Effect of a topical Boswellia-based cream (Persian Medicine product) on skin manifestations and quality of life in mild to moderate plaque psoriasis

The effect of a topical Boswellia carterii-based cream (Persian Medicine product) on the skin manifestation in mild to moderate plaque psoriasis

Randomized clinical trial of 108 patients in intervention and control groups, parallel groups, double blind.

Individuals are randomly divided into two groups of intervention and placebo and treated with topical cream for one month at the clinic of Center for Research and Training in Skin Diseases And Leprosy in Tehran. The physician and patients are blind.

Inclusion: 1. 18-70 years 2. Diagnosed with clinical of mild to moderate plaque psoriasis; 3. PASI score <12 4. Involvement of body surface area< 10%; 5. Patients who provide written informed consent; Exclusion: 1. Pregnant or breast-feeding females; 2. Known allergic reactions to components of the study medication; 3.Quttate, erythrodernic, or pustular psoriasis at the time of screening or patients with psoriasis vulgaris with face involvement only; 4.Use of drugs that aggravate psoriasis such as beta-blockers, anti malaria, terbinafine, calcium channel blockers, interleukin and lithium; 5. Previous treatment with biologic or immunosuppressive drugs, systemic corticosteroids and ultraviolet B phototherapy after taking psoralen within the previous four weeks; 6.Previous treatment with topical corticosteroids within the previous two weeks; 7. Severe psoriasis; 8. Patients who require systemically acting medications; 9. Presence of an infectious ulcer or cancer in the treatment area;

Intervention group uses 1 gr of topical cream on the skin lesion twice daily for a 4-week (28 days). The control group also uses the same cream in the same dose.

PASI score (psoriasis area and severity index) , PGA score (physician global assessment)

In this study, randomly permuted blocks of size 6 are used to assign participants into two groups (treatment and placebo groups). There are 108 participants in this study and as a result, 18 blocks of size 6 is considered. With blocks of size six, for example the order in which the integers 1,2,3,4, 5, 6 appear in a random permutation determines which patients receive the treatment (those whose numbers appear first, second and third) and which receive the placebo (those whose numbers appear fourth, fifth and sixth). For example, if numbers appear in the order of 4, 1, 6, 3, 2 and 5, the assignment of participants to the study groups will be as follows: Placebo, Treatment, Placebo, Treatment, Treatment, and Placebo. This procedure will be performed to obtain all 18 blocks of size six (1). Fleiss JL. Design and analysis of clinical experiments: John Wiley & Sons; 2011.

Participant, physician, clinical care, researcher and outcomes evaluation are blind in this study .According to the drug and placebo are similar in appearance, color, weight, smell, and manner of use.

Skin lesions and quality of life database will be share in patients with mild to moderate psoriasis.

" The results will be available 6 months after printing"

Researchers working in academic and scientific institutions and those involved in the pharmaceutical industry.

They make the low risk drug.

Fateme Fadaei , The University of Tehran, Ahmadiyyeh Persian Medicine Clinic. f-fadaei@razi.tums.ac.ir

First, they will send an application to Mrs. Dr. Shirbeigi, then they will have access to the documentations after review for 6 months, if agreed necessary. l.shirbeigi@yahoo.com