Diaper RashNCT04210674
Effects of Argan Spinosa Oil in the Treatment of Diaper Dermatitis in Infants and Toddlers
A study testing The traditional medicinal product of Argan spinosa oil in people with Diaper Rash, run by Jordan University of Science and Technology at 3 sites in Jordan.
Trial 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 Read more about this study
- Who is it for?
- Ages 1 day to 24 months
- Conditions the study is for
- Diaper Rash
- What is being tested?
- The traditional medicinal product of Argan spinosa oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 3 sitesJordan
- Study dates
- 1 Feb 2018to 1 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants/toddlers aged two years or younger
- Diagnosed with diaper dermatitis (DD) by a paediatrician at baseline day
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Jordan3 sites
Al-Ramtha governmental hospital
Irbid, 22110
King Abdulla university hospital
Irbid, 22110
Princess Rahmeh hospital
Irbid, 22110
About this study
Official title: Effects of Argan Spinosa Oil in the Treatment of Diaper Dermatitis in Infants and Toddlers: A Quasi-Experimental Trial
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
Read the 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
- Being tested
- The traditional medicinal product of Argan spinosa oil
- Keywords
- Argan oil, Infant, Children, Diaper Dermatitis, Topical Steroid Ointment
- Medical subject headings
- Diaper Rash
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The traditional medicinal product of Argan spinosa oilOther
Also called The conventional topical steroid ointment
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: The traditional medicinal product of Argan spinosa oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through consecutive seven days for each participant
Secondary outcomes (1)
Potential, or suspected associated risk factors with diaper dermatitis
Potential, or suspected to be associated risk factors with diaper dermatitis measured using a structured checklist developed by the researcher based on the literature. Factors include: the characteristics of the infants (age, gender, and weight), and mother or caregiver (age, parity, education level, job, income, nationality and home setting (rural, semi-urban and urban), type of feedings, introduction of solid foods, general state of health of the child, recent antibiotic used before the episode, type of diaper, the number of changing diaper per a day, type of wipes, skin cleansing agents, barrier cream used, frequency of bathing, bowel frequency, history of diaper dermatitis (severity level, medication used in the previous episodes, duration of episode and frequency of diaper dermatitis per month).
Measured: through data collection period, an average of six months"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2019
- Study start1 Feb 2018
- Primary completion1 Jun 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diaper RashStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jordan University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nihaya Al shyab, Jordan University of Science and Technology
- Investigators
- Eman Alsatari, MSN, Principal investigator, Jordan University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04210674
- Sponsor's protocol ID
- argan oil
- Status last verified
- Dec 2019
- First submitted
- 9 Dec 2019
- Last updated
- 26 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37275956
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Argan Spinosa Oil in the Treatment of Diaper Dermatitis in Infants and Toddlers: A Quasi-Experimental Trial
- ClinicalTrials.gov ID
- NCT04210674
- Acronym / sponsor ID
- argan oil
- Conditions
- Diaper Rash
- Keywords
- Argan oil, Infant, Children, Diaper Dermatitis, Topical Steroid Ointment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Jordan University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 26 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| The traditional medicinal product of Argan spinosa oil | Experimental | Other: The traditional medicinal product of Argan spinosa oilThe 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. |
| The conventional topical steroid ointment | Active comparator | Other: The traditional medicinal product of Argan spinosa oilThe 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. |
Who may qualify
- Ages
- 1 day to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Infants/toddlers aged two years or younger
- Diagnosed with diaper dermatitis (DD) by a paediatrician at baseline day
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The traditional medicinal product of Argan spinosa oilAlso: The conventional topical steroid ointmentAll 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 | The conventional topical steroid ointment, The traditional medicinal product of Argan spinosa oil |
Primary outcome
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.
Time frame: through consecutive seven days for each participant
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.
1 secondary outcome
Potential, or suspected associated risk factors with diaper dermatitis
Time frame: through data collection period, an average of six months"
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2019.
- Derived from this study: PubMed 37275956Alsatari 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.
- Individual participant dataSharing planned: No
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Breast Milk Versus Barrier Creams for Diaper Dermatitis in Children Aged 0-24 Months
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eman Alsatari, MSN principal investigator
Jordan University of Science and Technology
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The traditional medicinal product of Argan spinosa oil in people with Diaper Rash, run by Jordan University of Science and Technology at 3 sites in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: through consecutive seven days for each participant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04210674, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2019; AzTrials last refreshed its copy on 8 Nov 2026.