Plain English Summary
Background and study aims
Solar lentigines are patches of darkened skin that us caused by exposure to ultraviolet (UV) radiation. Some people like to try to reduce the look of these spots using treatments to reduce the lesions. This study aims to examine if a new treatment option, using a topical formulation with a new inhibitor of human tryosinase, can reduce the look of the spots.
Who can participate?
Adults aged 50 to 70 years old who have solar lentigines.
What does the study involve?
Participants have one spot treated with a gel formulation containing an new active ingredient to reduce hyperpigmentation and have one spot is treated with the gel but without the active ingredient. The colour, size and the surrounding skin is assessed at four, 8 and 12 weeks after treatment to assess if there is any impact of the two different treatments.
What are the possible benefits and risks of participating?
The active ingredient may reduce the visibility of the hyper pigmented spots. It participants have sensitive individuals, irritation might occur in the treated skin sites.
Where is the study run from?
BDF Test Center (Germany)
When is the study starting and how long is it expected to run for?
March 2012 to November 2012
Who is funding the study?
Beiersdorf AG (Germany)
Who is the main contact?
Dr Ludger Kolbe (Scientific)
Trial website
Contact information
Type
Scientific
Primary contact
Dr Ludger Kolbe
ORCID ID
http://orcid.org/0000-0001-8608-8901
Contact details
Beiersdorf AG
BF 519
Unnastrasse 48
Hamburg
20245
Germany
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
ID 41640/ 42307
Study information
Scientific title
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?
Acronym
Study hypothesis
The tyrosinase Inhibitor W630 reduces hyperpigmentation on human skin.
Ethics approval
Institutional Ethics Review Board of Beiersdorf AG, 20/03/2012, ref: ID 41640/42307
Study design
Single center interventional study, vehicle controlled. solar lentigines on volar forearm skin treated twice daily, either with the formulation containing the active ingredient or the basic formulation without the active. Evaluation of skin hyperpigmentation before treatment (baseline) and after 4, 8, and 12 weeeks of Treatment. Comparison (intensity of hyperpigmentation) to baseline and vehicle treated site.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
No available in web format, please use the contact details below to request a patient information
Condition
Volar forearms with solar Lentigines, but otherwise healthy skin
Intervention
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 period, prior to the baseline visit, participants are not allowed to use any moisturizing skin care products on the test sites. At the baseline visit, the color of the spots and the surrounding skin is measured by spectrophotometry. Treatment locations are based upon the positions of the available spots, location of the measured spots is documented by clinical photography. After baseline measurements, the investigator demonstrates correct application of the products with a spot applicator, and trains the participants in self-application. Only the selected spots should to be covered with the product without treatment of the surrounding skin. Each subject treats two spots, one lentiginous spot is treated with a product containing the active ingredient, one spot is treated with vehicle. Treatment is assigned to the individual spots according to a randomization scheme (using Siemens PLM Software Teamcenter 11.2.3.1). For a twelve week treatment period, the participants apply the test products twice daily to the spots on the forearm skin, avoiding the surrounding skin.
Intervention type
Other
Phase
Drug names
Primary outcome measures
Skin colour contrast of lentigines to surrounding skin is measured using a spectrophotometer at baseline, 4,8, and 12 weeks.
Secondary outcome measures
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
Overall trial start date
15/03/2012
Overall trial end date
13/11/2012
Reason abandoned
Eligibility
Participant 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
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
20 subjects, 15 to conclude the study
Participant 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)
Recruitment start date
02/05/2012
Recruitment end date
21/08/2012
Locations
Countries of recruitment
Germany
Trial participating centre
BDF Test Center
Hamburg
20245
Germany
Funders
Funder type
Industry
Funder name
Beiersdorf AG
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
To be published after completing all Tests.
IPD sharing statement:
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.
Intention to publish date
30/06/2018
Participant level data
Other
Results - basic reporting
Publication summary