Sensitive SkinNCT03464890
Soothing and Re-epithelizing Activity of New Cosmetic Formulations in Comparison to Placebo and Untreated Control Area
A study testing P926 - LICHTENA DermAD CREMA VISO and P927 - LICHTENA DermAD CREMA CORPO in people with Sensitive Skin, run by Derming SRL at 1 site in Italy.
Trial summary
Open clinical study to evaluate the soothing and re-epithelizing activity of a single application of two cometic formulations ("P926 - LICHTENA DermAD CREMA VISO" and "P927 - LICHTENA DermAD CREMA CORPO") on experimentally induced erythema by repeated tape stripping on the forearm (volar surface) of 20 healthy… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sensitive Skin
- What is being tested?
- P926 - LICHTENA DermAD CREMA VISO and P927 - LICHTENA DermAD CREMA CORPO
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 22 Jan 2018to 13 Feb 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
- Volunteers of both sexes
- TEWL value on tested skin areas immediately after tape stripping >15g/m2-h
- volunteers in a good general state of health in the Investigator opinion
- volunteers not taking drugs or undergoing surgical procedure
- volunteers who are giving a written informed consent.
Who cannot join
- Pregnancy (only for female subjects)
- lactation (only for female subjects)
- TEWL value on tested skin areas immediately after tape stripping <15g/m2-h
- change in the normal habits in the last month
- participation in a similar study during the previous month
- known allergy to one or several ingredients of the products on trial.
Show all 21Show fewer
- 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 and re-epithelizing activity of a single application of two cometic formulations ("P926 - LICHTENA DermAD CREMA VISO" and "P927 - LICHTENA DermAD CREMA CORPO") on experimentally induced erythema by repeated tape stripping on the forearm (volar surface) of 20 healthy volunteers.
Study products activity was assessed in comparison to placebo ("P926P - LICHTENA DermAD CREMA VISO - PLACEBO") and versus untreated control area.
- Conditions
- Sensitive Skin
- Being tested
- P926 - LICHTENA DermAD CREMA VISO, P927 - LICHTENA DermAD CREMA CORPO, P926 - LICHTENA DermAD CREMA VISO - PLACEBO, Untreated control area
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P926 - LICHTENA DermAD CREMA VISOOther
The study product was applied on a skin areas of about 14 cm2 of the forearm, defined turning on the right and left side in accordance with a randomization list, on which an erythema has been experimentally induced by repeated tape stripping.
P927 - LICHTENA DermAD CREMA CORPOOther
The study product was applied on a skin areas of about 14 cm2 of the forearm, defined turning on the right and left side in accordance with a randomization list, on which an erythema has been experimentally induced by repeated tape stripping.
P926 - LICHTENA DermAD CREMA VISO - PLACEBOOther
The study product was applied on a skin areas of about 14 cm2 of the forearm, defined turning on the right and left side in accordance with a randomization list, on which an erythema has been experimentally induced by repeated tape stripping.
Untreated control areaOther
Untreated skin area of about 14 cm2 of the forearm, defined turning on the right and left side in accordance with a randomization list, on which an erythema has been experimentally induced by repeated tape stripping.
| Study group | Role | What they receive |
|---|---|---|
| LICHTENA DermAD | Experimental | Comparison within subjects of "P926 - LICHTENA DermAD CREMA VISO" and "P927 - LICHTENA DermAD CREMA CORPO" versus placebo and versus untreated control area. Study products were applied once, on experimentally induced erythema by repeated tape stripping on 4 different adjacent skin areas of the forearms (volar surface - 2 areas on each side) Receives: Other: P926 - LICHTENA DermAD CREMA VISO; Other: P927 - LICHTENA DermAD CREMA CORPO; Other: P926 - LICHTENA DermAD CREMA VISO - PLACEBO; Other: Untreated control area |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of skin erythema index
The instrumental measurement of erythema is performed by the use of an optical densitometer (X-RITE 404)
Measured: Baseline (T0), 1 hour (T1h), 24 hours (T24h)
Change from baseline of skin redness
The instrumental measurement of skin redness is performed by the use of an optical colorimetry (Chroma Meter CR-200®)
Measured: Baseline (T0), 1 hour (T1h), 24 hours (T24h)
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 hour (T1h), 24 hours (T24h)
Change from baseline of Superficial skin hydration
Skin electrical capacitance value is measured with Corneometer CM825
Measured: Baseline (T0), 1 hour (T1h), 24 hours (T24h)
Change from baseline of deep skin hydration
Tissue dielectric constant of deep skin layers is measured with MoistureMeterD
Measured: Baseline (T0), 1 hour (T1h), 24 hours (T24h)
Change from baseline of Epicutaneous pH
Surface cutaneous pH is measured with pH meter HI5221
Measured: Baseline (T0), 1 hour (T1h), 24 hours (T24h)
Change from baseline of Surface microrelief's regularity
Surface microrelief's regularity is performed on skin replicas images acquired by Primos compact portable
Measured: Baseline (T0), 1 hour (T1h), 24 hours (T24h)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2018
- Study start22 Jan 2018
- Primary completion13 Feb 2018
- Study completion13 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensitive SkinStudies 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
- 20 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
- NCT03464890
- Sponsor's protocol ID
- E2017
- Status last verified
- Mar 2018
- First submitted
- 8 Mar 2018
- Last updated
- 27 Mar 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 27 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Soothing and Re-epithelizing Activity of New Cosmetic Formulations in Comparison to Placebo and Untreated Control Area
- ClinicalTrials.gov ID
- NCT03464890
- Acronym / sponsor ID
- E2017
- Conditions
- Sensitive Skin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Derming SRLUniversity, hospital or other
- Study start
- 22 Jan 2018 (actual)
- Primary completion
- 13 Feb 2018 (actual)
- Study completion
- 13 Feb 2018 (actual)
- First posted
- 14 Mar 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 and re-epithelizing activity of a single application of two cometic formulations ("P926 - LICHTENA DermAD CREMA VISO" and "P927 - LICHTENA DermAD CREMA CORPO") on experimentally induced erythema by repeated tape stripping on the forearm (volar surface) of 20 healthy volunteers.
