Status:
COMPLETED
Soothing and Re-epithelizing Activity of New Cosmetic Formulations in Comparison to Placebo and Untreated Control Area
Lead Sponsor:
Derming SRL
Conditions:
Sensitive Skin
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Open clinical study to evaluate the soothing and re-epithelizing activity of a single application of two cometic formulations ("P926 - LICHTENA DermAD CREMA VISO" and "P927 - LICHTENA DermAD CREMA COR...
Eligibility Criteria
Inclusion
- Volunteers of both sexes
- TEWL value on tested skin areas immediately after tape stripping \>15g/m2-h
- volunteers in a good general state of health in the Investigator opinion
- volunteers not taking drugs or undergoing surgical procedure
- volunteers who are giving a written informed consent.
Exclusion
- Pregnancy (only for female subjects)
- lactation (only for female subjects)
- TEWL value on tested skin areas immediately after tape stripping \<15g/m2-h
- change in the normal habits in the last month
- participation in a similar study during the previous month
- known allergy to one or several ingredients of the products on trial.
- 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 22 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 13 2018
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03464890
Start Date
January 22 2018
End Date
February 13 2018
Last Update
March 27 2018
Active Locations (1)
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1
DERMING
Milan, MI, Italy, 20149