Atopic DermatitisNCT04728269
Exploratory Study on Lactibiane Topic AD on Skin Flora and Barrier Reinforcement in Mild to Moderate Atopic Dermatitis
A study testing Lactibiane Topic AD in people with Atopic Dermatitis, run by PiLeJe at 1 site in France.
Trial summary
This exploratory study aims to evaluate the impact of a cosmetic product (Lactibiane Topic AD) vs placebo on skin flora and skin reinforcement barrier in mild to moderate atopic dermatitis using biometrological, biological and clinical parameters. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Lactibiane Topic AD
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 19 Aug 2020to 9 Dec 2020
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject diagnosed with mild to moderate AD defined as SCORAD≤40 (Eichenfield et al. JAAD 2014).
- Subject with at least two symmetric AD lesions with comparable severity: Located either on upper extremities (left and right arms except hands) or lower extremities (left and right legs except feet), With an erythema ≥ 1 (mild to severe intensity), With a lesional area score ≥ 4 on both lesions with an authorized delta of two points between the two lesions, With a sufficient extent to allow all the investigations.
- Subject with I, II, III or IV skin phototype (according to Fitzpatrick's scale).
- For woman of childbearing potential (defined as all women physiologically capable of becoming pregnant): Negative urine pregnancy test at inclusion visit. Use of a highly effective method of birth control* during the study. * A highly effective method of birth control is defined as one which results in a low failure rate (less than 1%) when used consistently and correctly, such as implants, combined oral contraceptives, intrauterine device, double barrier methods (e.g. condom with spermicide), sexual abstinence or vasectomized partner.
- Subject with health insurance coverage according to local regulation.
- Subject having given his written informed consent.
Who cannot join
- Subject having a known hypersensitivity, allergy or contraindication to any ingredients contained within the investigational product or placebo.
- Subject having exposed his skin to natural or artificial UV within 8 weeks prior to the inclusion visit or intending to expose his skin during the study.
- Subject having performed phototherapy within 8 weeks prior to the inclusion visit or intending to perform phototherapy during the study.
- Subject having performed another physical treatment (e.g radiotherapy…) on the investigational areas within 6 months prior to the inclusion visit or intending to perform it during the study.
- Subject treated with systemic non-steroidal anti-inflammatory drugs (≥3 days) within 1 week before the inclusion visit.
- Subject treated with biological immunosuppressive drugs within 12 weeks prior to the inclusion visit or intending to be treated with it during the study.
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- Subject treated with non-biological immunosuppressive drugs within 4 weeks prior to the inclusion visit or intending to be treated with it during the study.
- Subject treated with systemic corticoids within 1 week prior to the inclusion visit or planed during the study.
- Subject treated with systemic antibiotics within 7 days prior to the inclusion visit or planed during the study.
- Subject having applied topical immunomodulators, non-steroidal anti-inflammatory, corticoids or antihistamines on investigational limbs within 1 weeks prior to the inclusion visit.
- Subject having applied topical antibiotics or disinfectants on investigational limbs within 2 weeks prior to the inclusion visit.
- Subject having applied any other topical and/or care product after the last grooming prior to the inclusion visit.
- Subject having applied water or care product (except hands cleaning) within 12 hours prior to the inclusion visit.
- Subject having started, modified or stopped any other treatment/product within 4 weeks prior to the inclusion visit or intending to do so during the study that according to the investigator's judgment, could interfere with study results.
- Subject having significant medical condition that according to the investigator's judgment, deems inappropriate for study participation (e.g present or past malignancy, present or past skin condition…).
- Subject having significant dermatological condition or sign (e.g disease, scare, abundant hairiness, tanning mark…) that according to the investigator's judgment, could limit the observations or/and interfere with the interpretations.
- Subject taking part or having participated in another clinical study within 2 weeks prior to the inclusion visit.
- Subject under legal guardianship or incapacitation.
- Subject linguistically or psychologically unable of signing informed consent form and unable to comply with the protocol requirements according to the investigator's judgment.
Trial locations and contacts
1 site in 1 country.
France1 site
Unité de Recherche Clinique en Immunologie - Lyon Sud
Pierre-Bénite, 69495
About this study
Official title: Exploratory Study to Assess the Impact of a Cosmetic Product (Lactibiane Topic AD) on Skin Flora and Skin Reinforcement Barrier in Mild to Moderate Atopic Dermatitis
This exploratory study aims to evaluate the impact of a cosmetic product (Lactibiane Topic AD) vs placebo on skin flora and skin reinforcement barrier in mild to moderate atopic dermatitis using biometrological, biological and clinical parameters.
