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IRCT20091012002581N10 IRCT 2023-10-28 Tabriz University of Medical Sciences Comparing the efficacy of 0.025% Fluocinolone acetonide with and without 5% caffeine in topical treatment of chronic plaque psoriasis Efficacy of 5% caffeine plus 0.025% Fluocinolone acetonide versus 0.025% Fluocinolone acetonide alone for topical treatment of chronic plaque psoriasis 2023-11-22 anticipated 40 Complete https://irct.ir/trial/73367 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be using sealed envelopes, of which 40 envelopes will be selected in total and will be divided into two groups of 20, including groups A and B. Envelopes will be selected by the operating room nurse who is blind to the study groups. Group A will be the intervention 1 group, group B will be the intervention 2 group, Blinding description: The attending physician and patients will not be informed of the type of drug combination received and the list of drugs received by each patient will be provided to the patient and the researcher responsible for data collection in the form of a sealed envelope. 3 Chronic plaque psoriasis. Intervention 1: Intervention group 1: Patients will receive the prepared cream containing 5% caffeine along with fluocinolone acetonide 0.025%. The creams are distributed in divided doses at the beginning and at the second weekly assessment. The amount of cream used is such that it covers the lesion completely. Intervention 2: Intervention group 2: Patients will receive the prepared cream containing fluocinolone acetonide 0.025%. The creams are distributed in divided doses at the beginning and at the second weekly assessment. The amount of cream used is such that it covers the lesion completely. Yes - There is a plan to make this available What will be shared: Study data is categorized and coded with no identifiable individuals. When: Access to study data after publication of the result is available in the journal. To whom: Anyone interested in using the data can access the study data. Conditions: Study data can be used for comparison with other results. Where to obtain: Refer to the study's scientific or public accountability person for data. How to obtain: The request will be sent by email to person responsible for scientific or public inquiries. Comments:
public Dr. Hamideh Herizchi Ghadim
Dermatology ward, sina Hospital
Tabriz Iran (Islamic Republic of) 5138663134 +98 41 1540 6612 dr.herizchi@yahoo.com Tabriz University of Medical Sciences scientific Dr. Hamideh Herizchi Ghadim
Dermatology ward, sina Hospital
Tabriz Iran (Islamic Republic of) 5138663134 +98 41 1540 6612 dr.herizchi@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Patient age over 7 years No history of immunosuppression or iatrogenic Not using medication or treatment methods to treat psoriasis in the two weeks before the study No history of caffeine allergy Not pregnant or currently breastfeeding Consent to participate in the study 7 years 70 years Both Pregnant or lactating women Aggravation of the disease during the study Joint involvement during the study that requires oral treatment Sensitization while using the drug during the study (such as vesicular rash, erythema, itching, etc.) L40 Psoriasis Treatment - Drugs Treatment - Drugs Intervention group 1: Patients will receive the prepared cream containing 5% caffeine along with fluocinolone acetonide 0.025%. The creams are distributed in divided doses at the beginning and at the second weekly assessment. The amount of cream used is such that it covers the lesion completely. Intervention group 2: Patients will receive the prepared cream containing fluocinolone acetonide 0.025%. The creams are distributed in divided doses at the beginning and at the second weekly assessment. The amount of cream used is such that it covers the lesion completely. The rate of recovery of lesions. Timepoint: Patients will be evaluated at the beginning of the study and at weekly intervals for three consecutive weeks. Method of measurement: Psoriasis area and severity index. Tabriz University of Medical Sciences Approved 2023-08-07 Vice Chancellor for research of Tabriz Univercity of Medical Sciences Vice Chancellor for research, 3rd floor, central office, Tabriz Univercity of Medical Sciences, Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)