Comparison of the efficacy of hydrocortisone ointment and flax seed oil on skin eczema of children: A clinical trial study

Determining the effectiveness of hydrocortisone ointment and flax seed oil on skin eczema of children

A phase 2, randomized, double-blind, controlled trial with parallel groups enrolled 92 participants. Randomization was performed using a computer-generated allocation sequence.

This study compares the effect of linseed oil with hydrocortisone ointment for the treatment of eczema in children referred to educational hospitals affiliated to Jundishapur University of Medical Sciences, Ahvaz. For double blinding, patients and researchers are unaware of the type of treatment.

Inclusion Criteria: Age: Children between 2 and 24 months of age will be eligible to participate. Eczema Diagnosis: Children with a confirmed diagnosis of eczema will be considered for enrollment. A minimum duration of one week since the onset of current eczema symptoms is required. Underlying Medical Conditions: Children with well-controlled underlying medical conditions may be included in the study after a thorough evaluation by the research team. Exclusion Criteria: Linseed Oil Use: Children who have used linseed oil within the past week will be excluded from the study.

Randomization and Group Allocation: Children will be randomly assigned to one of two groups: Intervention Group: This group will receive flaxseed oil following a standardized usage guide with dosages determined based on the participants' weight. Control Group: This group will receive hydrocortisone ointment according to standardized guidelines established by a physician's recommendations and approved instructions.

Skin dryness; Stretch marks; Flax seed oil; Hydrocortisone ointment; Skin healing

The research sample was first selected from the research community based on the inclusion criteria. Random assignment to the two test and control groups will be conducted using a blocked randomization technique with four permutation blocks (selected from a table of 24 possible blocks). This method ensures that the number of participants in each group is nearly equal. Blocks are formed based on relevant variables, and within each block, half are assigned to the test group and half to the control group. This approach aims to achieve balanced group sizes.

Double-blind Randomized Clinical Trial The study employs a double-blind randomized controlled trial (RCT) design to minimize bias and ensure the objectivity of the results. This means that neither the participants (children) nor the researchers administering the treatments know which group a participant belongs to. Randomization and Group Allocation Participants are randomly assigned to either the test group (flaxseed oil) or the control group (hydrocortisone ointment) using a randomization process. Treatment Preparation and Masking To maintain blinding, both the flaxseed oil and hydrocortisone ointment are prepared in identical containers and labeled with neutral codes (e.g., "H" for hydrocortisone, "T" for flaxseed oil) by an independent person not involved in the treatment assignment or data collection. Double-blinding Implementation The coded containers are then distributed to the participants according to their group assignment. Researchers who interact with the participants and collect data are also blinded to the treatment groups. This ensures that neither the participants' expectations nor the researchers' assessments are influenced by the knowledge of which treatment a participant is receiving.