Soothing and Re-epithelizing Activity of New Cosmetic Formulations in Comparison to Placebo and Untreated Control Area

Sensitive Skin Clinical Trial

Official title:

Soothing and Re-epithelizing Activity of New Cosmetic Formulations in Comparison to Placebo and Untreated Control Area

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03464890
• Other study ID #: E2017
• Status: Completed
• Phase: N/A
• First received: March 8, 2018
• Last updated: March 26, 2018
• Start date: January 22, 2018
• Est. completion date: February 13, 2018

Study information

• Verified date: March 2018
• Source: Derming SRL
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Sensitive Skin

Intervention

Other:
• P926 - LICHTENA DermAD CREMA VISO
The study product was applied on a skin areas of about 14 cm2 of the forearm, defined turning on the right and left side in accordance with a randomization list, on which an erythema has been experimentally induced by repeated tape stripping.
• P927 - LICHTENA DermAD CREMA CORPO
The study product was applied on a skin areas of about 14 cm2 of the forearm, defined turning on the right and left side in accordance with a randomization list, on which an erythema has been experimentally induced by repeated tape stripping.
• P926 - LICHTENA DermAD CREMA VISO - PLACEBO
The study product was applied on a skin areas of about 14 cm2 of the forearm, defined turning on the right and left side in accordance with a randomization list, on which an erythema has been experimentally induced by repeated tape stripping.
• Untreated control area
Untreated skin area of about 14 cm2 of the forearm, defined turning on the right and left side in accordance with a randomization list, on which an erythema has been experimentally induced by repeated tape stripping.

Locations

Country	Name	City	State
Italy	DERMING	Milano	MI

Sponsors (1)

Lead Sponsor	Collaborator
Derming SRL

Country where clinical trial is conducted

Italy, 

Outcome

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)