Effects of Argan Spinosa Oil in the Treatment of Diaper Dermatitis in Infants and Toddlers

NCT ID: NCT04210674

Last Updated: 2019-12-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-01
• Study Completion Date: 2019-06-01

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.

Conditions

Diaper Rash

Keywords

Argan oil; Infant; Children; Diaper Dermatitis; Topical Steroid Ointment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

The traditional medicinal product of Argan spinosa oil

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 traditional medicinal product of Argan spinosa oil 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.

Group Type: EXPERIMENTAL

The traditional medicinal product of Argan spinosa oil

Intervention Type: OTHER

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.

The conventional topical steroid ointment

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 conventional topical steroid ointment 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.

Group Type: ACTIVE_COMPARATOR

The traditional medicinal product of Argan spinosa oil

Intervention Type: OTHER

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.

Interventions

The traditional medicinal product of Argan spinosa oil

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.

Intervention Type: OTHER

Other Intervention Names

The conventional topical steroid ointment

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.

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 24 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jordan University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Nihaya Al shyab

Associate Professor of Child and Adolescent Health

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eman Alsatari, MSN

Role: PRINCIPAL_INVESTIGATOR

Jordan University of Science and Technology

Locations

Al-Ramtha governmental hospital

Irbid, , Jordan

King Abdulla university hospital

Irbid, , Jordan

Princess Rahmeh hospital

Irbid, , Jordan

Countries

Jordan

References

Alsatari ES, AlSheyab N, D'Sa JL, Gharaibeh H, Eid S, Al-Nusour EA, Hayajneh AA. Effects of argan spinosa oil in the treatment of diaper dermatitis in infants and toddlers: A quasi-experimental study. J Taibah Univ Med Sci. 2023 May 22;18(6):1288-1298. doi: 10.1016/j.jtumed.2023.05.008. eCollection 2023 Dec.

Reference Type: DERIVED

PMID: 37275956 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan: Results

View Document

Document Type: Informed Consent Form

View Document

Document Type: Study Protocol and Statistical Analysis Plan: Result of the study

View Document

Other Identifiers

argan oil

Identifier Type: -

Identifier Source: org_study_id