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

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.

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Other: P927 - LICHTENA DermAD CREMA CORPO

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • MI
    • Milano, MI, Italy, 20149
      • DERMING

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: P927 - LICHTENA DermAD CREMA CORPO; Application of the product under study mono-laterally at level of the forearm, including the antecubital fold, on the right or left side according to a randomization list defined by the investigator.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
Change from baseline of Superficial skin hydration	Skin electrical capacitance value is measured with Corneometer CM825	Baseline (T0), 1 month (T1), 2 months (T2)
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)
Change from baseline of Epicutaneous pH	Surface cutaneous pH is measured with pH meter HI5221	Baseline (T0), 1 month (T1), 2 months (T2)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Derming SRL

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 12, 2018
• Primary Completion (ACTUAL): March 20, 2018
• Study Completion (ACTUAL): March 20, 2018

Study Registration Dates

• First Submitted: March 26, 2018
• First Submitted That Met QC Criteria: March 26, 2018
• First Posted (ACTUAL): April 2, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 2, 2018
• Last Update Submitted That Met QC Criteria: March 26, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Dermatitis
• Other Study ID Numbers: E2117

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No