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

Erythema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05300542
• Other study ID #: 22.02.AMZ
• Secondary ID: 22.0103-65
• Status: Completed
• Phase: N/A
• Start date: March 17, 2022
• Est. completion date: April 13, 2022

Study information

• Verified date: April 2023
• Source: Amazentis SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: April 13, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Dermatitis
• Erythema
• Inflammation
• Skin Inflammation
• Sun Damaged Skin

Intervention

Other:
• 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

Locations

Country	Name	City	State
Germany	proderm GmbH	Schenefeld

Sponsors (2)

Lead Sponsor	Collaborator
Amazentis SA	proDERM GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Erythema (skin redness) assessed by Chromameter		3 days
Primary	Visual erythema evaluation by a trained grader on a scale of -2 (marked redness) to 3 (no redness)		3 days