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

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy Study of a Novel Cosmetic Product to Reduce an UVB Induced Erythema

Conditions
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Erythema, Sun Damaged Skin, Skin Inflammation

Intervention / Treatment
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* Other: Topical Placebo Cream
* Other: Topical Cream with 0.5% Active
* Other: Topical Cream with 1% Active


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Skin UVB irradiated 1.25MED<br> | Other: Topical Placebo Cream<br>* Application of test products before and after irradiation<br>Other: Topical Cream with 0.5% Active<br>* Application of test products before and after irradiation<br>Other: Topical Cream with 1% Active<br>* Application of test products before and after irradiation<br>|
| Experimental: Skin UVB irradiated 1.6MED<br> | Other: Topical Placebo Cream<br>* Application of test products before and after irradiation<br>Other: Topical Cream with 0.5% Active<br>* Application of test products before and after irradiation<br>Other: Topical Cream with 1% Active<br>* Application of test products before and after irradiation<br>|
| No Intervention: Untreated Skin<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |