Clinical trial NCT03464890: Soothing and Re-epithelizing Activity of New Cosmetic Formulations in Comparison to Placebo and Untreated Control Area
Official title: Soothing and Re-epithelizing Activity of New Cosmetic Formulations in Comparison to Placebo and Untreated Control Area
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sensitive Skin
Lead sponsor: Derming SRL
Sponsor class: OTHER
First posted: 2018-03-14
Enrollment: 20
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 and re-epithelizing activity of a single application of two cometic formulations ("P926 - LICHTENA DermAD CREMA VISO" and "P927 - LICHTENA DermAD CREMA CORPO") on experimentally induced erythema by repeated tape stripping on the forearm (volar surface) of 20 healthy volunteers.

Study products activity was assessed in comparison to placebo ("P926P - LICHTENA DermAD CREMA VISO - PLACEBO") and versus untreated control area.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Change from baseline of skin erythema index
timeFrame: Baseline (T0), 1 hour (T1h), 24 hours (T24h)
measure: Change from baseline of skin redness
timeFrame: Baseline (T0), 1 hour (T1h), 24 hours (T24h)
measure: Change from baseline of Transepidermal water loss (TEWL)
timeFrame: Baseline (T0), 1 hour (T1h), 24 hours (T24h)
measure: Change from baseline of Superficial skin hydration
timeFrame: Baseline (T0), 1 hour (T1h), 24 hours (T24h)
measure: Change from baseline of deep skin hydration
timeFrame: Baseline (T0), 1 hour (T1h), 24 hours (T24h)
measure: Change from baseline of Epicutaneous pH
timeFrame: Baseline (T0), 1 hour (T1h), 24 hours (T24h)
measure: Change from baseline of Surface microrelief's regularity
timeFrame: Baseline (T0), 1 hour (T1h), 24 hours (T24h)
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: DERMING
state: MI
Study officials:
References: