Childhood Atopic DermatitisNCT02084472
Accessible and Affordable Moisturizers for Atopic Eczema
A study testing Baby oil, petroleum jelly and Glycerine:petroleum jelly 2:1 in people with Childhood Atopic Dermatitis, run by Red Cross War Memorial Childrens Hospital at 1 site in South Africa.
Trial summary
Aqueous (EUA) cream, cetomacrogol (CMG) and emulsifying ointment (HEB) are in South Africa's essential drug list (EDL) but are not available to most rural patients. To assess whether accessible moisturizers can be used as alternatives in atopic eczema (AD), a randomized controlled trial of patients with… Read more about this study
- Who is it for?
- Ages 6 months to 12 years
- Conditions the study is for
- Childhood Atopic Dermatitis
- What is being tested?
- Baby oil, petroleum jelly and Glycerine:petroleum jelly 2:1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSouth Africa
- Study dates
- Feb 2013to Jul 2013
- 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 6 months to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients with Atopic dermatitis as defined by the united kingdom (UK) Working party Diagnostic Criteria
- Atopic Dermatitis patient with mild to moderate stable atopic eczema with parents/guardians willing and able to apply study moisturizers as directed and commit to attend all visits.
Who cannot join
- Less than 1 year of age
- Patients with atopic dermatitis treated with systemic preparations
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Red Cross War Memorial Children's Hospital
Cape Town, Western Cape, 7700
About this study
Official title: Accessible and Affordable Moisturizers for Atopic Eczema: the 2am Atopic Eczema Study
Aqueous (EUA) cream, cetomacrogol (CMG) and emulsifying ointment (HEB) are in South Africa's essential drug list (EDL) but are not available to most rural patients. To assess whether accessible moisturizers can be used as alternatives in atopic eczema (AD), a randomized controlled trial of patients with mild-to-moderate AD, aged 1-12 years was conducted. Two separate sub-studies were conducted using a randomized controlled single (assessor) blind trial design. Study 1 compared UEA vs. liquid paraffin (unscented baby oil) for baths, all patients used HEB as moisturiser. In Study 2, 4 moisturisers were compared -HEB, CMG, petroleum jelly and petroleum jelly/Glycerine (2:1). Assessments (SCORAD, POEM, NESS and IQDOL) carried out at baseline, week 4, 8 and 12. Routine topical steroids and antihistamines were continued as prescribed.
- Conditions
- Childhood Atopic Dermatitis
- Being tested
- Baby oil, petroleum jelly, Glycerine:petroleum jelly 2:1
- Keywords
- atopic eczema, moisturisers, alternatives, affordable
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baby oilOther
Also called unscented liquid paraffin
patient in study 1, arm B washed unscented liquid paraffin (baby oil) in place of aqueous cream
petroleum jellyOther
patients in this arm, use petroleum jelly (vaseline), replacing emulsifying ointment as a moisturiser
Glycerine:petroleum jelly 2:1Other
patients in this arm use glycerine and petroleum jelly mixed at a ratio of 2:1 in place of cetomacrogol as a moisturiser
| Study group | Role | What they receive |
|---|---|---|
| study 1: aqueous cream and baby oil | Active comparator | enrolled patients in this arm use either aqueous cream or baby oil as a soap substitute Receives: Other: Baby oil |
| study 2: emulsifying ointment and cetomacrogol | Active comparator | patients in this study arm continue to use emulsifying ointment and cetomacrogol as a moisturiser, the current standard of care in our institution Receives: Other: petroleum jelly; Other: Glycerine:petroleum jelly 2:1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the validated SCORing Atopic Dermatitis(SCORAD)
Change in the validated SCORing Atopic Dermatitis(SCORAD) and two other validated clinical scores (Nottingham Atopic Eczema Severity Score(NESS) and Patient Oriented Eczema Measure(POEM) were used to measure the extent/severity of AD. A validated quality-of-life form using the infants dermatitis quality of life (IDQOL) scale was completed by each care-giver at each visit.
Measured: Baseline, week 4, 8 and week 12
Secondary outcomes (1)
Change in the patient quality-of-life as measured by the infants dermatitis quality of life (IDQOL) index at each visit.
