Efficacy of topical herbal cream formulation consisting of borage, evening primrose, calendula and, leeks versus topical mometasone 0.01% in the treatment of atopic dermatitis

Comparison of the effect of herbal cream formulation consisting of borage, evening primrose, calendula, and leeks with topical mometasone 0.01% t in the treatment of atopic dermatitis

Phase-3 double-blind randomized controlled trial, with parallel groups on 62 patients. Simple randomization will be performed using a table of random numbers

Patients with atopic dermatitis will be selected based on the inclusion and exclusion criteria from those attending the Dermatology Clinics of Al-Zahra and Sedighe Tahereh Hospitals affiliated with Isfahan University of Medical Sciences. Patients will be randomized into two groups using simple randomization. The two drugs will be prepared in similar shape and form by a colleague (blinding of the patients) and delivered to the visiting physician so that the physician will also be blinded to the groupings. Patients will receive treatment daily for a month and the drug will be tapered within the next month. All patients will be visited 4 times (weeks 0, 4, 8, and 16) by the physician and will be evaluated regarding SCORAD score. Also, patients will be asked to rate their satisfaction with treatment from 0 to 10 at 4, 8, and 16 weeks using visual analogue scale (VAS).

Inclusion criteria: Age >7 years SCORing Atomic Dermatitis (SCORAD) score <50 Exclusion criteria: Accompanying physical illness Any physical illness preventing drug administration Treatment in the past 6 months Drug use or alcohol consumption in the past 6 months Pregnancy or lactation Lack of following up by the patient Severe drug hypersensitivity

One group a herbal combination cream and the other group topical mometasone

Improvement in SCORing Atopic Dermatitis (SCORAD) score

Individual simple randomization using a table of random numbers generated by the Random Allocation software by a statistician unaware of the study. To perform allocation concealment, the same statistician will write the name of the groups on a piece of paper and put them in numbered envelopes based on the randomization table. The envelopes will then be sealed. Patient recruitment will be done by the investigator blinded to the content of the envelopes. An envelope will be allocated to each patient upon entering the study and the investigator will be unaware of which group the next patient will be allocated to.

The physician responsible for lesion assessment will be blinded to the grouping of patients. Both drugs will be available in unidentifiable forms to the patients.