N/A
N=17
Effect of a Basic Skin Care Product on the Structural Strength of the Skin
Healthy Skin
Bottom Line
View on ClinicalTrials.gov: NCT03625167 ↗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
| Outcome | Result | p-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
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.