Erythema, Skin Inflammation, Sun Damaged Skin
Conditions
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.
Interventions
Application of test products before and after irradiation
Application of test products before and after irradiation
Application of test products before and after irradiation
Sponsors
proDERM GmbH
Amazentis SA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Erythema (skin redness) assessed by Chromameter | 3 days |
| Visual erythema evaluation by a trained grader on a scale of -2 (marked redness) to 3 (no redness) | 3 days |
Countries
Germany
Outcome results
None listed