Skin CareNCT03119688
To Assess the Mildness of a Cosmetic Cleanser in Healthy Participants Using the Forearm-Controlled Application Technique (FCAT)
A study testing Test Product, Reference Product and No Treatment in people with Skin Care, run by GlaxoSmithKline at 2 sites in Brazil.
Trial summary
The objective of this clinical study is to assess the relative mildness of a cosmetic facial cleanser in comparison to water through repeated application to the volar forearm using the FCAT wash procedure. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Care
- What is being tested?
- Test Product, Reference Product and No Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesBrazil
- Study dates
- 8 May 2017to 26 May 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
- Aged between 18 and 65 years inclusive.
- Good general and mental health with, in the opinion of the investigator or medically qualified designee no clinically significant and relevant abnormalities in medical history or upon physical examination.
- Intact skin at the proposed application site; volar forearm.
- Clinical assessment for eligibility by a dermatologist to ensure participant is free of clinically relevant dermatological conditions.
- Fitzpatrick phototype I to IV.
- Trained examiner scores of zero for dryness and redness for each volar forearm at Screening visit (Visit 1) and each allocated test site on each forearm at Baseline visit.
- Agreement to comply with the procedures and requirements of the study and to attend the scheduled assessment visits.
Who cannot join
- Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.
- Women who are breast-feeding
- Any history of significant dermatological diseases or conditions or medical conditions known to alter skin appearance or physiologic response (e.g. diabetes,) which could, in the opinion of the Investigator, preclude topical application of the investigational products and/or interfere with the evaluation of the test site reaction.
- Presence of open sores, pimples, or cysts at the application site.
- Active dermatosis (local or disseminated) that might interfere with the results of the study.
- Considered immune compromised.
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- History of diseases aggravated or triggered by ultraviolet radiation.
- History of atopic dermatitis.
- Participants with dermatographism.
- Currently using any medication which in the opinion of the investigator, may affect the evaluation of the study product, or place the participant at undue risk.
- Use of the following topical or systemic medications: immunosuppressants, antihistamines, non-hormonal anti-inflammatory drugs, and corticosteroids upto 2 weeks before screening visit.
- Oral or topical treatment with vitamin A acid and/or its derivatives up to 1 month before the screening visit.
- Intention of being vaccinated during the study period or has been vaccinated within 3 weeks of the screening visit.
- Currently receiving allergy injections, or received an allergy injection within 7 days prior to Visit 1, or expects to begin injections during study participation.
- Previous history of atopy, allergic reactions, irritation or intense discomfort feelings to topical-use products, cosmetics or medication.
- Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
- Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit.
- Previous participation in this study.
- Recent history (within the last 5 years) of alcohol or other substance abuse.
- Intense sunlight exposure or sun tanning sessions, including use of self-tanning products on the test areas up to 14 days before the Screening evaluation.
- Intention of bathing (in the sea or pool), sauna, water sports, or activities that lead to intense sweating.
- Any Participant who, in the judgment of the Investigator and Dermatologist, should not participate in the study.
- Any skin marks on the test site that might interfere with the evaluation of possible skin reactions (e.g. pigmentation disorders, vascular malformations, scars, tattoos, excessive hair, numerous freckles).
- Prisoner or involuntary incarcerated participant
- Participant from an indigenous tribe.
- An employee of the sponsor or the study site or members of their immediate family.
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
GSK Investigational Site
Campinas, São Paulo, 13084-791
GSK Investigational Site
Campinas, São Paulo, 13084-
About this study
Official title: A Clinical Study to Assess the Mildness of a Cosmetic Cleanser in Healthy Subjects Using the Forearm-Controlled Application Technique (FCAT)
The objective of this clinical study is to assess the relative mildness of a cosmetic facial cleanser in comparison to water through repeated application to the volar forearm using the FCAT wash procedure.
Read the detailed description
This is a test site randomized, examiner blinded, positive and negative-controlled, single-center; Forearm Controlled Application Technique clinical study in healthy participants to assess the mildness potential of a cosmetic facial cleansing product.
