Atopic DermatitisNCT03484897
Soothing and Barrier Restoration Activity of a Body Cream for Atopic Skin
A study testing P927 - LICHTENA DermAD CREMA CORPO in people with Atopic Dermatitis, run by Derming SRL at 1 site in Italy.
Trial summary
Open clinical study to evaluate the soothing activity of a body cream to be applied once a day, mono-laterally at level of the antecubital fold and forearm, for an uninterrupted period of 1 month, by 22 adult volunteers, with positive anamnesis for atopy and habitual itching. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- P927 - LICHTENA DermAD CREMA CORPO
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteItaly
- Study dates
- 12 Jan 2018to 20 Mar 2018
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult volunteers of both sexes
- volunteers with positive anamnesis for atopy and habitual itching
- volunteers in a good general state of health in the Investigator opinion
- negative pregnancy test (only for female subjects not in menopause)
- accepting to follow the instructions received by the investigator
- accepting to not change their habits regarding food, physical activity, body cleansing
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- agreeing not to apply or take any product/drug or use body massages able to change skin conditions during the entire duration of the study
- accepting not to expose their face to strong UV irradiation (UV session, or sun bathes), during the entire duration of the study
- no participation in a similar study currently or during the previous 3 months
- volunteers who are giving a written informed consent.
Who cannot join
- Pregnancy (only for female subjects not in menopause)
- lactation (only for female subjects not in menopause)
- change in the normal habits in the last month
- participation in a similar study during the previous 3 months
- known allergy to one or several ingredients of the product on trial
- insufficient adhesion to the study protocol
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- Dermatitis
- presence of cutaneous disease on the tested area, as lesions, scars, malformations
- clinical and significant skin condition on the test area.
- Diabetes
- endocrine disease
- hepatic disorder
- renal disorder
- cardiac disorder
- pulmonary disease
- cancer
- neurological or psychological disease
- inflammatory/immunosuppressive disease
- drug allergy.
- Anti-histaminic, topic and systemic corticosteroids, narcotic, antidepressant, immunosuppressive drugs (with the except of contraceptive or hormonal treatment starting more than 1 year ago)
- using of drugs able to influence the test results in the investigator opinion.
Trial locations and contacts
1 site in 1 country.
About this study
Open clinical study to evaluate the soothing activity of a body cream to be applied once a day, mono-laterally at level of the antecubital fold and forearm, for an uninterrupted period of 1 month, by 22 adult volunteers, with positive anamnesis for atopy and habitual itching.
- Conditions
- Atopic Dermatitis
- Being tested
- P927 - LICHTENA DermAD CREMA CORPO
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P927 - LICHTENA DermAD CREMA CORPOOther
The study cream was applied once a day (at the morning or at the evening), preferentially always at the same hour, with a mild massage, for an uninterrupted period of 1 month
| Study group | Role | What they receive |
|---|---|---|
| P927 - LICHTENA DermAD CREMA CORPO | Experimental | Application of the product under study mono-laterally at level of the forearm, including the antecubital fold, on the right or left side according to a randomization list defined by the investigator. Receives: Other: P927 - LICHTENA DermAD CREMA CORPO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of Transepidermal water loss (TEWL)
The measurement of TEWL, performed by the use of Tewameter® TM300, allows to objectively monitor skin responses to cosmetic treatments. A shift from low-normal rates of TEWL to high levels is due to barrier disruption.
Measured: Baseline (T0), 1 month (T1), 2 months (T2)
Change from baseline of Superficial skin hydration
Skin electrical capacitance value is measured with Corneometer CM825
Measured: Baseline (T0), 1 month (T1), 2 months (T2)
Change from baseline of Deep skin hydration
Tissue dielectric constant of deep skin layers is measured with MoistureMeterD
Measured: Baseline (T0), 1 month (T1), 2 months (T2)
Change from baseline of Epicutaneous pH
Surface cutaneous pH is measured with pH meter HI5221
Measured: Baseline (T0), 1 month (T1), 2 months (T2)
Change from baseline of Surface microrelief's regularity
Surface microrelief's regularity is performed on skin replicas images acquired by Primos
Measured: Baseline (T0), 1 month (T1), 2 months (T2)
Secondary outcomes (1)
Change from baseline of itching sensation
Each volunteers scored its own itching sensation thanks to a visual analogic scale (VAS from 0 = no itching to 10= strong itching).
