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

NCT ID: NCT03484897

Last Updated: 2018-04-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-12
• Study Completion Date: 2018-03-20

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.

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

P927 - LICHTENA DermAD CREMA CORPO

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Derming SRL

OTHER

Sponsor Role: lead

Responsible Party

Adele Sparavigna

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

DERMING

Milan, MI, Italy

Countries

Italy

Other Identifiers

E2117

Identifier Type: -

Identifier Source: org_study_id