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

Primary Purpose

Erythema, Sun Damaged Skin, Skin Inflammation

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Topical Placebo Cream
Topical Cream with 0.5% Active
Topical Cream with 1% Active
Sponsored by
Amazentis SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Erythema

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • proderm GmbH

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Skin UVB irradiated 1.25MED

Skin UVB irradiated 1.6MED

Untreated Skin

Arm Description

Outcomes

Primary Outcome Measures

Erythema (skin redness) assessed by Chromameter
Visual erythema evaluation by a trained grader on a scale of -2 (marked redness) to 3 (no redness)

Secondary Outcome Measures

Full Information

First Posted
March 19, 2022
Last Updated
April 5, 2023
Sponsor
Amazentis SA
Collaborators
proDERM GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT05300542
Brief Title
Efficacy Study of a Novel Skin Health Product to Reduce an UVB Induced Erythema
Official Title
Efficacy Study of a Novel Cosmetic Product to Reduce an UVB Induced Erythema
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
March 17, 2022 (Actual)
Primary Completion Date
March 31, 2022 (Actual)
Study Completion Date
April 13, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amazentis SA
Collaborators
proDERM GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erythema, Sun Damaged Skin, Skin Inflammation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Skin UVB irradiated 1.25MED
Arm Type
Experimental
Arm Title
Skin UVB irradiated 1.6MED
Arm Type
Experimental
Arm Title
Untreated Skin
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Topical Placebo Cream
Intervention Description
Application of test products before and after irradiation
Intervention Type
Other
Intervention Name(s)
Topical Cream with 0.5% Active
Intervention Description
Application of test products before and after irradiation
Intervention Type
Other
Intervention Name(s)
Topical Cream with 1% Active
Intervention Description
Application of test products before and after irradiation
Primary Outcome Measure Information:
Title
Erythema (skin redness) assessed by Chromameter
Time Frame
3 days
Title
Visual erythema evaluation by a trained grader on a scale of -2 (marked redness) to 3 (no redness)
Time Frame
3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof. Dr. med. Klaus-Peter Wilhelm, Dermatologist, MD
Organizational Affiliation
proDERM GmbH
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Dr. rer. nat. Sabrina Laing, MD
Organizational Affiliation
proDERM GmbH
Official's Role
Principal Investigator
Facility Information:
Facility Name
proderm GmbH
City
Schenefeld
Country
Germany

12. IPD Sharing Statement

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

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