Study products activity was assessed in comparison to placebo ("P926P - LICHTENA DermAD CREMA VISO - PLACEBO") and versus untreated control area.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LICHTENA DermAD | Experimental | Other: P926 - LICHTENA DermAD CREMA VISO, Other: P927 - LICHTENA DermAD CREMA CORPO, Other: P926 - LICHTENA DermAD CREMA VISO - PLACEBO, Other: Untreated control areaComparison within subjects of "P926 - LICHTENA DermAD CREMA VISO" and "P927 - LICHTENA DermAD CREMA CORPO" versus placebo and versus untreated control area. Study products were applied once, on experimentally induced erythema by repeated tape stripping on 4 different adjacent skin areas of the forearms (volar surface - 2 areas on each side) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Volunteers of both sexes
- TEWL value on tested skin areas immediately after tape stripping >15g/m2-h
- volunteers in a good general state of health in the Investigator opinion
- volunteers not taking drugs or undergoing surgical procedure
- volunteers who are giving a written informed consent.
Key exclusion criteria (21 listed)
- Pregnancy (only for female subjects)
- lactation (only for female subjects)
- TEWL value on tested skin areas immediately after tape stripping <15g/m2-h
- change in the normal habits in the last month
- participation in a similar study during the previous month
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 |
|---|---|---|
| P926 - LICHTENA DermAD CREMA VISOThe study product was applied on a skin areas of about 14 cm2 of the forearm, defined turning on the right and left side in accordance with a randomization list, on which an erythema has been experimentally induced by repeated tape stripping. | Other | LICHTENA DermAD |
| P927 - LICHTENA DermAD CREMA CORPOThe study product was applied on a skin areas of about 14 cm2 of the forearm, defined turning on the right and left side in accordance with a randomization list, on which an erythema has been experimentally induced by repeated tape stripping. | Other | LICHTENA DermAD |
| P926 - LICHTENA DermAD CREMA VISO - PLACEBOThe study product was applied on a skin areas of about 14 cm2 of the forearm, defined turning on the right and left side in accordance with a randomization list, on which an erythema has been experimentally induced by repeated tape stripping. | Other | LICHTENA DermAD |
| Untreated control areaUntreated skin area of about 14 cm2 of the forearm, defined turning on the right and left side in accordance with a randomization list, on which an erythema has been experimentally induced by repeated tape stripping. | Other | LICHTENA DermAD |
Primary outcome
Change from baseline of skin erythema index
Time frame: Baseline (T0), 1 hour (T1h), 24 hours (T24h)
The instrumental measurement of erythema is performed by the use of an optical densitometer (X-RITE 404)
Change from baseline of skin redness
Time frame: Baseline (T0), 1 hour (T1h), 24 hours (T24h)
The instrumental measurement of skin redness is performed by the use of an optical colorimetry (Chroma Meter CR-200®)
Change from baseline of Transepidermal water loss (TEWL)
Time frame: Baseline (T0), 1 hour (T1h), 24 hours (T24h)
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 hour (T1h), 24 hours (T24h)
Skin electrical capacitance value is measured with Corneometer CM825
Change from baseline of deep skin hydration
Time frame: Baseline (T0), 1 hour (T1h), 24 hours (T24h)
Tissue dielectric constant of deep skin layers is measured with MoistureMeterD
Change from baseline of Epicutaneous pH
Time frame: Baseline (T0), 1 hour (T1h), 24 hours (T24h)
Surface cutaneous pH is measured with pH meter HI5221
Change from baseline of Surface microrelief's regularity
Time frame: Baseline (T0), 1 hour (T1h), 24 hours (T24h)
Surface microrelief's regularity is performed on skin replicas images acquired by Primos compact portable
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 27 Mar 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 P926 - LICHTENA DermAD CREMA VISO and P927 - LICHTENA DermAD CREMA CORPO in people with Sensitive Skin, 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 5 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 27 Mar 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 skin erythema index (time frame: Baseline (T0), 1 hour (T1h), 24 hours (T24h)). The study lists 7 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 27 Mar 2018.