A clinically controled prospective study with histology:
Psoriasis treatment with DermaZinc™ (compounded with 50 mg micronized Clobetasol Propionate) compared to Clobetasol
Propionate (generic) and Compared to Control Cream
Desiree Eakin, Aniko Grego, Lawrence Moy MD
South Bay Laser Clinic
Abstract: Psoriasis is a common and difficult condition to treat. Corticosteroids and other
agents are often used. Zinc pyrithione has been used for other related conditions. This study compares the use of combined
micronized clobetasol propionate and zinc pyrithione (DermaZinc™ prescription strength) together VS control cream and generic
clobetasol propionate alone. The one month study was double-blind controlled with treatments applied on either side of the body in
a randomized fashion. There were 36 patients enrolled in the study. Of those, one was disqualified due to possible improper usage
of the two test products DermaZinc™ Spray compounded with 50mg micronized Clobetasol Propionate VS generic Clobetasol
Propionate, and three were disqualified due to substantial lapse of time between appointments. The psoriasis was examined for the
following parameters: erythema, scaling, and thickness. The results demonstrate that the DermaZinc™ Spray compounded with
50mg micronized Clobetasol Propionate was significantly more effective than the generic clobetasol propionate alone for each
parameter. In addition, the DermaZinc™ Spray compounded with 50mg micronized Clobetasol Propionate cleared lesions faster
compared to generic Clobetasol Propionate. We conclude that there is a synergistic effect of using corticosteroids with zinc
pyrithione in the treatment of psoriasis.
Psoriasis is a dermatologic condition notable by papulosquamous plaques on the
extremities, trunk, and scalp. The plaques are characteristically very thick with marked erythema or "salmon" colored.
The scaling on the surface is typically very pronounced and powdery with significant adherence. Psoriasis has been estimated to be
prevalent from 1.5% to 2.5% of the total population. The cause of psoriasis is not known. It has been suspected that the psoriasis
has an immunological mechanism that causes the lesions.
Topical therapies for psoriasis has included corticosteroids, tars, anthralins and keratolytics. Newer therapies include vitamin
D analogs, new anthralin preparations and topical retinoids. Additional therapies include the use of exposure to ultraviolet light,
which may be used alone, or as an adjunct to several other therapies.
Zinc pyrithione has been used for a variety of conditions, including seborrheic dermatitis and dandruff. Zinc pyrithione has
also been shown in some studies to reduce epidermal proliferation of test animals.
The purpose of the study is to compare the clinical efficacy of combining zinc pyrithione DermaZinc™ Spray compounded with
50mg micronized Clobetasol Propionate to generic Clobetasol Propionate and to a negative control on the treatment of psoriasis.
Method and Materials
The study was conducted in a double-blind format consisting of the
randomized application of either the DermaZinc™ Spray compounded with 50mg micronized Clobetasol Propionate on one side of
the body and on the other side of the body, either the generic Clobetasol Propionate or negative control cream. The patients were
accepted into the study with moderate to severe psoriasis with at least 15% body surface area involvement. The lesions had moderate
to severe standings in scaling, thickness, and erythema of the psoriatic lesions.
The patients were given an instruction sheet and a written psoriasis
evaluation. The dermatologist then examined the skin using a standardized psoriatic parameter score sheet. The 35mm photography
were taken. The follow-up visit was in one month.
The evaluation form will ask the patient to evaluate the skin with
a scale from 0-3. The skin parameters for evaluation will include: scalyness of the lesions, redness of lesions, thickness of the
lesions, pruritis, body surface area involved.
A board-certified dermatologist examined the psoriasis for the following characteristics: hyperkeratoses (scaling), erythema,
thickness and body surface area affected. The parameters for each characteristic was at 0 to 3 with 0 being no residual amount of
the characteristics, 1 being mild amount, 2 being moderate amount, and 3 being severe or marked amount.
The biopsies were performed on the perilesional region of the
psoriasis using standard 3mm biopsy technique and the tissue material will be immediately placed into 10% formalin. The skin was
closed with a 5-0 nylon suture to be removed in 7 days.
The double-blind controlled study on the use of DermaZinc™ Spray compounded with
50mg micronized Clobetasol Propionate, generic Clobetasol Propionate, and control vehicle demonstrated a significant improvement.
The study was based on standardized evaluation scores based on erythema, scaling and thickness of the examined lesions. For each
parameter, the DermZinc™ Spray compounded with 50mg micronized Clobetasol Propionate improved significantly better than the
other products tested.
The DermaZinc™ Spray compounded with 50mg micronized Clobetasol Propionate improved the evaluations scores for erythema
by 1.50, the scaling scores by 1.84, the thickness scores by 1.74, and the overall score of 5.08. The generic Clobetasol
Propionate, improved the evaluation scores for erythema by 0.81, the scaling scores by 1.09, the thickness scores by 1.12, and the
overall score by 3.02. The control vehicle product improved the evaluation scores for erythema by 0.39, the scaling scores by 0.69,
the thickness scores by 0.61, and the overall score by 1.69.
The scores for all the parameters, erythema, scaling, and thickness, and the overall scores were significantly different for the
DermaZinc™ Spray compounded with 50mg micronized Clobetasol Propionate in comparison to the generic Clobetasol Propionate
(p<0.05) and to the Control (p<0.02).
The double-blind study clearly demonstrates that the DermaZinc™ Spray
compounded with 50mg micronized Clobetasol Propionate is substantially more effective than generic Clobetasol Propionate for
psoriasis over a one month treatment time. From the study, we found that the DermaZinc™ Spray compounded with 50mg micronized
Clobetasol Propionate is one of the most effective single products for psoriasis. The product was significantly more effective in
reducing erythema, thickness, scaling, and the overall psoriasis lesion. As expected, the Control Cream was marginally effective.
The application of a lotion has been known to be mildly effective for psoriasis. In addition, the generic Clobetasol Propionate was
significantly effective in improving psoriasis as has been demonstrated in other studies.
The DermaZinc™ Spray contains synergistic combination of zinc pyrithione and micronized Clobetasol Propionate. The zinc
pyrithione probably improves the psoriasis because of its effect on decreasing cell proliferation and has been demonstrated to work
on related conditions. There may also be a potentiating benefit of the zinc pyrithione of assisting the Clobetasol Propionate's
effect on psoriasis.
Because of the rapid results of DermaZinc™ Spray compounded with 50mg micronized Clobetasol Propionate, the patient does
not need to use potent steroids for as long as other steroid products, increasing the overall therapeutic safety of the topical
steroids. More studies will be conducted to evaluate whether DermaZinc™ Spray compounded with 50mg micronized Clobetasol
Propionate increases psoriatic remission.