Soothing and Barrier Restoration Activity of a Body Cream for Atopic Skin

Atopic Dermatitis Clinical Trial

Official title:

Soothing and Barrier Restoration Activity of a Body Cream for Atopic Skin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03484897
• Other study ID #: E2117
• Status: Completed
• Phase: N/A
• First received: March 26, 2018
• Last updated: March 26, 2018
• Start date: January 12, 2018
• Est. completion date: March 20, 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 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 22 adult volunteers, with positive anamnesis for atopy and habitual itching.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: March 20, 2018
• Est. primary completion date: March 20, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Other:
• P927 - LICHTENA DermAD CREMA CORPO
The study cream was applied once a day (at the morning or at the evening), preferentially always at the same hour, with a mild massage, for an uninterrupted period of 1 month

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 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 month (T1), 2 months (T2)
Primary	Change from baseline of Superficial skin hydration	Skin electrical capacitance value is measured with Corneometer CM825	Baseline (T0), 1 month (T1), 2 months (T2)
Primary	Change from baseline of Deep skin hydration	Tissue dielectric constant of deep skin layers is measured with MoistureMeterD	Baseline (T0), 1 month (T1), 2 months (T2)
Primary	Change from baseline of Epicutaneous pH	Surface cutaneous pH is measured with pH meter HI5221	Baseline (T0), 1 month (T1), 2 months (T2)
Primary	Change from baseline of Surface microrelief's regularity	Surface microrelief's regularity is performed on skin replicas images acquired by Primos	Baseline (T0), 1 month (T1), 2 months (T2)
Secondary	Change from baseline of itching sensation	Each volunteers scored its own itching sensation thanks to a visual analogic scale (VAS from 0 = no itching to 10= strong itching).	Baseline (T0), 1 month (T1), 2 months (T2)