Research Study
ALOPECIA
AREATA RESEARCH STUDY
TOPICAL
APPLICATION OF ALDARA 5% CREAM
UNIVERSITY OF MINNESOTA, MINNEAPOLIS
DEPARTMENT OF DERMATOLOGY
Thank
you for your interest in the following alopecia areata research studies
sponsored by 3M Pharmaceuticals and
funded in part by a research grant from
the National Alopecia Areata Foundation (NAAF).
The
studies are being conducted at the University
of Minnesota in Minneapolis and coordinated by the Clinical Research
Division in the Department Of
Dermatology. The investigators include:
These
research studies are examining the relationship between alopecia areata and the
way inflammatory cells function that are present around the hair follicle.
In
the first study, you will be asked to apply Aldara Cream 5% to the right side of
your scalp on a daily basis in the evening for approximately 6 months. Seven
clinic visits will be required within the period of 6 months. Photographs will
be taken of the scalp and two 4 mm punch biopsies will be taken from the right
parietal scalp, approximately two inches above the ear. This will be done at the
end of the study also (week 26). You will be asked to return in 10-14 days for
suture removal. You will also be asked to return at week 6, 10 and 18 so your
scalp may be evaluated and any adverse experiences with the medications may be
reviewed.
In
the second study (you must be a participant in the first study), you will give
two additional biopsies at the first visit and at the 26-week visit. You will be
asked to return in 10-14 days after the biopsy for suture removal and a wound
check. This study will look at skin biopsies of the scalp in subjects who are
using Aldara 5% cream to:
- Determine the quality and state of the hair follicles as well as the inflammation around
the hair follicle with the use of Aldara 5% Cream.
- Examine the quality and state of the activity of the immune cells in biopsies of those
individuals using Aldara 5% Cream.
You will receive $25.00 for each punch biopsy taken.
You will be excluded from the study if you:
- Are less than 18 years of age
- Have < 95% scalp hair loss (we are seeking to enroll participants who have at least
95% or greater hair loss, such as those with alopecia totalis or universalis)
- Have a history of any illness or condition that might confound the results of the study
or pose additional risk in administering the drug
- Have significant abnormalities on the clinical screening examination
- Have previously used Aldara 5% Cream
- Have a history of drug or alcohol abuse
- Have used
ultraviolet radiation, including tanning beds and PUVA therapy for the treatment
of acne, psoriasis, or any other skin condition, within 2 months prior to study
initiation
- Have used
systemic or topical glucocorticoids, corticosteroids, estrogenic, progestogenic,
androgenic, or antiandrogen drugs, cyclosporine, FK506 (tacrolimus) or topical
immunotherapy with DNCB, SADBE, or DPCP within 6 months of study initiation
- Are a pregnant or nursing female
- Have used a topical medication on the scalp within six weeks prior to the study
If you would like to be a participant, or have further questions about these
studies, please call Lynn Steiner, MD at 612-625-5925 or email Dr. Steiner at stein109@tc.umn.edu.
Thank you for your interest in furthering alopecia areata research.
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