Measured: Baseline (T0), 1 month (T1), 2 months (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2018
- Study start12 Jan 2018
- Primary completion20 Mar 2018
- Study completion20 Mar 2018
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Derming SRL
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adele Sparavigna, Derming SRL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03484897
- Sponsor's protocol ID
- E2117
- Status last verified
- Mar 2018
- First submitted
- 26 Mar 2018
- Last updated
- 2 Apr 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Soothing and Barrier Restoration Activity of a Body Cream for Atopic Skin
- ClinicalTrials.gov ID
- NCT03484897
- Acronym / sponsor ID
- E2117
- Conditions
- Atopic Dermatitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Derming SRLUniversity, hospital or other
- Study start
- 12 Jan 2018 (actual)
- Primary completion
- 20 Mar 2018 (actual)
- Study completion
- 20 Mar 2018 (actual)
- First posted
- 2 Apr 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.
Open clinical study to evaluate the soothing activity of a body cream to be applied once a day, mono-laterally at level of the antecubital fold and forearm, for an uninterrupted period of 1 month, by 22 adult volunteers, with positive anamnesis for atopy and habitual itching.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| P927 - LICHTENA DermAD CREMA CORPO | Experimental | Other: P927 - LICHTENA DermAD CREMA CORPOApplication of the product under study mono-laterally at level of the forearm, including the antecubital fold, on the right or left side according to a randomization list defined by the investigator. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Adult volunteers of both sexes
- volunteers with positive anamnesis for atopy and habitual itching
- volunteers in a good general state of health in the Investigator opinion
- negative pregnancy test (only for female subjects not in menopause)
- accepting to follow the instructions received by the investigator
Key exclusion criteria (21 listed)
- Pregnancy (only for female subjects not in menopause)
- lactation (only for female subjects not in menopause)
- change in the normal habits in the last month
- participation in a similar study during the previous 3 months
- known allergy to one or several ingredients of the product on trial
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 |
|---|---|---|
| P927 - LICHTENA DermAD CREMA CORPOThe study cream was applied once a day (at the morning or at the evening), preferentially always at the same hour, with a mild massage, for an uninterrupted period of 1 month | Other | P927 - LICHTENA DermAD CREMA CORPO |
Primary outcome
Change from baseline of Transepidermal water loss (TEWL)
Time frame: Baseline (T0), 1 month (T1), 2 months (T2)
The measurement of TEWL, performed by the use of Tewameter® TM300, allows to objectively monitor skin responses to cosmetic treatments. A shift from low-normal rates of TEWL to high levels is due to barrier disruption.
Change from baseline of Superficial skin hydration
Time frame: Baseline (T0), 1 month (T1), 2 months (T2)
Skin electrical capacitance value is measured with Corneometer CM825
Change from baseline of Deep skin hydration
Time frame: Baseline (T0), 1 month (T1), 2 months (T2)
Tissue dielectric constant of deep skin layers is measured with MoistureMeterD
Change from baseline of Epicutaneous pH
Time frame: Baseline (T0), 1 month (T1), 2 months (T2)
Surface cutaneous pH is measured with pH meter HI5221
Change from baseline of Surface microrelief's regularity
Time frame: Baseline (T0), 1 month (T1), 2 months (T2)
Surface microrelief's regularity is performed on skin replicas images acquired by Primos
1 secondary outcome
Change from baseline of itching sensation
Time frame: Baseline (T0), 1 month (T1), 2 months (T2)
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 Apr 2018.
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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 P927 - LICHTENA DermAD CREMA CORPO in people with Atopic Dermatitis, run by Derming SRL at 1 site in Italy.
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 10 inclusion and 21 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 Apr 2018. 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 Italy. 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 from baseline of Transepidermal water loss (TEWL) (time frame: Baseline (T0), 1 month (T1), 2 months (T2)). The study lists 5 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 Apr 2018.