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

Derming

Status: Completed

Conditions: Atopic Dermatitis

Treatments: Other: P927 - LICHTENA DermAD CREMA CORPO

Study type: Interventional

Funder types: Other

Identifiers

NCT03484897

E2117

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

P927 - LICHTENA DermAD CREMA CORPO

Experimental group

Description:

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.

Treatment:

Other: P927 - LICHTENA DermAD CREMA CORPO