Clinical trial NCT03484897: Soothing and Barrier Restoration Activity of a Body Cream for Atopic Skin
Official title: Soothing and Barrier Restoration Activity of a Body Cream for Atopic Skin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atopic Dermatitis
Lead sponsor: Derming SRL
Sponsor class: OTHER
First posted: 2018-04-02
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline of Transepidermal water loss (TEWL)
timeFrame: Baseline (T0), 1 month (T1), 2 months (T2)
measure: Change from baseline of Superficial skin hydration
timeFrame: Baseline (T0), 1 month (T1), 2 months (T2)
measure: Change from baseline of Deep skin hydration
timeFrame: Baseline (T0), 1 month (T1), 2 months (T2)
measure: Change from baseline of Epicutaneous pH
timeFrame: Baseline (T0), 1 month (T1), 2 months (T2)
measure: Change from baseline of Surface microrelief's regularity
timeFrame: Baseline (T0), 1 month (T1), 2 months (T2)
Secondary outcomes:
measure: Change from baseline of itching sensation
timeFrame: Baseline (T0), 1 month (T1), 2 months (T2)
Other outcomes:
Locations:
city: Milano
country: Italy
facility: DERMING
state: MI
Study officials:
References: