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Completed

NCT Number: NCT05300542

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

proderm GmbH

Schenefeld, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Topical Placebo Cream

Other

Application of test products before and after irradiation

Topical Cream with 0.5% Active

Other

Application of test products before and after irradiation

Topical Cream with 1% Active

Other

Application of test products before and after irradiation

Primary outcomes

  1. Erythema (skin redness) assessed by Chromameter

    Time frame: 3 days

  2. Visual erythema evaluation by a trained grader on a scale of -2 (marked redness) to 3 (no redness)

    Time frame: 3 days

Sponsors and collaborators

Lead sponsor

Amazentis SA

Industry

Collaborators

  • proDERM GmbH

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 29, 2022
Registry last updated
Apr 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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