MedPath

Treatment of hyperpigmented spots on human ski

Completed
Conditions
Volar forearms with solar Lentigines, but otherwise healthy skin
Skin and Connective Tissue Diseases
Registration Number
ISRCTN19231900
Lead Sponsor
Beiersdorf AG
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
20
Inclusion Criteria

1. Females/ males between 50 and 70 years of age in generally good health
2. Solar Lentigines on the arms but otherwise healthy, undamaged skin in the test sites
3. Fitzpatrick skin phototype I, II, III or IV
4. Ability to understand the study concept (intellectual capacity and language skills) and to comply with the test schedule and study rules
5. Participant is willing and able to give written informed consent

Exclusion Criteria

1. Active, acute skin ailments in the test sites, for example atopic Dermatitis or eczema
2. Changes to the skin which conflict with study goals
3. Systemic or topical medication which counteract study objectives
4. Medications, taken either orally or applied topically within the last 4 weeks, which impair immune reactions, for example cytostatic agents and cortisone
5. Severe general illness, either currently or within the last 12 months, for example malignant tumor, severe diabetes, severe cardiovascular disease (e.g. cerebral apoplexy, myocardial infarction, bypass or decompensated high blood pressure)

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Skin colour contrast of lentigines to surrounding skin is measured using a spectrophotometer at baseline, 4,8, and 12 weeks.
Secondary Outcome Measures
NameTimeMethod
1. The size and colour of the lentiginous spots is measured using photographs at baseline, 4, 8, and 12 weeks<br>2. The forearm skin is measured using visual inspections at baseline, 4, 8, 12 weeks for signs of irritation
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