Atopic DermatitisNCT03632174
Evaluation and Comparison of 2 Cosmetic Investigational Products in Adults With Atopic Dermatitis
A study testing Topical Ointment with L. reuteri and Topical Ointment without L. reuteri in people with Atopic Dermatitis, run by BioGaia AB at 1 site in South Africa.
Trial summary
The study consists in the application of 2 investigational products (one group per investigational product) under normal conditions of use, in adult participants with Atopic Dermatitis. It is carried out on cosmetic products, with the aim to further confirm safety of these products Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Topical Ointment with L. reuteri and Topical Ointment without L. reuteri
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSouth Africa
- Study dates
- 21 Jan 2019to 16 Oct 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant has not been on a course of long term treatment in particular with aspirin, products containing aspirin, anti-inflammatories, antibiotics, antihistamines, corticoids
- Participant presenting with mild to moderate atopic dermatitis according to the definition of the UK Working Party's Diagnostic Criteria for Atopic Dermatitis (SCORAD index >25)
- Participant presenting with a current lesion of Atopic Dermatitis on defined area
Who cannot join
- Participant is pregnant, breast feeding or not willing to take the necessary precautions to avoid pregnancy during the study
- Participant having background of intolerance or allergy
- Participant not respecting the washout period during which a person may not be involved in any other biomedical research projects
- Participant having skin exposed to sunlight within 2 weeks preceding the inclusion
- Participant having modified his/her cosmetic habits during the last two weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Study for the Evaluation and Comparison of Cutaneous Acceptability and the Efficacy of 2 Cosmetic Products, Under Normal Conditions of Use, in Adult Participants With Atopic Dermatitis
The study consists in the application of 2 investigational products (one group per investigational product) under normal conditions of use, in adult participants with Atopic Dermatitis.
It is carried out on cosmetic products, with the aim to further confirm safety of these products
Read the detailed description
Probiotics are live micro-organisms which when administered in adequate amounts can exert a health benefit on the host. This health-promoting effects of Lactobacillus reuteri have been extensively studied in the gastrointestinal tract but it is clear that other areas are also interesting for the use of probiotics.
Atopic Dermatitis is a relapsing inflammatory skin disease appearing on persons with a genetic predisposition of allergic pathology. AD generally starts in childhood, however in some cases can continue into adult hood, in at least 10% of cases. AD can effect a persons quality of life and in the chronic stage it can present with dry skin and lichenification.
Research has shown that probiotics have an antimicrobial, anti-inflammatory and barrier function effect, and could therefore be used on subjects with Atopic Dermatitis to relieve and protect.
- Conditions
- Atopic Dermatitis
- Being tested
- Topical Ointment with L. reuteri, Topical Ointment without L. reuteri
- Keywords
- Probiotic, Atopic Dermatitis, Lactobacillus reuteri
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical Ointment with L. reuteriOther
Also called Probiotic ointment A
Topical Ointment containing live Lactobacillus reuteri DSM17938 applied twice daily in dry areas of the entire body
Topical Ointment without L. reuteriOther
Also called Non Probiotic ointment B
Topical Ointment that does not contain Lactobacillus reuteri DSM17938 applied twice daily in dry areas of the entire body
| Study group | Role | What they receive |
|---|---|---|
| Topical Ointment with L. reuteri | Experimental | Adult subjects presenting with mild-moderate Atopic Dermatitis Receives: Other: Topical Ointment with L. reuteri |
| Topical Ointment without L. reuteri | Experimental | Adult subjects presenting with mild-moderate Atopic Dermatitis Receives: Other: Topical Ointment without L. reuteri |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appraisal of Cutaneous acceptability of the investigational products by dermatologist investigator
Cutaneous acceptability is assessed on the basis of clinical examination of the skin for physical signs (erythema, oedema, dryness) linked to the use of the investigational product and also evaluation the functional signs (prickling, tightness, heating)
Measured: 4 weeks
Secondary outcomes (2)
Change in SCORAD index over 8 week period
Clinical evaluation by the dermatologist investigator to assess change in skin conditions to each parameter of "SCORing Atopic Dermatitis" (SCORAD) (erythema, edema, xerosis) and participant symptoms: pruritus and sleep quality
Measured: baseline, at 4 and 8 weeks
Change in Local SCORAD index
Change evaluated by the dermatologist investigator at each visit, on the recurrent lesion (defined area) and control area selected at baseline
Measured: baseline, at 4, and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start21 Jan 2019
- Primary completion2 Sep 2019
- Study completion16 Oct 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 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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comparison of two cosmetic products
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioGaia AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Burgert Jaques Van Wyk, MB, ChB, Principal investigator, South African Medical Association
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03632174
- Sponsor's protocol ID
- CSUB0167
- Status last verified
- Oct 2019
- First submitted
- 1 Aug 2018
- Last updated
- 22 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rosenfeldt V, Benfeldt E, Nielsen SD, Michaelsen KF, Jeppesen DL, Valerius NH, Paerregaard A. Effect of probiotic Lactobacillus strains in children with atopic dermatitis. J Allergy Clin Immunol. 2003 Feb;111(2):389-95. doi: 10.1067/mai.2003.389.
