Dry and Damaged SkinNCT03279159
Hydrating Efficacy and Tolerance Evaluation of a Face Cream
A study testing Jaluronius CS cream short term evaluation and Jaluronius CS cream long term evaluation in people with Dry and Damaged Skin, run by Derming SRL at 1 site in Italy.
Trial summary
Aim of the study was to evaluate by non-invasive instrumental evaluations tolerance and hydrating activity of a face topic product, to be applied twice a day, morning and evening, for an uninterrupted period of 8 weeks, by volunteers of both sexes, aged 45-60, who meet the inclusion and exclusion criteria required by… Read more about this study
- Who is it for?
- Ages 45 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry and Damaged Skin
- What is being tested?
- Jaluronius CS cream short term evaluation and Jaluronius CS cream long term evaluation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteItaly
- Study dates
- 22 Mar 2017to 25 May 2017
- 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 45 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- both sexes,
- age 45-60 years,
- caucasian subjects,
- agreeing to present at each study visit without make-up,
- accepting to follow the instructions received by the investigator,
- accepting to not change their habits regarding food, physical activity, face cleansing and make- up use,
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- agreeing not to apply or take any product or use face massages or other means known to improve skin wrinkle and skin qualities 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
- accepting to sign the Informed consent form.
Who cannot join
- Pregnancy (only for female subjects),
- lactation (only for female subjects),
- sensitivity to the test product or its ingredients (to be assessed by the investigator during the baseline visit),
- subjects whose insufficient adhesion to the study protocol is foreseeable.
- presence of cutaneous disease on the tested area as lesions, scars, malformations,
- recurrent facial/labial herpes,
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- clinical and significant skin condition on the test area (e.g. active eczema, dermatitis, psoriasis etc.).
- endocrine disease,
- hepatic disorder,
- renal disorder,
- cardiac disorder,
- pulmonary disease,
- cancer,
- neurological or psychological disease,
- inflammatory/immunosuppressive disease,
- drug allergy.
- anti-inflammatory drugs, anti-histaminic, topic (application on the face) and systemic corticosteroids, narcotic, antidepressant, immunosuppressive drugs (with the except of hormonal treatment starting more than 1 year ago),
- using of drugs or dietary supplements able to influence the test results in the investigator opinion.
Trial locations and contacts
1 site in 1 country.
About this study
Aim of the study was to evaluate by non-invasive instrumental evaluations tolerance and hydrating activity of a face topic product, to be applied twice a day, morning and evening, for an uninterrupted period of 8 weeks, by volunteers of both sexes, aged 45-60, who meet the inclusion and exclusion criteria required by the study procedure .
It was also aim of this study to evaluate the hydrating activity of a single product application on the skin damaged by repeated stripping corneum (short term evaluation versus untreated control area).
- Conditions
- Dry and Damaged Skin
- Being tested
- Jaluronius CS cream short term evaluation, Jaluronius CS cream long term evaluation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jaluronius CS cream short term evaluationOther
Short term evaluation to investigate the hydrating activity of a single application of the study product on the forearms (volar surface) after repeated stripping procedure,measured immediately after stripping execution (T0i), 1,8 and 24 hour/s after product application (T1h, T8h and T24h).
Jaluronius CS cream long term evaluationOther
Long term evaluation to investigate the hydrating activity of the repeated application of the study product on the face (twice a day, for an uninterrupted period of 8 weeks), measured at basal visit (T0) and after 4 and 8 week-treatment (T4, T8)
| Study group | Role | What they receive |
|---|---|---|
| Jaluronius CS cream (Difa Cooper S.p.a, Italy) | Experimental | Not described Receives: Other: Jaluronius CS cream short term evaluation; Other: Jaluronius CS cream long term evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of superficial skin hydration after a single product application
Variation of skin electrical capacitance value measured with Corneometer CM825 (Courage - Khazaka, Köln, Germany) after a single product application on the skin area damaged by corneum stripping
Measured: Immediately after stripping (T0i), 1 hour after product application (T1h), 8 hours after product application (T8h), 24 hours after product application (T24h)
Change of transepidermal water loss (TEWL) after a single product application
Variation of transepidermal water loss value measured with Tewameter® TM300 (MPA 5 Courage-Khazaka, Germany) after a single product application on the skin area damaged by corneum stripping
Measured: Immediately after stripping (T0i), 1 hour after product application (T1h), 8 hours after product application (T8h), 24 hours after product application (T24h)
Change of superficial skin hydration after repeated product application
Variation of skin electrical capacitance value measured with Corneometer CM825 (Courage - Khazaka, Köln, Germany) after repeated product application on the face
Measured: Baseline (T0), 4 weeks (T4), 8 weeks (T8)
Change of deep skin hydration after repeated product application
Variation of tissue dielectric constant value of deep skin layers measured with MoistureMeterD (Delfin Technologies, Kuopio - Finland) after repeated product application on the face
Measured: Baseline (T0), 4 weeks (T4), 8 weeks (T8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study start22 Mar 2017
- Primary completion25 May 2017
- Study completion25 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry and Damaged 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
- 18 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
- NCT03279159
- Sponsor's protocol ID
- E0617
- Status last verified
- Jun 2017
- First submitted
- 4 Sep 2017
- Last updated
- 12 Sep 2017
- 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 12 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hydrating Efficacy and Tolerance Evaluation of a Face Cream
- ClinicalTrials.gov ID
- NCT03279159
- Acronym / sponsor ID
- E0617
- Conditions
- Dry and Damaged Skin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Derming SRLUniversity, hospital or other
- Study start
- 22 Mar 2017 (actual)
- Primary completion
- 25 May 2017 (actual)
- Study completion
- 25 May 2017 (actual)
- First posted
- 12 Sep 2017 (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.
