Evaluation of clinical efficacy of latanoprost drop 0.005% for the treatment of patients with scalp patchy alopecia

Evaluation of clinical efficacy of latanoprost drop 0.005% for the treatment of patients with scalp patchy alopecia

This study was a double-blind randomized clinical trial with a control group that was performed in phase 3 of the trial. Thirty patients were divided into two groups using simple randomization method (taking out numbers from 01 to 30 from the sealed envelope). The randomization process was performed by the secretary (who was independent of the original researchers). Randomization was performed before a patient entered the study and the intervention was assigned according to his group therapy.

This study was conducted on patients with patchy alopecia who were referred to the dermatology clinic of Bu-Ali Sina Hospital in Sari. Patients were randomly assigned to two groups.The first and second groups received latanoprost drops 0.005% or placebo, respectively. The drug and placebo packaging was completely identical, and the patient, evaluator, and information analyzer were unaware for the patient group.

Patients over 12 years old who suffering from patchy alopecia were included in the study. Exclusion criteria were include liver and kidney diseases, diabetes, autoimmune diseases, and the use of immunosuppressive drugs.

Intervention group: Patients who received topical corticosteroids (clobetasol in isopropyl alcohol) with 0.005% latanoprost drops twice a day. Control group: Patients who received topical corticosteroids with latanoprost placebo twice daily.

The area of scalp with hair loss at the beginning of the study, the end of the first, second and third months was compared with the photo.

Using a simple randomization method, individuals who met the inclusion criteria and completed the informed consent form were assigned to two groups. The procedure was as follows: beads numbered 01 to 30 were placed in a sealed envelope. When a patient met the inclusion criteria and the exclusion criteria, a number was took out from the envelope by lottery. If the number was odd, the patient was assigned to group 1 and if it was even, the patient was assigned to group 2. The randomization process was performed by the department secretary (who was independent of the principal investigators). Randomization was performed when a patient entered the study and the intervention was assigned according to his group therapy. For allocation concealment the envelope containing the numbers was closed again and opened only to enter the next patient to draw lottery.

The patient knew he might be in the intervention or placebo group but did not know which group he was in. The clinical evaluator and the person responsible for the statistical analysis were not aware of the patient group. All patients in the case and control groups received topical corticosteroids (clobetasol in isopropyl alcohol) twice daily, but patients in the case group also received 0.005% latanoprost drop (twice daily) and patients in the control group received placebo (twice a day). Both the drug and the placebo were prepared by the Sinadarou factory, Iran. So that the appearance of the drug dosage form and its content, apart from its active ingredient, were exactly the same. Clobetasol cream was prepared from Daroupakhsh factory, Iran.

All data is shareable after unidentified individuals.

Access period starts 6 months after the results are published

Researchers in academic and scientific institutions

For information on the details of the study without doing new statistical analysis

Sending an email to mrrafati@mazums.ac.ir

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