Sensitive Skin Clinical Trial
Official title:
Soothing and Re-epithelizing Activity of New Cosmetic Formulations in Comparison to Placebo and Untreated Control Area
Verified date | March 2018 |
Source | Derming SRL |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | February 13, 2018 |
Est. primary completion date | February 13, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Italy | DERMING | Milano | MI |
Lead Sponsor | Collaborator |
---|---|
Derming SRL |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline of skin erythema index | The instrumental measurement of erythema is performed by the use of an optical densitometer (X-RITE 404) | Baseline (T0), 1 hour (T1h), 24 hours (T24h) | |
Primary | Change from baseline of skin redness | The instrumental measurement of skin redness is performed by the use of an optical colorimetry (Chroma Meter CR-200®) | Baseline (T0), 1 hour (T1h), 24 hours (T24h) | |
Primary | Change from baseline of Transepidermal water loss (TEWL) | 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. | Baseline (T0), 1 hour (T1h), 24 hours (T24h) | |
Primary | Change from baseline of Superficial skin hydration | Skin electrical capacitance value is measured with Corneometer CM825 | Baseline (T0), 1 hour (T1h), 24 hours (T24h) | |
Primary | Change from baseline of deep skin hydration | Tissue dielectric constant of deep skin layers is measured with MoistureMeterD | Baseline (T0), 1 hour (T1h), 24 hours (T24h) | |
Primary | Change from baseline of Epicutaneous pH | Surface cutaneous pH is measured with pH meter HI5221 | Baseline (T0), 1 hour (T1h), 24 hours (T24h) | |
Primary | Change from baseline of Surface microrelief's regularity | Surface microrelief's regularity is performed on skin replicas images acquired by Primos compact portable | Baseline (T0), 1 hour (T1h), 24 hours (T24h) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05094700 -
A Study of a Polymeric Surfactant Technology Cleanser in Sensitive Skin Participants
|
N/A | |
Enrolling by invitation |
NCT01871883 -
TRPV Expression in Subjects With Sensitive Skin
|
Phase 4 | |
Active, not recruiting |
NCT04898582 -
Clinical Benefit of M89PB in Subjects With Rosacea Associated With Erythema and Sensitive Skin
|
N/A | |
Completed |
NCT03279003 -
Study of the Efficacy and Tolerance of Light Therapy in Sensitive Skin
|
N/A | |
Completed |
NCT05630027 -
A Scalp Lotion Toimprove Sensitive Scalp Syndrome
|
||
Completed |
NCT03958968 -
Impact of Exposure to Cosmetics on Sensitive Skin
|
||
Completed |
NCT03081403 -
Quantitative Sensory Testing in Subjects With Sensitive Skin or Not
|
N/A |