- Conditions
- Atopic Dermatitis
- Being tested
- Lactibiane Topic AD, Placebo
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactibiane Topic ADOther
Application of Lactibiane topic AD twice a day (morning and evening) on one lesional area
PlaceboOther
Application of placebo twice a day (morning and evening) on the symmetrical lesional area
| Study group | Role | What they receive |
|---|---|---|
| Lactibiane topic AD | Experimental | Cosmetical product Lactibiane Topic AD Receives: Other: Lactibiane Topic AD |
| Placebo | Placebo comparator | Placebo made with the same base as the cosmetical product Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in skin flora composition
16S rRNA sequencing, qPCR
Measured: from baseline (Day 0) at Day 21
Change in skin flora composition
16S rRNA sequencing, qPCR
Measured: from baseline (Day 0) at Day 14
Secondary outcomes (5)
Skin barrier status
TransEpidermal Water Loss (TEWL)
Measured: Day 0, Day 14, Day 21
Patient Oriented SCORing Atopic Dermatitis
Patient Oriented SCORing Atopic Dermatitis (POSCORAD): 0 - 103 (Higher values represent a worse outcome)
Measured: Day 0, Day 14, Day 21
SCORing Atopic Dermatitis
SCORing Atopic Dermatitis (SCORAD) : 0 - 103 (Higher values represent a worse outcome)
Measured: Day 0, Day 14, Day 21
Clinical severity of lesional areas
Scoring of lesional area by subject and investigator : 0-18 (Higher values represent a worse outcome)
Measured: Day 0, Day 14, Day 21
Manifestation of adverse local reactions
Subjects will use a diary to document any potential adverse reactions observed after product application
Measured: From Day 0 to Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2021
- Study start19 Aug 2020
- Primary completion9 Dec 2020
- Study completion9 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- PiLeJe
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04728269
- Sponsor's protocol ID
- DEABIOM
- Status last verified
- Jan 2021
- First submitted
- 14 Jan 2021
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study to Assess the Impact of a Cosmetic Product (Lactibiane Topic AD) on Skin Flora and Skin Reinforcement Barrier in Mild to Moderate Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT04728269
- Acronym / sponsor ID
- DEABIOM
- Conditions
- Atopic Dermatitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- PiLeJeIndustry (pharma, biotech, devices)
- Study start
- 19 Aug 2020 (actual)
- Primary completion
- 9 Dec 2020 (actual)
- Study completion
- 9 Dec 2020 (actual)
- First posted
- 28 Jan 2021 (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.
This exploratory study aims to evaluate the impact of a cosmetic product (Lactibiane Topic AD) vs placebo on skin flora and skin reinforcement barrier in mild to moderate atopic dermatitis using biometrological, biological and clinical parameters.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactibiane topic AD | Experimental | Other: Lactibiane Topic ADCosmetical product Lactibiane Topic AD |
| Placebo | Placebo comparator | Other: PlaceboPlacebo made with the same base as the cosmetical product |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject diagnosed with mild to moderate AD defined as SCORAD≤40 (Eichenfield et al. JAAD 2014).
- Subject with at least two symmetric AD lesions with comparable severity: Located either on upper extremities (left and right arms except hands) or lower extremities (left and right legs except feet), With an erythema ≥ 1 (mild to severe intensity), With a lesional area score ≥ 4 on both lesions with an authorized delta of two points between the two lesions, With a sufficient extent to allow all the investigations.
- Subject with I, II, III or IV skin phototype (according to Fitzpatrick's scale).
- For woman of childbearing potential (defined as all women physiologically capable of becoming pregnant): Negative urine pregnancy test at inclusion visit. Use of a highly effective method of birth control* during the study. * A highly effective method of birth control is defined as one which results in a low failure rate (less than 1%) when used consistently and correctly, such as implants, combined oral contraceptives, intrauterine device, double barrier methods (e.g. condom with spermicide), sexual abstinence or vasectomized partner.
- Subject with health insurance coverage according to local regulation.
Key exclusion criteria (19 listed)
- Subject having a known hypersensitivity, allergy or contraindication to any ingredients contained within the investigational product or placebo.
- Subject having exposed his skin to natural or artificial UV within 8 weeks prior to the inclusion visit or intending to expose his skin during the study.
- Subject having performed phototherapy within 8 weeks prior to the inclusion visit or intending to perform phototherapy during the study.
- Subject having performed another physical treatment (e.g radiotherapy…) on the investigational areas within 6 months prior to the inclusion visit or intending to perform it during the study.
- Subject treated with systemic non-steroidal anti-inflammatory drugs (≥3 days) within 1 week before the inclusion visit.
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 |
|---|---|---|
| Lactibiane Topic ADApplication of Lactibiane topic AD twice a day (morning and evening) on one lesional area | Other | Lactibiane topic AD |
| PlaceboApplication of placebo twice a day (morning and evening) on the symmetrical lesional area | Other | Placebo |
Primary outcome
Change in skin flora composition
Time frame: from baseline (Day 0) at Day 21
16S rRNA sequencing, qPCR
Change in skin flora composition
Time frame: from baseline (Day 0) at Day 14
16S rRNA sequencing, qPCR
5 secondary outcomes
Skin barrier status
Time frame: Day 0, Day 14, Day 21
Patient Oriented SCORing Atopic Dermatitis
Time frame: Day 0, Day 14, Day 21
SCORing Atopic Dermatitis
Time frame: Day 0, Day 14, Day 21
Clinical severity of lesional areas
Time frame: Day 0, Day 14, Day 21
Manifestation of adverse local reactions
Time frame: From Day 0 to Day 21
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 2 Feb 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactibiane Topic AD in people with Atopic Dermatitis, run by PiLeJe at 1 site in France.
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 6 inclusion and 19 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 2 Feb 2021. 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 France. 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. Some participants in this study may receive a placebo. 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 skin flora composition (time frame: from baseline (Day 0) at Day 21). The study lists 2 primary outcomes in all. 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 2 Feb 2021.