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

• ClinicalTrials.gov Identifier: NCT03484897
• Recruitment Status: Completed
• First Posted: April 2, 2018
• Last Update Posted: April 2, 2018
• Sponsor: Derming SRL
• Information provided by (Responsible Party): Adele Sparavigna, Derming SRL

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Atopic Dermatitis	Other: P927 - LICHTENA DermAD CREMA CORPO	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 22 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Soothing and Barrier Restoration Activity of a Body Cream for Atopic Skin
• Actual Study Start Date: January 12, 2018
• Actual Primary Completion Date: March 20, 2018
• Actual Study Completion Date: March 20, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Change from baseline of Transepidermal water loss (TEWL) [ Time Frame: Baseline (T0), 1 month (T1), 2 months (T2) ]
   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.
2. Change from baseline of Superficial skin hydration [ Time Frame: Baseline (T0), 1 month (T1), 2 months (T2) ]
   Skin electrical capacitance value is measured with Corneometer CM825
3. Change from baseline of Deep skin hydration [ Time Frame: Baseline (T0), 1 month (T1), 2 months (T2) ]
   Tissue dielectric constant of deep skin layers is measured with MoistureMeterD
4. Change from baseline of Epicutaneous pH [ Time Frame: Baseline (T0), 1 month (T1), 2 months (T2) ]
   Surface cutaneous pH is measured with pH meter HI5221
5. Change from baseline of Surface microrelief's regularity [ Time Frame: Baseline (T0), 1 month (T1), 2 months (T2) ]
   Surface microrelief's regularity is performed on skin replicas images acquired by Primos

Secondary Outcome Measures :

1. Change from baseline of itching sensation [ Time Frame: Baseline (T0), 1 month (T1), 2 months (T2) ]
   Each volunteers scored its own itching sensation thanks to a visual analogic scale (VAS from 0 = no itching to 10= strong itching).

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

Italy

DERMING

Milano, MI, Italy, 20149

Sponsors and Collaborators

Derming SRL

More Information

• Responsible Party: Adele Sparavigna, Medical Doctor, Derming SRL
• ClinicalTrials.gov Identifier: NCT03484897
• Other Study ID Numbers: E2117
• First Posted: April 2, 2018
• Last Update Posted: April 2, 2018
• Last Verified: March 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Dermatitis, Atopic; Dermatitis; Skin Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases