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

Not Applicable

Completed

• Conditions: Skin Inflammation; Erythema; Sun Damaged Skin

• Registration Number: NCT05300542
• Lead Sponsor: Amazentis SA

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-17
• Study First Submitted: 2022-03-19
• Study First Submitted QC: 2022-03-19
• Study First Posted: 2022-03-29
• Primary Completion: 2022-03-31
• Study Completion: 2022-04-13
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-05
• Last Update Posted: 2023-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Trial Locations

Locations (1)

proderm GmbH; 🇩🇪 Schenefeld, Germany