Measured: Baseline, week 4, 8,12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2014 (estimated)
- Study startFeb 2013
- Primary completionMay 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood Atopic DermatitisStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Red Cross War Memorial Childrens Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Carol Hlela, Red Cross War Memorial Childrens Hospital
- Investigators
- Nonhlanhla Khumalo, MD, PhD, Study director, University of Cape TownCarol Hlela, MD, PhD, Principal investigator, Red Cross War Memorial Childrens Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02084472
- Sponsor's protocol ID
- 146/2013
- Status last verified
- Mar 2014
- First submitted
- 3 Mar 2014
- Last updated
- 12 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accessible and Affordable Moisturizers for Atopic Eczema: the 2am Atopic Eczema Study
- ClinicalTrials.gov ID
- NCT02084472
- Acronym / sponsor ID
- 146/2013
- Conditions
- Childhood Atopic Dermatitis
- Keywords
- atopic eczema, moisturisers, alternatives, affordable
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Red Cross War Memorial Childrens HospitalUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- May 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 12 Mar 2014 (estimated)
- 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.
Aqueous (EUA) cream, cetomacrogol (CMG) and emulsifying ointment (HEB) are in South Africa's essential drug list (EDL) but are not available to most rural patients. To assess whether accessible moisturizers can be used as alternatives in atopic eczema (AD), a randomized controlled trial of patients with mild-to-moderate AD, aged 1-12 years was conducted. Two separate sub-studies were conducted using a randomized controlled single (assessor) blind trial design. Study 1 compared UEA vs. liquid paraffin (unscented baby oil) for baths, all patients used HEB as moisturiser. In Study 2, 4 moisturisers were compared -HEB, CMG, petroleum jelly and petroleum jelly/Glycerine (2:1). Assessments (SCORAD, POEM, NESS and IQDOL) carried out at baseline, week 4, 8 and 12. Routine topical steroids and antihistamines were continued as prescribed.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study 1: aqueous cream and baby oil | Active comparator | Other: Baby oilenrolled patients in this arm use either aqueous cream or baby oil as a soap substitute |
| study 2: emulsifying ointment and cetomacrogol | Active comparator | Other: petroleum jelly, Other: Glycerine:petroleum jelly 2:1patients in this study arm continue to use emulsifying ointment and cetomacrogol as a moisturiser, the current standard of care in our institution |
Who may qualify
- Ages
- 6 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Patients with Atopic dermatitis as defined by the united kingdom (UK) Working party Diagnostic Criteria
- Atopic Dermatitis patient with mild to moderate stable atopic eczema with parents/guardians willing and able to apply study moisturizers as directed and commit to attend all visits.
Key exclusion criteria (2 listed)
- Less than 1 year of age
- Patients with atopic dermatitis treated with systemic preparations
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 |
|---|---|---|
| Baby oilAlso: unscented liquid paraffinpatient in study 1, arm B washed unscented liquid paraffin (baby oil) in place of aqueous cream | Other | study 1: aqueous cream and baby oil |
| petroleum jellypatients in this arm, use petroleum jelly (vaseline), replacing emulsifying ointment as a moisturiser | Other | study 2: emulsifying ointment and cetomacrogol |
| Glycerine:petroleum jelly 2:1patients in this arm use glycerine and petroleum jelly mixed at a ratio of 2:1 in place of cetomacrogol as a moisturiser | Other | study 2: emulsifying ointment and cetomacrogol |
Primary outcome
Change in the validated SCORing Atopic Dermatitis(SCORAD)
Time frame: Baseline, week 4, 8 and week 12
Change in the validated SCORing Atopic Dermatitis(SCORAD) and two other validated clinical scores (Nottingham Atopic Eczema Severity Score(NESS) and Patient Oriented Eczema Measure(POEM) were used to measure the extent/severity of AD. A validated quality-of-life form using the infants dermatitis quality of life (IDQOL) scale was completed by each care-giver at each visit.
1 secondary outcome
Change in the patient quality-of-life as measured by the infants dermatitis quality of life (IDQOL) index at each visit.
Time frame: Baseline, week 4, 8,12
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 12 Mar 2014.
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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.
Nonhlanhla Khumalo, MD, PhD study director
University of Cape Town
Carol Hlela, MD, PhD principal investigator
Red Cross War Memorial Childrens Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baby oil, petroleum jelly and Glycerine:petroleum jelly 2:1 in people with Childhood Atopic Dermatitis, run by Red Cross War Memorial Childrens Hospital at 1 site in South Africa.
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 2 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 12 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. 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?
Change in the validated SCORing Atopic Dermatitis(SCORAD) (time frame: Baseline, week 4, 8 and week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Mar 2014.