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OpenTrials
Completed

NCT Number: NCT03484897

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.

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

DERMING

Milan, MI, 20149, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

P927 - LICHTENA DermAD CREMA CORPO

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

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Derming SRL

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Apr 2, 2018
Registry last updated
Apr 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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