied.
First Results
At first, I suspected that the numbered cream was the placebo for a few weeks. But very slowly, we’re talking weeks here, a wound dried up, but now with the cream, it also itched like heck. To treat the itch, I was not allowed to apply anything other than cream and the off the shelf body lotion given to me by the clinic. Other than the prescribed medications by my doctors, no vitamins or over the counter medications that treated the disease could be taken.
I was told this was in order to find out how effective the test drug alone was in treating the disease without any other chemicals or treatments affecting my body.
Medical appointments every two weeks were kept and the itch started to plague me, even waking up in the middle of the night itching.
The itch continued throughout the rest of the test weeks. Photos on an iPad were taken of my body, all the breakouts, front and back, and recorded each at every appointment as the weeks went on.
The itch got progressively worse, but slowly the psoriasis began to disappear. I kept at it and applied lotion several times a day. Then about week 9, I suddenly broke out with a burning red rash that was different than the psoriasis.
Unscheduled visit
My itching psoriasis had turned to a bad red rash, hurting to even sit down. I called the clinic and was told to come in. Going in an unscheduled non-paying appointment after a phone call, Dr. Carrasco examined my rash and mentioned eczema, an ailment I never had before, and told me to discontinue the experimental cream. Pictures again were made of every rash area.
Slowly as I discontinued the cream, the red rash disappeared, about two weeks or so later. I suddenly realized the psoriasis had disappeared. After eleven weeks, some sleepless nights and a whole lot of itching, the surprise was on me.
Aftermath
After starting treatment in late September and continuing until December, there were times that the itch was awful. It was at times so bad I had to sleep on my recliner, because I had to let my wife sleep and was constantly scratching.
A warning, if you are shy about taking your clothes off and having photos made of the affected areas, this is not for you. I went in with the attitude that hopefully I could help those in the future who are affected with psoriasis. Oh yeah the money was also welcomed.
Now that it is over, I am very glad I went through all of the daily discomfort and jotting down how bad the itching was. The disease has subsided for now, something I didn’t think could be possible, but it has been non-psoriasis winter season. Fingers crossed, knock on wood.