Clinical trial NCT05300542: 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
Overall status: COMPLETED
Phase: NA
Conditions: Erythema
Sun Damaged Skin
Skin Inflammation
Lead sponsor: Amazentis SA
Sponsor class: INDUSTRY
Collaborators: name: proDERM GmbH
First posted: 2022-03-29
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Erythema (skin redness) assessed by Chromameter
timeFrame: 3 days
measure: Visual erythema evaluation by a trained grader on a scale of -2 (marked redness) to 3 (no redness)
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Schenefeld
country: Germany
facility: proderm GmbH
Study officials:
affiliation: proDERM GmbH
name: Prof. Dr. med. Klaus-Peter Wilhelm, Dermatologist, MD
role: STUDY_CHAIR
affiliation: proDERM GmbH
name: Dr. rer. nat. Sabrina Laing, MD
role: PRINCIPAL_INVESTIGATOR
References: