Effects of Argan Spinosa Oil in the Treatment of Diaper Dermatitis in Infants and Toddlers
Condition: Diaper Rash
MeSH terms: Dermatitis; Diaper Rash
Study type: Interventional

Summary: 
      The study hypothesized that using the traditional medicinal product of Argan spinosa oil is
      more effective than conventional topical steroid ointment on the speed up of the healing
      process and alleviation the symptoms in children with diaper dermatitis after seven
      consecutive days of the treatment
    

Detailed description: 
      Non-probability convenience sampling technique was used. Before the sampling started, a
      randomization plan was developed using the Statistical Package for the Social Sciences
      (SPSS).

      Treatment Approach Initial and Follow up Visits The pediatrician did the initial consultation
      and evaluation in a private room that assured child information privacy at the baseline day
      in order to determine the DD severity level using the 5-point grading scale, after that
      he/she prescribed the treatment with sequentially numbered, sealed, and randomized envelope.
      The pediatrician was not informed about the bottles code, and then the researcher conducted a
      face-to-face interview in a private room with parents of children who were included in the
      study. The interviews were guided by a structured checklist were developed based on
      literature by the researcher. The checklist collected information regarding 27 variables that
      are potential, or suspected, to be associated with risk factors with DD.

      The researcher talked to children's caregivers, explained the study process and provided
      general consistent tips to the all of them, including firstly washing the affected area only
      with warm water, disposing the area to the fresh air and keep the area dry; secondly
      spreading the prescribed trial medications on the affected area sparingly over the lesions
      borders forth times per day, then diaper the baby; finally not to apply any on the affected
      area such as wet wipes, essence contained soaps, barrier cream or other medications during
      the seventh day of the trial. The home follow-up visits took place and the researcher
      re-evaluated diaper area using the 5-point grading scale in the first, third and seventh day
      of trial.

      Treatment Intervention Organic Argan Spinosa Oil was available in different specialist stores
      in Northern Jordan, the samples were produced in Pakistan, according to the certificate
      information of the product, the content is organic Argan Spinosa Oil and it was extracted in
      August 2017 from the hardcore of the fruit by a traditional hand cold-press method. The
      composition of the oil as shown on the bottle label was: Campesterol (0.2%), Avenasterol
      (4.1%), Beta-tocopherol (.1%), Gama tocopherol (86.5%), Delta tocopherol (7.0%),
      Alpha-tocopherol (5.5%), Spinasterol (44.4%) and Tocopherol Totaux (738 mg/kg). The oil
      samples were carefully handled to avoid contamination and correctly stored and maintained in
      brown glass sealed bottles.

      Topical hydrocortisone 1% ointment was purchased from different pharmacies in Northern
      Jordan, the samples were produced in Jordan by Hayat Pharmaceutical Industries, according to
      the certificate information of the product, the content is Econazole Nitrate 1% and
      Triamcinolone Acetonide 0.1% and it was produced in March 2017.

      All medications were randomly coded by the researcher as "A" for Argan Spinosa Oil and "B"
      for topical hydrocortisone 1% ointment, then provided to the assessed Pediatrician (who was
      not aware of the bottles cod) with sequentially numbered, sealed, and randomized. Children's
      Caregivers were instructed to apply sparingly to the affected areas forth times per day for
      both groups for planed seven consecutive days. The volume of medications was varied depending
      on child weight and age.
    

Intervention name(s): The traditional medicinal product of Argan spinosa oil
Intervention type(s): Other
Intervention description(s): All children were randomly divided into two groups to receive either the traditional medicinal product of Argan spinosa oil or The conventional topical steroid ointment.
Other intervention name(s): The conventional topical steroid ointment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: All children were randomly divided into two groups to receive either topical steroid ointment or the traditional medicinal product of Argan spinosa oil
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Argan oil; Infant; Children; Diaper Dermatitis; Topical Steroid Ointment