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

NCT04210674 | Completed DMC

• 1 other identifier: argan oil
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 3

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

Conditions

Diaper Rash

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Diaper dermatitis severity scores was measured the changes using a visual analogue scale on the enrollment day, third, and seventh day of treatment from enrollment day, third day and at the end of seventh day of the treatment. This grading scale is used to reflect the severity level of the dermatitis according to Davis et al. 1986. Respectively, grade-0 represents healthy normal skin; grade-1 represents slight erythema of the entire diaper area with mild irritation; grade-2 for definite erythema of the diaper area totally or in localized areas, moderate irritation; grade-3 for moderate to severe erythema, with or without oozing, in a generalized pattern and associated with papules, pustules, and extreme irritation; grade-4 in cases of severe and worse erythema involving the entire diaper area associated with oozing papules, pustules, and erosion.

  through consecutive seven days for each participant

Secondary Outcomes (1)

• Potential, or suspected associated risk factors with diaper dermatitis

  through data collection period, an average of six months"

Study Arms (2)

The traditional medicinal product of Argan spinosa oil

EXPERIMENTAL

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.

Other: The traditional medicinal product of Argan spinosa oil

The conventional topical steroid ointment

ACTIVE COMPARATOR

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.

Other: The traditional medicinal product of Argan spinosa oil

Interventions

The traditional medicinal product of Argan spinosa oil 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.

Also known as: The conventional topical steroid ointment

The conventional topical steroid ointment; The traditional medicinal product of Argan spinosa oil

Eligibility Criteria

• Age: 1 Day - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Jordan University of Science and Technology: lead

Study Sites (3)

Al-Ramtha governmental hospital

Irbid, 22110, Jordan

Location

King Abdulla university hospital

Irbid, 22110, Jordan

Location

Princess Rahmeh hospital

Irbid, 22110, Jordan

Location

Related Publications (1)

• 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.

  PMID: 37275956 DERIVED

MeSH Terms

Conditions

Diaper Rash

Condition Hierarchy (Ancestors)

Dermatitis, Irritant; Dermatitis, Contact; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous

Study Officials

• Eman Alsatari, MSN

  Jordan University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: the treatment was distributed with sequentially numbered, sealed, and randomized envelope. The pediatrician, participant, children's caregiver and outcome assessor were not informed about the treatment code.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Child and Adolescent Health

Model Details: All children were randomly divided into two groups to receive either topical steroid ointment or the traditional medicinal product of Argan spinosa oil

Study Record Dates

• First Submitted: December 9, 2019
• First Posted: December 26, 2019
• Study Start: February 1, 2018
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: December 26, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

JO (3)