Use Test: Dermowas Body Lotion pH 4 vs. pH 5.8

Dr. August Wolff

Status: Completed

Conditions: Healthy

Treatments: Other: WO 5001; Other: WO 5000

Study type: Interventional

Funder types: Industry

Identifiers

NCT04538183

DK-01/2017

Details and patient eligibility

About

The objective of the study was to examine whether normalizing of the pH by acidification through topical treatment helps to strengthen the skin barrier, to induce epidermal differentiation and to reduce inflammation in healthy individuals.

Full description

Previous studies have shown that an emollient adjusted to pH 4 has favorable effects to the skin of aged individuals. The objective of the study was to examine whether normalizing of the pH by acidification through topical treatment helps to strengthen the skin barrier, to induce epidermal differentiation and to reduce Inflammation. The effect of a cosmetic oil-in-water (O/W) emulsion adjusted to pH 4 in comparison to the same emulsion adjusted to pH 5.8 on the integrity of the skin barrier and the mechanical stability was examined in healthy volunteers from age 18 to 75 years.

Enrollment: 25 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male and female volunteers (75 % women and 25 % men)
• Aged 18 - 75 years
• Healthy skin
• Informed consent was given

Exclusion criteria

• Atopic diathesis, atopic dermatitis and other skin diseases with a disrupted skin barrier
• Dermatitis and other skin diseases in the test site
• Birthmarks, tattoos, scars and other abnormalities in the test site, which may influence the measurements
• Women: pregnancy and breastfeeding
• Known contact sensitization
• Severe systemic diseases
• Regular use of sauna and solarium
• Intensive UV exposure
• Topical use of drugs in the test site four weeks before and during the study
• Systemic administration of anti-inflammatory, immune-modulating and antibiotic drugs
• Previous participation in other studies within the last month before the study
• Alcohol and drug misuse
• Missing awareness and inability to follow the instructions of the study staff
• Other reasons which according to the study leader speak against the participation in the study

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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25 participants in 3 patient groups

WO 5000

Experimental group

Description:

Body lotion pH 4 for topical application

Treatment:

Other: WO 5000

WO 5001

Experimental group

Description:

Body lotion pH 5.8 for topical application

Treatment:

Other: WO 5001

No product use

No Intervention group

Description:

Untreated control area