Soothing and Barrier Restoration Activity of a Body Cream for Atopic Skin
- Conditions
- Atopic Dermatitis
- Interventions
- Other: P927 - LICHTENA DermAD CREMA CORPO
- Registration Number
- NCT03484897
- Lead Sponsor
- Derming SRL
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 22
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description P927 - LICHTENA DermAD CREMA CORPO P927 - LICHTENA DermAD CREMA CORPO 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.
- Primary Outcome Measures
Name Time Method 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 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
Change from baseline of Epicutaneous pH Baseline (T0), 1 month (T1), 2 months (T2) Surface cutaneous pH is measured with pH meter HI5221
- Secondary Outcome Measures
Name Time Method 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).
Trial Locations
- Locations (1)
DERMING
🇮🇹Milano, MI, Italy