Efficacy Study of a Novel Skin Health Product to Reduce an UVB Induced Erythema
Not Applicable
Completed
- Conditions
- Skin InflammationErythemaSun Damaged Skin
- Interventions
- Other: Topical Placebo CreamOther: Topical Cream with 0.5% ActiveOther: Topical Cream with 1% Active
- 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
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
- Arm && Interventions
Group Intervention Description Skin UVB irradiated 1.6MED Topical Placebo Cream - Skin UVB irradiated 1.25MED Topical Cream with 0.5% Active - Skin UVB irradiated 1.6MED Topical Cream with 1% Active - Skin UVB irradiated 1.25MED Topical Placebo Cream - Skin UVB irradiated 1.25MED Topical Cream with 1% Active - Skin UVB irradiated 1.6MED Topical Cream with 0.5% Active -
- 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
proderm GmbH
🇩🇪Schenefeld, Germany