PubMed 12589361
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study for the Evaluation and Comparison of Cutaneous Acceptability and the Efficacy of 2 Cosmetic Products, Under Normal Conditions of Use, in Adult Participants With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT03632174
- Acronym / sponsor ID
- CSUB0167
- Conditions
- Atopic Dermatitis
- Keywords
- Probiotic, Atopic Dermatitis, Lactobacillus reuteri
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- BioGaia ABIndustry (pharma, biotech, devices)
- Study start
- 21 Jan 2019 (actual)
- Primary completion
- 2 Sep 2019 (actual)
- Study completion
- 16 Oct 2019 (actual)
- First posted
- 15 Aug 2018 (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 consists in the application of 2 investigational products (one group per investigational product) under normal conditions of use, in adult participants with Atopic Dermatitis.
It is carried out on cosmetic products, with the aim to further confirm safety of these products
Detailed description
Probiotics are live micro-organisms which when administered in adequate amounts can exert a health benefit on the host. This health-promoting effects of Lactobacillus reuteri have been extensively studied in the gastrointestinal tract but it is clear that other areas are also interesting for the use of probiotics.
Atopic Dermatitis is a relapsing inflammatory skin disease appearing on persons with a genetic predisposition of allergic pathology. AD generally starts in childhood, however in some cases can continue into adult hood, in at least 10% of cases. AD can effect a persons quality of life and in the chronic stage it can present with dry skin and lichenification.
Research has shown that probiotics have an antimicrobial, anti-inflammatory and barrier function effect, and could therefore be used on subjects with Atopic Dermatitis to relieve and protect.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Comparison of two cosmetic products
| Arm | Type | Receives |
|---|---|---|
| Topical Ointment with L. reuteri | Experimental | Other: Topical Ointment with L. reuteriAdult subjects presenting with mild-moderate Atopic Dermatitis |
| Topical Ointment without L. reuteri | Experimental | Other: Topical Ointment without L. reuteriAdult subjects presenting with mild-moderate Atopic Dermatitis |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participant has not been on a course of long term treatment in particular with aspirin, products containing aspirin, anti-inflammatories, antibiotics, antihistamines, corticoids
- Participant presenting with mild to moderate atopic dermatitis according to the definition of the UK Working Party's Diagnostic Criteria for Atopic Dermatitis (SCORAD index >25)
- Participant presenting with a current lesion of Atopic Dermatitis on defined area
Key exclusion criteria (5 listed)
- Participant is pregnant, breast feeding or not willing to take the necessary precautions to avoid pregnancy during the study
- Participant having background of intolerance or allergy
- Participant not respecting the washout period during which a person may not be involved in any other biomedical research projects
- Participant having skin exposed to sunlight within 2 weeks preceding the inclusion
- Participant having modified his/her cosmetic habits during the last two weeks
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 |
|---|---|---|
| Topical Ointment with L. reuteriAlso: Probiotic ointment ATopical Ointment containing live Lactobacillus reuteri DSM17938 applied twice daily in dry areas of the entire body | Other | Topical Ointment with L. reuteri |
| Topical Ointment without L. reuteriAlso: Non Probiotic ointment BTopical Ointment that does not contain Lactobacillus reuteri DSM17938 applied twice daily in dry areas of the entire body | Other | Topical Ointment without L. reuteri |
Primary outcome
Appraisal of Cutaneous acceptability of the investigational products by dermatologist investigator
Time frame: 4 weeks
Cutaneous acceptability is assessed on the basis of clinical examination of the skin for physical signs (erythema, oedema, dryness) linked to the use of the investigational product and also evaluation the functional signs (prickling, tightness, heating)
2 secondary outcomes
Change in SCORAD index over 8 week period
Time frame: baseline, at 4 and 8 weeks
Change in Local SCORAD index
Time frame: baseline, at 4, and 8 weeks
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 22 Oct 2019.
- Background: PubMed 12589361Rosenfeldt V, Benfeldt E, Nielsen SD, Michaelsen KF, Jeppesen DL, Valerius NH, Paerregaard A. Effect of probiotic Lactobacillus strains in children with atopic dermatitis. J Allergy Clin Immunol. 2003 Feb;111(2):389-95. doi: 10.1067/mai.2003.389.
- Individual participant dataSharing planned: No
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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.
Burgert Jaques Van Wyk, MB, ChB principal investigator
South African Medical Association
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topical Ointment with L. reuteri and Topical Ointment without L. reuteri in people with Atopic Dermatitis, run by BioGaia AB 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 3 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 22 Oct 2019. 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?
Appraisal of Cutaneous acceptability of the investigational products by dermatologist investigator (time frame: 4 weeks). 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 NCT03632174, 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 22 Oct 2019.