Nummular dermatitis is a rare type of dermatitis that affects the skin.
This is an investigator initiated, single center, prospective, double-blind, placebo-controlled phase IIa trial. Thirty-eight patients with clinically and laboratory-proven histopathologically and clinically confirmed nummular eczematous dermatitis will participate in this study.
Both the active and placebo arm of this study will have a two-week, open-label period. In the active arm of the study, a moisturizing lotion containing zinc oxide and petrolatum is given by mouth in combination with regular topical corticosteroid cream. The treatment is intended to reduce the production of sebum and protect the skin from further irritation from the irritation that occurs when eczema is present.
During this phase of the study, patients are to have no restrictions in using the medication and the treatment plan is not required. Any patients with allergies should notify the study physician before starting the study medications. Patients should also inform the study physician about any changes in their medical history, symptoms, medications, and current treatments such as steroids or antibiotics. Patients should ask their physician or allergist about the use of corticosteroids or antibiotics.
After two weeks, the placebo arm will switch to using the moisturizing lotion and topical corticosteroid cream that are used in the active arm. During this time the patient will not be required to use the moisturizing lotion, topical corticosteroid cream or other medications, unless the need arises.
The patients will need to continue using the moisturizing lotion for an additional one week. After the second week, they will discontinue the moisturizing lotion and topical corticosteroid cream if the condition worsens.
During the third and fourth week of the study, the nummular dermatitis will be evaluated by means of skin biopsy. This biopsy will allow the dermatologist to determine the exact cause and nature of the nummular dermatitis. During the fifth and sixth week of the study, there will be skin biopsies of the elbow and forearm.
At week six, the active arm of the study will end and the placebo arm will start. The placebo arm will undergo a four-week washout period to ensure the effectiveness of the moisturizing lotion and topical corticosteroid cream and any other medications used to treat the nummular dermatitis.
After the fourth week, the placebo arm will switch to the study phase, and the study phase will stop at week eight. At week eight, the study phase will conclude and the final evaluation of the study will conclude. This will be followed by a one-year open-label extension to determine the effectiveness of the moisturizing lotion and topical corticosteroid cream.
In summary, during this phase of the study, patients will be evaluated for clinical improvement, and the effectiveness of the moisturizing lotion and topical corticosteroid cream will be assessed. The study will determine whether or not the treatment is effective for patients with nummular dermatitis.
After the clinical evaluation of the study phase, the conclusion of the study will be reached, and the active arm will be withdrawn from the study.
The placebo arm will receive no further treatment and the study will conclude. At this time the open-label extension will end and the active arm will be closed. This will allow the results from the study to be evaluated by another clinical team.
During the study protocol, the patient and the care provider will be informed about the treatment to be used during the study. These instructions will include the right time frame in which the treatment can be used and the correct dose of the medication and the correct amount of each drug. medication that should be taken. The instructions also contain instructions on how to monitor the progress and what to do if the patient experiences any side effects.
The study protocol will also discuss what to expect during the open label extension. This is a period when the active and placebo arms will be evaluated during the study protocol. During this time the active and placebo arms will be tested again for any improvements that have been made to the study protocol, as well as any changes in the treatment used during the study.
The clinical trials of this study are important because they provide evidence to support the use of this treatment and reduce the chances of the study being biased. It is important to be sure that all participants are treated fairly during the study to reduce the possibility of any adverse side effects that may occur as a result of the treatments being administered in the clinical trials.