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

Amazentis

Status: Completed

Conditions: Skin Inflammation; Erythema; Sun Damaged Skin

Treatments: Other: Topical Cream with 1% Active; Other: Topical Placebo Cream; Other: Topical Cream with 0.5% Active

Study type: Interventional

Funder types: Industry

Identifiers

NCT05300542

22.02.AMZ

22.0103-65 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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22 participants in 3 patient groups

Skin UVB irradiated 1.25MED

Experimental group

Treatment:

Other: Topical Cream with 1% Active

Other: Topical Placebo Cream

Other: Topical Cream with 0.5% Active

Skin UVB irradiated 1.6MED

Experimental group

Treatment:

Other: Topical Cream with 1% Active

Other: Topical Placebo Cream

Other: Topical Cream with 0.5% Active

Untreated Skin

No Intervention group