- Conditions
- Skin Care
- Being tested
- Test Product, Positive Control, Reference Product, No Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test ProductOther
Micellar cleanser (0.09 ml)
Positive ControlOther
Bar Soap (rubbed for 6 seconds to generate a lather)
Reference ProductOther
Sterile Water (0.09 ml)
No TreatmentOther
Unwashed area of the forearm
| Study group | Role | What they receive |
|---|---|---|
| Test product | Other | 0.09 milliliters (ml) of the cleanser (test product) will be applied on the allocated site on forearm topically. Receives: Other: Test Product |
| Positive Control | Other | Soap bar (positive control) will be applied on the allocated site on forearm by topical dermal administration of towel moistened with sterile water that had been rubbed onto the 100 g bar of soap for 6 seconds to generate a lather. Receives: Other: Positive Control |
| Negative Control | Other | 0.09 ml of sterile water (Reference Product) will be applied on the allocated site on forearm topically. Receives: Other: Reference Product |
| No Treatment | Other | An area of the forearm that remained unwashed and was included in the study as a reference for the treated areas. Receives: Other: No Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Visual Assessment of Dryness at Day 5
Skin dryness was assessed by a trained examiner according to following the scoring scale: 0 (No dryness); 1 (Patches of slight powederiness and occasional patches of small scales may be seen, distribution generalized.); 2 (Generalised slight powederiness, early cracking or occasional small lifting scales may be present); 3 (Generalised moderate powederiness and/or heavy cracking and lifting scales; 4 (Generalised heavy powederiness and/or heavy cracking and lifting scales); 5 (Generalised high cracking and lifting scales, eczematous change may be present, powederiness may be present but not prominent, may see bleeding crack); 6 (Generalised severe cracking, eczematous change may be present, bleeding cracks may be present, scale large may be beginning to disappear). Lower scores reflect less dry skin.
Measured: At Baseline and Day 5 (3 hours post last wash procedure)
Secondary outcomes (5)
Change From Baseline in Visual Assessment of Redness at Day 5
Skin redness was assessed by a trained examiner according to following the scoring scale: 0 (No redness); 1(Barely detectable redness); 2(Slight redness); 3 (Moderate redness); 4 (Heavy or substantial redness); 5 (Extreme redness); 6 (Severe Redness). Lower scores reflect less skin redness.
Measured: At Baseline and Day 5 (3 hours post last wash procedure)
Change From Baseline in Visual Assessment of Dryness at Day 2, 3, and 4
Skin dryness was assessed by a trained examiner according to following the scoring scale: 0 (No dryness); 1 (Patches of slight powederiness and occasional patches of small scales may be seen, distribution generalized.); 2 (Generalised slight powederiness, early cracking or occasional small lifting scales may be present); 3 (Generalised moderate powederiness and/or heavy cracking and lifting scales; 4 (Generalised heavy powederiness and/or heavy cracking and lifting scales); 5 (Generalised high cracking and lifting scales, eczematous change may be present, powederiness may be present but not prominent, may see bleeding crack); 6 (Generalised severe cracking, eczematous change may be present, bleeding cracks may be present, scale large may be beginning to disappear). Lower scores reflect less dry skin.
Measured: At Baseline and Day 2, 3, and 4 (3 hours post last wash procedure)
Change From Baseline in Visual Assessment of Redness at Day 2, 3, and 4
Skin redness was assessed by a trained examiner according to following the scoring scale: 0 (No redness); 1(Barely detectable redness); 2(Slight redness); 3 (Moderate redness); 4 (Heavy or substantial redness); 5 (Extreme redness); 6 (Severe Redness). Lower scores reflect less skin redness.
Measured: At Baseline and Day 2, 3, and 4 (3 hours post last wash procedure)
Change From Baseline in Transepidermal Water Loss (TEWL) at Day 5
TEWL was measured using Tewameter. TEWL measuring principle was based on water vapour gradient determination between two pairs of sensors placed at different distances perpendicularly to the skin. The probe was held in place on the skin for one measurement, for approximately 40 seconds (sec), to ensure that a stable value has been established. The first part of the measurement belonged to the equilibration phase. The values of the last 10 sec were averaged as the actual measurement values. An increase in TEWL values shows damage to the skin barrier function.
Measured: At Baseline and Day 5 (3 hours post last wash procedure)
Change From Baseline in Skin Moisturisation at Day 5
Corneometry was used to measure moisture content of stratum corneum using corneometer. The measuring principle was based on changes in the capacitance of the measuring head, functioning as a condensator. Between the gold conductors of the probe an electrical field was built which allowed the dielectricity of the stratum corneum to be measured. Because the dielectricity of the skin varies as a function of its water content, the stratum corneum moisturisation can be measured. The Corneometer probe was placed in contact with the skin of the paarticipant's test site for 1-2 seconds per measurement. The Corneometer measurements were taken and an average (mean) reading was calculated for each site and time point. Corneometer values lower than 30 instrumental units (i.u.) represents very dry skin, while values between 30 und 50 i.u are typically for dry skin on the forearm. An increase in Corneometer values, therefore, corresponds to a skin-moisturising effect.
