Effect of a Basic Skin Care Product on the Structural Strength of the Skin

NCT03625167 | Completed Results

• 1 other identifier: CRC-SP-A31
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

The main aim of this study is to investigate in a suction blister model, whether the use of a basic skin care formulation increases the mechanical integrity/adhesion of the dermo-epidermal junction.

Conditions

Healthy Skin

Keywords

skin ageing; suction blister; dermo-epidermal junction

Outcome Measures

Primary Outcomes (2)

• Blistering Time (Full Blister)

  Duration from the start of suction pressure to the development of a full blister (measured in minutes)

  Day 28±2, Day 56±2

• Blistering Time (First Vesicles)

  Duration from the start of suction pressure to the development of first macroscopically visible vesicles (measured in minutes)

  Day 28±2, Day 56±2

Secondary Outcomes (3)

• Epidermal Thickness

  Baseline, Day 28±2, Day 56±2

• Epidermal Hydratation: Stratum Corneum Hydration

  Baseline, Day 14±1, Day 28±2, Day 42±2, Day 56±2

• Epidermal Hydratation: Epidermal Moisture

  Baseline, Day 14±1, Day 28±2, Day 42±2, Day 56±2

Study Arms (2)

Treatment with petrolatum

EXPERIMENTAL

In each healthy volunteer, one of the two forearms is randomly assigned to the intervention. This forearm is treated with petrolatum for 4 respectively 8 weeks.

Other: Treatment with petrolatum

Control

NO INTERVENTION

The control forearm will remain untreated throughout the study.

Interventions

Treatment with petrolatum OTHER

Petrolatum is applied twice daily to the intervention arm.

Treatment with petrolatum

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Healthy volunteers and/or with stable chronic condition (e.g. controlled hypertension)
• Female,
• to 85 years,
• Caucasian,
• Phototype I to III according to the Fitzpatrick classification,
• Body Mass Index between 20 and 28 kg/m2,
• Non-smoker of at least one year,
• Absence of skin diseases or scars in the skin area of interest,
• Absence of tattoos in the skin area of interest,
• Able to give written informed consent,
• Willing and able to fulfill the study requirements

You may not qualify if:

• Known or suspected defect of healing,
• Diabetes mellitus
• Any acute or chronic pathology that may interfere with the trial conduct, from investigator point of view,
• Acute or chronic wounds in the skin area of interest,
• Any skin affection which may interfere with the trial assessment, like urticaria,, psoriasis or scar on investigational areas,
• Medical history of skin cancer,
• History or establishment of diabetes or pre-diabetes,
• Any hyper-sensibility to one of the compounds of the investigational product,
• Any regular treatment which may affect the blood coagulation and hemostasis (anticoagulant medications, NSAID, etc.) before the suction blister induction (Visit 3 and Visit 5), one NSAID to treat headache within four days is allowed
• Any physical treatment (like laser or surgery) on the arms within the last 6 months,
• Use of topical or systemic treatment on the investigational areas within the past 4 weeks (topical hyaluronan, anti-inflammatory drugs, corticoids, retinoids, vitamin C, etc.) that would interfere with assessment and/or investigational treatments,
• Allergy to band-aid or to metals (such as nickel),
• UV sessions or strong sun exposure of the arms during the study period,
• Subject who cannot be contacted easily in case of necessity,
• Current participation in any other clinical study

Sponsors & Collaborators

• Prof. Dr. Jan Kottner: lead

Study Sites (1)

Clinical Research Center for Hair and Skin Science, Department of Dermatology and Allergy, Charite University Berlin

Berlin, 10117, Germany

Location

Related Publications (1)

• El Genedy-Kalyoncu M, Richter C, Surber C, Blume-Peytavi U, Kottner J. The effect of a basic skin care product on the structural strength of the dermo-epidermal junction: An exploratory, randomised, controlled split-body trial. Int Wound J. 2022 Feb;19(2):426-435. doi: 10.1111/iwj.13643. Epub 2021 Jun 13.

  PMID: 34121334 RESULT

MeSH Terms

Interventions

Therapeutics; Petrolatum

Intervention Hierarchy (Ancestors)

Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Monira El Genedy-Kalyoncu
• Organization: Charité - Universitätsmedizin Berlin

monira.el-genedy@charite.de

+49 30 450 529 434

Study Officials

• Jan Kottner, Prof. Dr.

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of the Institute of Clinical Nursing Science

Study Record Dates

• First Submitted: August 1, 2018
• First Posted: August 10, 2018
• Study Start: July 31, 2018
• Primary Completion: December 11, 2018
• Study Completion: December 31, 2018
• Last Updated: February 19, 2025
• Results First Posted: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)