Aim of the study was to evaluate by non-invasive instrumental evaluations tolerance and hydrating activity of a face topic product, to be applied twice a day, morning and evening, for an uninterrupted period of 8 weeks, by volunteers of both sexes, aged 45-60, who meet the inclusion and exclusion criteria required by the study procedure .
It was also aim of this study to evaluate the hydrating activity of a single product application on the skin damaged by repeated stripping corneum (short term evaluation 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 |
|---|---|---|
| Jaluronius CS cream (Difa Cooper S.p.a, Italy) | Experimental | Other: Jaluronius CS cream short term evaluation, Other: Jaluronius CS cream long term evaluation |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- both sexes,
- age 45-60 years,
- caucasian subjects,
- agreeing to present at each study visit without make-up,
- accepting to follow the instructions received by the investigator,
Key exclusion criteria (18 listed)
- Pregnancy (only for female subjects),
- lactation (only for female subjects),
- sensitivity to the test product or its ingredients (to be assessed by the investigator during the baseline visit),
- subjects whose insufficient adhesion to the study protocol is foreseeable.
- presence of cutaneous disease on the tested area as lesions, scars, malformations,
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 |
|---|---|---|
| Jaluronius CS cream short term evaluationShort term evaluation to investigate the hydrating activity of a single application of the study product on the forearms (volar surface) after repeated stripping procedure,measured immediately after stripping execution (T0i), 1,8 and 24 hour/s after product application (T1h, T8h and T24h). | Other | Jaluronius CS cream (Difa Cooper S.p.a, Italy) |
| Jaluronius CS cream long term evaluationLong term evaluation to investigate the hydrating activity of the repeated application of the study product on the face (twice a day, for an uninterrupted period of 8 weeks), measured at basal visit (T0) and after 4 and 8 week-treatment (T4, T8) | Other | Jaluronius CS cream (Difa Cooper S.p.a, Italy) |
Primary outcome
Change of superficial skin hydration after a single product application
Time frame: Immediately after stripping (T0i), 1 hour after product application (T1h), 8 hours after product application (T8h), 24 hours after product application (T24h)
Variation of skin electrical capacitance value measured with Corneometer CM825 (Courage - Khazaka, Köln, Germany) after a single product application on the skin area damaged by corneum stripping
Change of transepidermal water loss (TEWL) after a single product application
Time frame: Immediately after stripping (T0i), 1 hour after product application (T1h), 8 hours after product application (T8h), 24 hours after product application (T24h)
Variation of transepidermal water loss value measured with Tewameter® TM300 (MPA 5 Courage-Khazaka, Germany) after a single product application on the skin area damaged by corneum stripping
Change of superficial skin hydration after repeated product application
Time frame: Baseline (T0), 4 weeks (T4), 8 weeks (T8)
Variation of skin electrical capacitance value measured with Corneometer CM825 (Courage - Khazaka, Köln, Germany) after repeated product application on the face
Change of deep skin hydration after repeated product application
Time frame: Baseline (T0), 4 weeks (T4), 8 weeks (T8)
Variation of tissue dielectric constant value of deep skin layers measured with MoistureMeterD (Delfin Technologies, Kuopio - Finland) after repeated product application on the face
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 Sep 2017.
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 Jaluronius CS cream short term evaluation and Jaluronius CS cream long term evaluation in people with Dry and Damaged 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 10 inclusion and 18 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 Sep 2017. 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 of superficial skin hydration after a single product application (time frame: Immediately after stripping (T0i), 1 hour after product application (T1h), 8 hours after product application (T8h), 24 hours after product application (T24h)). The study lists 4 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 12 Sep 2017.