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

NCT03484897 | Completed

• 1 other identifier: E2117
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (5)

• Change from baseline of Transepidermal water loss (TEWL)

  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.

  Baseline (T0), 1 month (T1), 2 months (T2)

• Change from baseline of Superficial skin hydration

  Skin electrical capacitance value is measured with Corneometer CM825

  Baseline (T0), 1 month (T1), 2 months (T2)

• Change from baseline of Deep skin hydration

  Tissue dielectric constant of deep skin layers is measured with MoistureMeterD

  Baseline (T0), 1 month (T1), 2 months (T2)

• Change from baseline of Epicutaneous pH

  Surface cutaneous pH is measured with pH meter HI5221

  Baseline (T0), 1 month (T1), 2 months (T2)

• Change from baseline of Surface microrelief's regularity

  Surface microrelief's regularity is performed on skin replicas images acquired by Primos

  Baseline (T0), 1 month (T1), 2 months (T2)

Secondary Outcomes (1)

• Change from baseline of itching sensation

  Baseline (T0), 1 month (T1), 2 months (T2)

Study Arms (1)

P927 - LICHTENA DermAD CREMA CORPO

EXPERIMENTAL

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

Interventions

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

P927 - LICHTENA DermAD CREMA CORPO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Derming SRL: lead

Study Sites (1)

DERMING

Milan, MI, 20149, Italy

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: March 26, 2018
• First Posted: April 2, 2018
• Study Start: January 12, 2018
• Primary Completion: March 20, 2018
• Study Completion: March 20, 2018
• Last Updated: April 2, 2018

Record last verified: 2018-03

Locations

IT (1)