Efficacy Study of a Novel Skin Health Product to Reduce an UVB Induced Erythema
NCT ID: NCT05300542
Last Updated: 2023-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
22 participants
INTERVENTIONAL
2022-03-17
2022-04-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
QUADRUPLE
Study Groups
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Skin UVB irradiated 1.25MED
Topical Placebo Cream
Application of test products before and after irradiation
Topical Cream with 0.5% Active
Application of test products before and after irradiation
Topical Cream with 1% Active
Application of test products before and after irradiation
Skin UVB irradiated 1.6MED
Topical Placebo Cream
Application of test products before and after irradiation
Topical Cream with 0.5% Active
Application of test products before and after irradiation
Topical Cream with 1% Active
Application of test products before and after irradiation
Untreated Skin
No interventions assigned to this group
Interventions
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Topical Placebo Cream
Application of test products before and after irradiation
Topical Cream with 0.5% Active
Application of test products before and after irradiation
Topical Cream with 1% Active
Application of test products before and after irradiation
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
Yes
Sponsors
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proDERM GmbH
INDUSTRY
Amazentis SA
INDUSTRY
Responsible Party
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Principal Investigators
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Prof. Dr. med. Klaus-Peter Wilhelm, Dermatologist, MD
Role: STUDY_CHAIR
proDERM GmbH
Dr. rer. nat. Sabrina Laing, MD
Role: PRINCIPAL_INVESTIGATOR
proDERM GmbH
Locations
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proderm GmbH
Schenefeld, , Germany
Countries
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Other Identifiers
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22.0103-65
Identifier Type: OTHER
Identifier Source: secondary_id
22.02.AMZ
Identifier Type: -
Identifier Source: org_study_id
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