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

Sponsor
Amazentis SA (Industry)
Overall Status
Completed
CT.gov ID
NCT05300542
Collaborator
proDERM GmbH (Industry)
22
Enrollment
1
Location
3
Arms
27
Actual Duration (Days)
24.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Topical Placebo Cream
  • Other: Topical Cream with 0.5% Active
  • Other: Topical Cream with 1% Active
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
22 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Efficacy Study of a Novel Cosmetic Product to Reduce an UVB Induced Erythema
Actual Study Start Date :
Mar 17, 2022
Actual Primary Completion Date :
Mar 31, 2022
Actual Study Completion Date :
Apr 13, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Skin UVB irradiated 1.25MED

Other: Topical Placebo Cream
Application of test products before and after irradiation

Other: Topical Cream with 0.5% Active
Application of test products before and after irradiation

Other: Topical Cream with 1% Active
Application of test products before and after irradiation
Experimental: Skin UVB irradiated 1.6MED

Other: Topical Placebo Cream
Application of test products before and after irradiation

Other: Topical Cream with 0.5% Active
Application of test products before and after irradiation

Other: Topical Cream with 1% Active
Application of test products before and after irradiation
No Intervention: Untreated Skin

Outcome Measures

Primary Outcome Measures

  1. Erythema (skin redness) assessed by Chromameter [3 days]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 proderm GmbH Schenefeld Germany

Sponsors and Collaborators

  • Amazentis SA
  • proDERM GmbH

Investigators

  • Study Chair: Prof. Dr. med. Klaus-Peter Wilhelm, Dermatologist, MD, proDERM GmbH
  • Principal Investigator: Dr. rer. nat. Sabrina Laing, MD, proDERM GmbH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Amazentis SA
ClinicalTrials.gov Identifier:
NCT05300542
Other Study ID Numbers:
  • 22.02.AMZ
  • 22.0103-65
First Posted:
Mar 29, 2022
Last Update Posted:
Apr 14, 2022
Last Verified:
Apr 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Erythema
Dermatitis
Inflammation

Study Results

No Results Posted as of Apr 14, 2022