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

D

Derming

Status

Completed

Conditions

Atopic Dermatitis

Treatments

Other: P927 - LICHTENA DermAD CREMA CORPO

Study type

Interventional

Funder types

Other

Identifiers

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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