Efficacy Study of a Novel Skin Health Product to Reduce an UVB Induced Erythema

April 5, 2023 updated by: Amazentis SA

Efficacy Study of a Novel Cosmetic Product to Reduce an UVB Induced Erythema

The aim of this study is to determine the erythema-reducing efficacy of a test product in two concentrations on a light sunburn induced by a sun simulator compared to an untreated control and a placebo product.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Schenefeld, Germany
        • proDERM GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Written Informed Consent to participate in the study
  • Willingness to actively participate in the study and to come to the scheduled visits
  • Female and/or male
  • From 18 to 65 years of age
  • Uniform skin color and no erythema or dark pigmentation in the test area
  • ITA° > 28 in the test area

Exclusion Criteria:

  • Female subjects: Pregnancy or lactation
  • Drug addicts, alcoholics
  • AIDS, HIV-positive or infectious hepatitis
  • Conditions which exclude a participation or might influence the test reaction/evaluation
  • Participation or being in the waiting period after participation in cosmetic and/or pharmaceutical studies pertaining to the test area
  • One of the following illnesses with reduced physical capability/fitness: asthma (symptom-free allergic asthma is not an exclusion criterion), hypertension, cardiovascular diseases
  • Cancer not being diagnosed as cured and requiring chemotherapy, irradiation and/or hormonal treatment within the last 2 years
  • Insulin-dependent diabetes mellitus
  • Electronic implant (e.g. pace maker, insulin pump, hearing aid, and the like) that cannot be removed during irradiation
  • Documented allergies to cosmetic products and/or ingredients
  • Active skin disease at the test area
  • Irregularly tanned skin in the test area
  • Medical history of dysplastic nevi, melanoma or other skin carcinoma
  • Medical history of abnormal response to sunlight
  • Regular use of tanning beds (more than 10 times within the last 6 months)
  • Wounds, moles, tattoos, scars, irritated skin, excessive hair growth, etc. at the test area that could influence the investigation
  • Usage of medication with known photo-toxic and/or photo-sensitizing potential (e.g. some antibiotics, blood pressure regulating agents and antidepressants agents; hypericum perforatum) within the last 14 days prior to the start of the study and/or throughout the entire course of the study
  • Any topical medication at the test area within the last 7 days prior to the start of the study and/or throughout the entire course of the study
  • Systemic therapy with immuno-suppressive drugs (e.g. corticosteroids) and/or antihistamines (e.g. antiallergics) within the last 7 days prior to the start of the study and/or throughout the entire course of the study
  • Systemic therapy with anti-phlogistic agents or analgetics (e.g. diclophenac), except for minor pain relief medicine like acetylsalicylic acid or paracetamol within the last 3 days prior to the start of the study and/or throughout the entire course of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Skin UVB irradiated 1.25MED
Other: Topical Placebo Cream
Application of test products before and after irradiation
Other: Topical Cream with 0.5% Active
Application of test products before and after irradiation
Other: Topical Cream with 1% Active
Application of test products before and after irradiation
Experimental: Skin UVB irradiated 1.6MED
Other: Topical Placebo Cream
Application of test products before and after irradiation
Other: Topical Cream with 0.5% Active
Application of test products before and after irradiation
Other: Topical Cream with 1% Active
Application of test products before and after irradiation
No Intervention: Untreated Skin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Erythema (skin redness) assessed by Chromameter
Time Frame: 3 days
3 days
Visual erythema evaluation by a trained grader on a scale of -2 (marked redness) to 3 (no redness)
Time Frame: 3 days
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amazentis SA

Collaborators

proDERM GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 17, 2022

Primary Completion (Actual)

March 31, 2022

Study Completion (Actual)

April 13, 2022

Study Registration Dates

First Submitted

March 19, 2022

First Submitted That Met QC Criteria

March 19, 2022

First Posted (Actual)

March 29, 2022

Study Record Updates

Last Update Posted (Actual)

April 6, 2023

Last Update Submitted That Met QC Criteria

April 5, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22.02.AMZ
  • 22.0103-65 (Other Identifier: proderm)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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