Last updated: 11/03/2018 22:22:28
A Pilot Study to Assess Itchy, Dry Skin in Healthy Subjects
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Pilot Study to Assess Itchy, Dry Skin in Healthy Subjects
Trial description: This will be a randomized, two-product parallel-group, examiner-blind pilot study which will assess relief from itchy, dry skin in healthy adults. Itch relief and intensity (associated with dry skin) will be assessed on two different scales.
Primary purpose:
Not applicable
Trial design:
Parallel Assignment
Masking:
Single (Investigator)
Allocation:
Randomized
Primary outcomes:
Assessment of relief from itchy and dry skin
Timeframe: From baseline to 8 hours
Assessment of intensity of itchy and dry skin
Timeframe: From baseline to 8 hours
Secondary outcomes:
Not applicable
Interventions:
Other: Test cream
Other: Reference cream
Enrollment:
63
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Skin Care
Product
GSK1507202, GSK2695294, GSK2695982
Collaborators
TKL Research Inc.
Study date(s)
October 2014 to November 2014
Type
Interventional
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18 - 85 Year
Accepts healthy volunteers
yes
- Participant demonstrating understanding of the study and willingness to participate
- Aged 18 to 85 years at the time of consent
- Women who are known to be pregnant or who are intending to become pregnant over the duration of the study
- Women who are known to be pregnant or who are intending to become pregnant over the duration of the study
Inclusion and exclusion criteria
Inclusion criteria:
- Participant demonstrating understanding of the study and willingness to participate
- Aged 18 to 85 years at the time of consent
- Understands and is willing, able and likely to comply with all study procedures and restrictions
- Good general and mental health with, in the opinion of the investigator or medically qualified designee: a) No clinically significant and relevant abnormalities in medical history or upon physical examination. b) Absence of any condition that could affect the subject’s safety or well being or their ability to understand and follow study procedures and requirements
- Participant has itchy, dry skin that prompts moisturizer use
Exclusion criteria:
- Women who are known to be pregnant or who are intending to become pregnant over the duration of the study
- Women who are known to be pregnant or who are intending to become pregnant over the duration of the study
- Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
- Recent history (within the last year) of alcohol or other substance abuse
- Use of oral corticosteroids or immunosuppressive medications within 4 weeks or topical corticosteroids, anti-histamines or within 2 weeks of visit 1
- Current use of any medication, that in the opinion of the investigator, will affect study assessments
- Clinically significant chronic or acute concurrent illnesses (e.g. psoriasis, atopic dermatitis in active flare etc.) that, in the opinion of the Investigator, may interfere with the study assessments
- An employee of the sponsor or the study site or members of their immediate family
- Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit
- Previous participation in this study
Trial location(s)
No location data available.
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2014-14-11
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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