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Completed

NCT Number: NCT04512274

Skin Protectant Properties of Omeza Collagen Matrix on Damaged Skin

Single-blind within subject comparison study conducted to investigate the skin protectant properties of Omeza Collagen Matrix on damaged skin

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Princeton Research Corporation

Chelmsford, Essex, CM2 6UA, United Kingdom

About this study

This study was conducted in 22 healthy subjects to determine the skin protectant and anti-inflammatory properties of the test product.

For the skin protectant assay the test article was applied to the forearm and covered with gauze for 10 minutes before assessment of irritation and TEWL readings.

An inflammatory skin response was induced by a SLS solution 24 hours prior to application of the test article. The test article was applied for 10 minutes at the site of inflammation. The test site was then graded for irritation and TEWL readings.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Subject is a healthy male or female, aged 18 years or older.
  • Subject has signed a written Informed Consent.

Exclusion criteria

  • Pregnancy or lactation.
  • Inadequate precaution or procedure to prevent pregnancy (women of child bearing potential only).
  • A current skin disease of any type at the test site (e.g. eczema, psoriasis)
  • Heavy alcohol consumption in the opinion of the investigator.
  • A fever in the last 12 hours, prior to the initial patch application.
  • Significant past medical history of hepatic, renal, cardiac, pulmonary, digestive, haematological, neurological, locomotor or psychiatric disease, which in the opinion of the Investigator would compromise the safety of the subject.
  • History of malignant disease.
  • Insulin dependent or non-insulin dependent diabetes.
  • Concurrent medication likely to affect the response to the test articles or confuse the results of the study, i.e. routine high dosage use of antiinflammatory drugs (aspirin, ibuprofen, corticosteroids).
  • Known sensitivity to the treatment solutions or their constituents including patch materials.
  • Sensitisation or questionable sensitisation in a Repeat Insult Patch Test.
  • Use of self-tanning lotion on the test area, one week previous to the start of the study.

Treatment and study plan

Test Article

Device

Omeza Collagen Matrix

Primary outcomes

  1. Transepidermal Water Loss (TEWL)

    Time frame: 24 hours

    Assessment of water evaporation (TWEL) based upon diffusion principle after 24 hour injury

  2. Transepidermal Water Loss (TEWL)

    Time frame: 48 hours

    Assessment of water evaporation (TWEL) based upon diffusion principle

  3. Transepidermal Water Loss (TEWL)

    Time frame: 72 hours

    Assessment of water evaporation (TWEL) based upon diffusion principle

  4. Transepidermal Water Loss (TEWL)

    Time frame: 96 hours

    Assessment of water evaporation (TWEL) based upon diffusion principle

Secondary outcomes

  1. Erythema

    Time frame: 24 hours

    Irritancy Grading on a 0-4 scale

  2. Erythema

    Time frame: 48 hours

    Irritancy Grading on a 0-4 scale

  3. Erythema

    Time frame: 72 hours

    Irritancy Grading on a 0-4 scale

  4. Erythema

    Time frame: 96 hours

    Irritancy Grading on a 0-4 scale

Sponsors and collaborators

Lead sponsor

Omeza, LLC

Industry

Registry information

Official study title

A Single Center Study in 22 Healthy Male and Female Subjects to Investigate the Skin Protectant and Anti-Inflammatory Properties of Omeza Collagen Matrix on Damaged Skin

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Aug 13, 2020
Registry last updated
Sep 30, 2022

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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