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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05300542
Other study ID # 22.02.AMZ
Secondary ID 22.0103-65
Status Completed
Phase N/A
First received
Last updated
Start date March 17, 2022
Est. completion date April 13, 2022

Study information

Verified date April 2023
Source Amazentis SA
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date April 13, 2022
Est. primary completion date March 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Intervention

Other:
Topical Placebo Cream
Application of test products before and after irradiation
Topical Cream with 0.5% Active
Application of test products before and after irradiation
Topical Cream with 1% Active
Application of test products before and after irradiation

Locations

Country Name City State
Germany proderm GmbH Schenefeld

Sponsors (2)

Lead Sponsor Collaborator
Amazentis SA proDERM GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Erythema (skin redness) assessed by Chromameter 3 days
Primary Visual erythema evaluation by a trained grader on a scale of -2 (marked redness) to 3 (no redness) 3 days
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