Mode
Text Size
Log in / Sign up
N/A N=17 Randomized Prevention

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

Healthy Skin

Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: Blistering Time (Full Blister) — 63; 54; 65; 62 Minutes

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Treatment with petrolatum (Other)
Age
Older Adult · 65+ yrs
Sex
Female
Sponsor
Prof. Dr. Jan Kottner
Primary completion
Dec 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Blistering Time (Full Blister)
63; 54; 65; 62
PRIMARY
Blistering Time (First Vesicles)
43; 39; 47; 27
SECONDARY
Epidermal Thickness
78; 68; 68; 72; 75; 71
SECONDARY
Epidermal Hydratation: Stratum Corneum Hydration
43; 40; 41; 36; 39; 36
SECONDARY
Epidermal Hydratation: Epidermal Moisture
47; 46; 46; 41; 43; 41

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.

Eligibility Criteria

Inclusion Criteria

  • Healthy volunteers and/or with stable chronic condition (e.g. controlled hypertension)
  • Female,
  • 65 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

Exclusion Criteria

  • 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03625167). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search