Treatment of hyperpigmented spots on human skin

Individuals with solar lentigines on forearm Skin: Does twice daily application of a topical formulation with a new inhibitor of human tyrosinase reduce skin hyperpigmentation?

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN19231900

Enrollment

Registered

2018-01-25

Start date

2012-05-02

Completion date

Unknown

Last updated

2018-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Volar forearms with solar Lentigines, but otherwise healthy skin Skin and Connective Tissue Diseases Volar forearms with solar Lentigines, but otherwise healthy skin

Interventions

Participants qualify for study participation by having at least two solar lentigines appropriate for the intended measurements, i.e., suitable in size and coloration. During a two-day preconditioning

Eligibility

Sex/Gender

All

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
Skin colour contrast of lentigines to surrounding skin is measured using a spectrophotometer at baseline, 4,8, and 12 weeks.	—

Secondary

Measure	Time frame
1. The size and colour of the lentiginous spots is measured using photographs at baseline, 4, 8, and 12 weeks 2. The forearm skin is measured using visual inspections at baseline, 4, 8, 12 weeks for signs of irritation	—

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026