Atopic Dermatitis
Conditions
Brief 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.
Interventions
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
Sponsors
Derming SRL
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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 * 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.
Exclusion criteria
* 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 * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline of Transepidermal water loss (TEWL) | 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 | Baseline (T0), 1 month (T1), 2 months (T2) | Skin electrical capacitance value is measured with Corneometer CM825 |
| Change from baseline of Deep skin hydration | 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 | 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 | Baseline (T0), 1 month (T1), 2 months (T2) | Surface microrelief's regularity is performed on skin replicas images acquired by Primos |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline of itching sensation | Baseline (T0), 1 month (T1), 2 months (T2) | Each volunteers scored its own itching sensation thanks to a visual analogic scale (VAS from 0 = no itching to 10= strong itching). |
Countries
Italy
Outcome results
None listed