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OpenTrials
Completed

NCT Number: NCT03464890

Soothing and Re-epithelizing Activity of New Cosmetic Formulations in Comparison to Placebo and Untreated Control Area

Open clinical study to evaluate the soothing and re-epithelizing activity of a single application of two cometic formulations ("P926 - LICHTENA DermAD CREMA VISO" and "P927 - LICHTENA DermAD CREMA CORPO") on experimentally induced erythema by repeated tape stripping on the forearm (volar surface) of 20 healthy volunteers.

Study products activity was assessed in comparison to placebo ("P926P - LICHTENA DermAD CREMA VISO - PLACEBO") and versus untreated control area.

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Key information

Conditions

Sensitive Skin

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

  • Volunteers of both sexes
  • TEWL value on tested skin areas immediately after tape stripping >15g/m2-h
  • volunteers in a good general state of health in the Investigator opinion
  • volunteers not taking drugs or undergoing surgical procedure
  • volunteers who are giving a written informed consent.

Exclusion criteria

  • Pregnancy (only for female subjects)
  • lactation (only for female subjects)
  • TEWL value on tested skin areas immediately after tape stripping <15g/m2-h
  • change in the normal habits in the last month
  • participation in a similar study during the previous month
  • known allergy to one or several ingredients of the products on trial.
  • 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

P926 - LICHTENA DermAD CREMA VISO

Other

The study product was applied on a skin areas of about 14 cm2 of the forearm, defined turning on the right and left side in accordance with a randomization list, on which an erythema has been experimentally induced by repeated tape stripping.

P927 - LICHTENA DermAD CREMA CORPO

Other

The study product was applied on a skin areas of about 14 cm2 of the forearm, defined turning on the right and left side in accordance with a randomization list, on which an erythema has been experimentally induced by repeated tape stripping.

P926 - LICHTENA DermAD CREMA VISO - PLACEBO

Other

The study product was applied on a skin areas of about 14 cm2 of the forearm, defined turning on the right and left side in accordance with a randomization list, on which an erythema has been experimentally induced by repeated tape stripping.

Untreated control area

Other

Untreated skin area of about 14 cm2 of the forearm, defined turning on the right and left side in accordance with a randomization list, on which an erythema has been experimentally induced by repeated tape stripping.

Primary outcomes

  1. Change from baseline of skin erythema index

    Time frame: Baseline (T0), 1 hour (T1h), 24 hours (T24h)

    The instrumental measurement of erythema is performed by the use of an optical densitometer (X-RITE 404)

  2. Change from baseline of skin redness

    Time frame: Baseline (T0), 1 hour (T1h), 24 hours (T24h)

    The instrumental measurement of skin redness is performed by the use of an optical colorimetry (Chroma Meter CR-200®)

  3. Change from baseline of Transepidermal water loss (TEWL)

    Time frame: Baseline (T0), 1 hour (T1h), 24 hours (T24h)

    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.

  4. Change from baseline of Superficial skin hydration

    Time frame: Baseline (T0), 1 hour (T1h), 24 hours (T24h)

    Skin electrical capacitance value is measured with Corneometer CM825

  5. Change from baseline of deep skin hydration

    Time frame: Baseline (T0), 1 hour (T1h), 24 hours (T24h)

    Tissue dielectric constant of deep skin layers is measured with MoistureMeterD

  6. Change from baseline of Epicutaneous pH

    Time frame: Baseline (T0), 1 hour (T1h), 24 hours (T24h)

    Surface cutaneous pH is measured with pH meter HI5221

  7. Change from baseline of Surface microrelief's regularity

    Time frame: Baseline (T0), 1 hour (T1h), 24 hours (T24h)

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

Sponsors and collaborators

Lead sponsor

Derming SRL

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 14, 2018
Registry last updated
Mar 27, 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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