NCT05300542

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 17, 2022

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 29, 2022

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 13, 2022

Completed
Last Updated

April 6, 2023

Status Verified

April 1, 2023

Enrollment Period

14 days

First QC Date

March 19, 2022

Last Update Submit

April 5, 2023

Conditions

ErythemaSun Damaged SkinSkin Inflammation

Outcome Measures

Primary Outcomes (2)

  • Erythema (skin redness) assessed by Chromameter

    3 days

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

    3 days

Study Arms (3)

Skin UVB irradiated 1.25MED

EXPERIMENTAL
Other: Topical Placebo CreamOther: Topical Cream with 0.5% ActiveOther: Topical Cream with 1% Active

Skin UVB irradiated 1.6MED

EXPERIMENTAL
Other: Topical Placebo CreamOther: Topical Cream with 0.5% ActiveOther: Topical Cream with 1% Active

Untreated Skin

NO INTERVENTION

Interventions

Topical Placebo CreamOTHER

Application of test products before and after irradiation

Skin UVB irradiated 1.25MEDSkin UVB irradiated 1.6MED
Topical Cream with 0.5% ActiveOTHER

Application of test products before and after irradiation

Skin UVB irradiated 1.25MEDSkin UVB irradiated 1.6MED
Topical Cream with 1% ActiveOTHER

Application of test products before and after irradiation

Skin UVB irradiated 1.25MEDSkin UVB irradiated 1.6MED

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

proderm GmbH

Schenefeld, Germany

Location

MeSH Terms

Conditions

ErythemaDermatitis

Interventions

Exercise

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue DiseasesSkin ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Prof. Dr. med. Klaus-Peter Wilhelm, Dermatologist, MD

    proDERM GmbH

    STUDY CHAIR

  • Dr. rer. nat. Sabrina Laing, MD

    proDERM GmbH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2022

First Posted

March 29, 2022

Study Start

March 17, 2022

Primary Completion

March 31, 2022

Study Completion

April 13, 2022

Last Updated

April 6, 2023

Record last verified: 2023-04

Locations

DE(1)