Status:
COMPLETED
Soothing and Barrier Restoration Activity of a Body Cream for Atopic Skin
Lead Sponsor:
Derming SRL
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 20 2018
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT03484897
Start Date
January 12 2018
End Date
March 20 2018
Last Update
April 2 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
DERMING
Milan, MI, Italy, 20149