Measured: At Baseline and Day 5 (3 hours post last wash procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study start8 May 2017
- Primary completion26 May 2017
- Study completion26 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Skin CareStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKlineGSK Clinical Trials, Study director, GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03119688
- Sponsor's protocol ID
- 207619
- Status last verified
- Jan 2019
- First submitted
- 5 Apr 2017
- Last updated
- 2 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Assess the Mildness of a Cosmetic Cleanser in Healthy Subjects Using the Forearm-Controlled Application Technique (FCAT)
- ClinicalTrials.gov ID
- NCT03119688
- Acronym / sponsor ID
- 207619
- Conditions
- Skin Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 8 May 2017 (actual)
- Primary completion
- 26 May 2017 (actual)
- Study completion
- 26 May 2017 (actual)
- First posted
- 18 Apr 2017 (actual)
- Results
- Posted 2 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this clinical study is to assess the relative mildness of a cosmetic facial cleanser in comparison to water through repeated application to the volar forearm using the FCAT wash procedure.
Detailed description
This is a test site randomized, examiner blinded, positive and negative-controlled, single-center; Forearm Controlled Application Technique clinical study in healthy participants to assess the mildness potential of a cosmetic facial cleansing product.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Test product | Other | Other: Test Product0.09 milliliters (ml) of the cleanser (test product) will be applied on the allocated site on forearm topically. |
| Positive Control | Other | Other: Positive ControlSoap bar (positive control) will be applied on the allocated site on forearm by topical dermal administration of towel moistened with sterile water that had been rubbed onto the 100 g bar of soap for 6 seconds to generate a lather. |
| Negative Control | Other | Other: Reference Product0.09 ml of sterile water (Reference Product) will be applied on the allocated site on forearm topically. |
| No Treatment | Other | Other: No TreatmentAn area of the forearm that remained unwashed and was included in the study as a reference for the treated areas. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
- Aged between 18 and 65 years inclusive.
- Good general and mental health with, in the opinion of the investigator or medically qualified designee no clinically significant and relevant abnormalities in medical history or upon physical examination.
- Intact skin at the proposed application site; volar forearm.
- Clinical assessment for eligibility by a dermatologist to ensure participant is free of clinically relevant dermatological conditions.
Key exclusion criteria (26 listed)
- Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.
- Women who are breast-feeding
- Any history of significant dermatological diseases or conditions or medical conditions known to alter skin appearance or physiologic response (e.g. diabetes,) which could, in the opinion of the Investigator, preclude topical application of the investigational products and/or interfere with the evaluation of the test site reaction.
- Presence of open sores, pimples, or cysts at the application site.
- Active dermatosis (local or disseminated) that might interfere with the results of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Test ProductMicellar cleanser (0.09 ml) | Other | Test product |
| Positive ControlBar Soap (rubbed for 6 seconds to generate a lather) | Other | Positive Control |
| Reference ProductSterile Water (0.09 ml) | Other | Negative Control |
| No TreatmentUnwashed area of the forearm | Other | No Treatment |
Primary outcome
Change From Baseline in Visual Assessment of Dryness at Day 5
Time frame: At Baseline and Day 5 (3 hours post last wash procedure)
Skin dryness was assessed by a trained examiner according to following the scoring scale: 0 (No dryness); 1 (Patches of slight powederiness and occasional patches of small scales may be seen, distribution generalized.); 2 (Generalised slight powederiness, early cracking or occasional small lifting scales may be present); 3 (Generalised moderate powederiness and/or heavy cracking and lifting scales; 4 (Generalised heavy powederiness and/or heavy cracking and lifting scales); 5 (Generalised high cracking and lifting scales, eczematous change may be present, powederiness may be present but not prominent, may see bleeding crack); 6 (Generalised severe cracking, eczematous change may be present, bleeding cracks may be present, scale large may be beginning to disappear). Lower scores reflect less dry skin.
5 secondary outcomes
Change From Baseline in Visual Assessment of Redness at Day 5
Time frame: At Baseline and Day 5 (3 hours post last wash procedure)
Change From Baseline in Visual Assessment of Dryness at Day 2, 3, and 4
Time frame: At Baseline and Day 2, 3, and 4 (3 hours post last wash procedure)
Change From Baseline in Visual Assessment of Redness at Day 2, 3, and 4
Time frame: At Baseline and Day 2, 3, and 4 (3 hours post last wash procedure)
Change From Baseline in Transepidermal Water Loss (TEWL) at Day 5
Time frame: At Baseline and Day 5 (3 hours post last wash procedure)
Change From Baseline in Skin Moisturisation at Day 5
Time frame: At Baseline and Day 5 (3 hours post last wash procedure)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
GSK Clinical Trials study director
GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test Product, Reference Product and No Treatment in people with Skin Care, run by GlaxoSmithKline at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Visual Assessment of Dryness at Day 5 (time frame: At Baseline and Day 5 (3 hours post last wash procedure)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2019.