Clinical trial NCT04210674: Effects of Argan Spinosa Oil in the Treatment of Diaper Dermatitis in Infants and Toddlers
Official title: Effects of Argan Spinosa Oil in the Treatment of Diaper Dermatitis in Infants and Toddlers: A Quasi-Experimental Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diaper Rash
Keywords: Argan oil
Infant
Children
Diaper Dermatitis
Topical Steroid Ointment
Lead sponsor: Jordan University of Science and Technology
Sponsor class: OTHER
First posted: 2019-12-26
Enrollment: 150
Sex: ALL
Minimum age (years): 1
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Infants/toddlers aged two years or younger
2. Diagnosed with diaper dermatitis (DD) by a paediatrician at baseline day

Exclusion Criteria:

1. Physical history of co-morbidities
2. Disorders that require special treatment (kidney disorders, malignancy, oral or genital thrush, psoriasis, on high protein diets or minerals deficiencies such as zinc deficiency)
3. Use of oral antibiotics therapy or topical non-steroidal anti-inflammatory drugs
4. Participation in another study
5. Allergic history to the active ingredients of trial medications.

Primary outcomes:
measure: Mean Changes from Baseline in diaper dermatitis severity scores using the traditional medicinal product of Argan spinosa oil versus the conventional topical steroid ointment from enrollment day, third day and at the end of seventh day of the treatment.
timeFrame: through consecutive seven days for each participant
Secondary outcomes:
measure: Potential, or suspected associated risk factors with diaper dermatitis
timeFrame: through data collection period, an average of six months"
Other outcomes:
Locations:
city: Irbid
country: Jordan
facility: Al-Ramtha governmental hospital
city: Irbid
country: Jordan
facility: King Abdulla university hospital
city: Irbid
country: Jordan
facility: Princess Rahmeh hospital
Study officials:
affiliation: Jordan University of Science and Technology
name: Eman Alsatari, MSN
role: PRINCIPAL_INVESTIGATOR
References: