Skin CareNCT03172364
To Investigate the Cutaneous and Ocular Local Tolerance of Two Cosmetic Facial Cleanser in Healthy Females With Sensitive Skin
A study testing Micellar cleanser and Micellar foaming cleanser 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 cutaneous and ocular local tolerance of two cosmetic facial cleansers in healthy female participants with sensitive skin under normal conditions of use. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Skin Care
- What is being tested?
- Micellar cleanser and Micellar foaming cleanser
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 2 sitesBrazil
- Study dates
- 12 Jun 2017to 13 Jul 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
- Women only
- 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
- 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 (dermatologist or ophthalmologist) examination
- Fitzpatrick phototype I to IV
- Sensitive Skin (as determined by the lactic acid Stinging test)
- Dermatologist score of zero
- Ophthalmologist score of zero
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- Dermatologist assessed Dry or Normal/Combination Skin
- Agreement to comply with the procedures and requirements of the study and to attend the scheduled assessment visits
- Frequent use of facial cosmetic make-up, including eye-make-up (5 out of 7 days per week)
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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- 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 up to 2 weeks before screening visit and during the study
- Oral or topical treatment with vitamin A acid and/or its derivatives up to 1 month before the screening visit and during the study
- 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 Screening visit, or expects to begin injections during study participation
- Previous history of atopy with regards to 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
- Any participant who, in the judgment of the Investigator, should not participate in the study
- Any participant with corneal ulcers, keratoconus, blepharitis, meibomitis, pterygium, chemosis, moderately or severe hyperemia or other active ocular diseases
- Any skin marks on the face 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
- Participant with a qualified dermatologist assessment of oily skin
- 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 Cutaneous and Ocular Local Tolerance of Two Cosmetic Facial Cleansers in Healthy Females With Sensitive Skin Under Normal Conditions of Use
The objective of this clinical study is to assess the cutaneous and ocular local tolerance of two cosmetic facial cleansers in healthy female participants with sensitive skin under normal conditions of use.
Read the detailed description
This is an assessor blind (dermatologist and ophthalmologist) clinical in use study to determine the local cutaneous and ocular tolerance of two cosmetic facial cleanser products when used as per the intended instructions for use in a population of healthy female participants with clinically assessed sensitive skin.
- Conditions
- Skin Care
- Being tested
- Micellar cleanser, Micellar foaming cleanser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micellar cleanserOther
Participants will apply the micellar cleanser topically twice a day (morning and evening). Micellar cleanser will be applied on cotton pad and wiped over the entire face and closed eye to gently cleanse. No need to rub or rinse the micellar cleanser.
Micellar foaming cleanserOther
Participants will use the micellar foaming cleanser topically twice a day (morning and evening). Micellar foaming cleanser will be massaged gently onto wet skin on the face using fingertips. After which participants will rinse thoroughly and pat the skin dry.
| Study group | Role | What they receive |
|---|---|---|
| Test product 1 | Experimental | All the participants in this arm will receive test product 1 (micellar cleanser) at home twice a day (morning and evening) for 21 (±2) days. Receives: Other: Micellar cleanser |
| Test product 2 | Experimental | All the participants in this arm will receive test product 2 (micellar foaming cleanser) at home twice a day (morning and evening) for 21 (±2) days. Receives: Other: Micellar foaming cleanser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Combined Dermatologist Score
The intensity of any visual signs of irritation was recorded according to Dermal response score: 0=No evidence of irritation, 1=Minimal erythema; barely perceptible, 2=Definite erythema, readily visible; or minimal edema; or minimal popular response, 3=Erythema and papules, 4=Definite edema, 5=Erythema, edema, and papules, 6=Vesicular eruption, and 7=Strong reaction spreading beyond test site. Dermatologist also provided a superficial irritation score if the dermal response score >0. Superficial irritation score was as follow: grade A/score 0=Slight glazed appearance, grade B/score 1=Marked glazing, grade C/score 2=Glazing with peeling and cracking, grade F/score 3=Glazing with fissures, grade G/score 3=Film of dried serous exudate covering all or portion of the patch, and grade H/score 3=Small petechial erosions and/or scabs. The combined score was equal the sum of the dermal response score plus the numerical equivalent of the superficial irritation score. Full range 0-10.
Measured: After 21 (+2) days of test product use
Frequency of Combined Ophthalmologist Score
Ocular irritation assessed through the observation of the presence of two factors: Lacrimation Intensity and Conjunctiva Involvement. Conjunctiva involvement score are as follow: 0= None - No involvement, 1= Mild - Conjunctivae (palpebral and bulbar) injected above normal with possible chemosis (swelling); no discharge, 2= Moderate - Conjunctivae injected above normal; obvious swelling; possible discharge, and 3= Severe - Conjunctivae more diffuse, deeper crimson red, individual vessels not easily discernible; excessive swelling and/or discharge. Lacrimal intensity score are as follow: 0= None - No lacrimation observed, 1= Mild-Excessive wetness (no distinct tears), 2= Moderate - A few formed tears (contained in orbit), and 3= Severe - Intense tearing (leaving orbit). The combined ophthalmologist score was calculated in the following way: Combined ophthalmologist score = conjunctiva involvement score + lacrimal intensity score. Full range 0-6.
Measured: After 21 (+2) days of test product use
Frequency of Combined Dermatologist and Ophthalmologist Score
The combined dermatologist and ophthalmologist score was calculated as the sum of the combined dermatologist score (i.e., dermal response score + superficial irritation score) and the combined ophthalmologist score (i.e., conjunctiva involvement score + lacrimal intensity score). No inferential statistic were performed for this endpoint.The full range was from 0 to 13 where lower scores indicated lower dermal irritation.
Measured: After 21 (+2) days of test product use
Combined Dermatologist and Ophthalmologist Score (Modified)
A modified combined dermatologist and ophthalmologist score was calculated, where the superficial irritation component was removed from the equation. Therefore, the modified combined dermatologist and ophthalmologist score was defined as the dermal response score + the combined ophthalmologist score (i.e., conjunctiva involvement score + lacrimal intensity score). No inferential statistic were performed for this endpoint.The full range was from 0 to 13 where lower scores indicated lower dermal irritation.
Measured: After 21 (+2) days of test product use
Secondary outcomes (2)
Frequency of Participant Self-assessment Combined Score for Question Responses With Regards to Product Use Experience on Face
Participants asked Subject Self-Assessment questions at Baseline (Visit 2), prior to test product use, 1 hour (± 20 minutes) following first supervised product use, and following 21 (+2) days of product use. Participants scored each symptom asked in the question (Are you experiencing any redness, dryness, burning, itching or stinging of your face?) by using following score: 0= None, 1=Mild, 2= Moderate, and 3= Severe. Combined score face was obtained by summing the 5 subject assessments for face i.e. redness, dryness, burning, itching and stinging. Maximum observed value of this combined score was 3 and maximum possible combined score was 15. Minimum observed value of this combined score was 0 and minimum possible combined score was 0.
Measured: Baseline and after 21 (+2) days of test product use
Frequency of Participant Self-assessment Combined Score for Question Responses With Regards to Product Use Experience on Eye
Participants asked Subject Self-Assessment questions at Baseline (Visit 2), prior to test product use, 1 hour (± 20 minutes) following first supervised product use, and following 21 (+2) days of product use. Participants scored each symptom asked in the question (Are you experiencing any redness, dryness, burning, itching or stinging of your eyes?) by using following score: 0= None, 1=Mild, 2= Moderate, and 3= Severe. Maximum observed value of this combined score was 3 and maximum possible combined score was 15. Minimum observed value of this combined score was 0 and minimum possible combined score was 0.
Measured: Baseline and after 21 (+2) days of test product use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2017
- Study start12 Jun 2017
- Primary completion13 Jul 2017
- Study completion13 Jul 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 122 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
- NCT03172364
- Sponsor's protocol ID
- 207782
- Status last verified
- Mar 2019
- First submitted
- 29 May 2017
- Last updated
- 2 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Assess the Cutaneous and Ocular Local Tolerance of Two Cosmetic Facial Cleansers in Healthy Females With Sensitive Skin Under Normal Conditions of Use
- ClinicalTrials.gov ID
- NCT03172364
- Acronym / sponsor ID
- 207782
- Conditions
- Skin Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 12 Jun 2017 (actual)
- Primary completion
- 13 Jul 2017 (actual)
- Study completion
- 13 Jul 2017 (actual)
- First posted
- 1 Jun 2017 (actual)
- Results
- Posted 2 Apr 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 cutaneous and ocular local tolerance of two cosmetic facial cleansers in healthy female participants with sensitive skin under normal conditions of use.
Detailed description
This is an assessor blind (dermatologist and ophthalmologist) clinical in use study to determine the local cutaneous and ocular tolerance of two cosmetic facial cleanser products when used as per the intended instructions for use in a population of healthy female participants with clinically assessed sensitive skin.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test product 1 | Experimental | Other: Micellar cleanserAll the participants in this arm will receive test product 1 (micellar cleanser) at home twice a day (morning and evening) for 21 (±2) days. |
| Test product 2 | Experimental | Other: Micellar foaming cleanserAll the participants in this arm will receive test product 2 (micellar foaming cleanser) at home twice a day (morning and evening) for 21 (±2) days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 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
- 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 (dermatologist or ophthalmologist) examination
- Fitzpatrick phototype I to IV
- Sensitive Skin (as determined by the lactic acid Stinging test)
- Dermatologist score of zero
Key exclusion criteria (24 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 |
|---|---|---|
| Micellar cleanserParticipants will apply the micellar cleanser topically twice a day (morning and evening). Micellar cleanser will be applied on cotton pad and wiped over the entire face and closed eye to gently cleanse. No need to rub or rinse the micellar cleanser. | Other | Test product 1 |
| Micellar foaming cleanserParticipants will use the micellar foaming cleanser topically twice a day (morning and evening). Micellar foaming cleanser will be massaged gently onto wet skin on the face using fingertips. After which participants will rinse thoroughly and pat the skin dry. | Other | Test product 2 |
Primary outcome
Frequency of Combined Dermatologist Score
Time frame: After 21 (+2) days of test product use
The intensity of any visual signs of irritation was recorded according to Dermal response score: 0=No evidence of irritation, 1=Minimal erythema; barely perceptible, 2=Definite erythema, readily visible; or minimal edema; or minimal popular response, 3=Erythema and papules, 4=Definite edema, 5=Erythema, edema, and papules, 6=Vesicular eruption, and 7=Strong reaction spreading beyond test site. Dermatologist also provided a superficial irritation score if the dermal response score >0. Superficial irritation score was as follow: grade A/score 0=Slight glazed appearance, grade B/score 1=Marked glazing, grade C/score 2=Glazing with peeling and cracking, grade F/score 3=Glazing with fissures, grade G/score 3=Film of dried serous exudate covering all or portion of the patch, and grade H/score 3=Small petechial erosions and/or scabs. The combined score was equal the sum of the dermal response score plus the numerical equivalent of the superficial irritation score. Full range 0-10.
Frequency of Combined Ophthalmologist Score
Time frame: After 21 (+2) days of test product use
Ocular irritation assessed through the observation of the presence of two factors: Lacrimation Intensity and Conjunctiva Involvement. Conjunctiva involvement score are as follow: 0= None - No involvement, 1= Mild - Conjunctivae (palpebral and bulbar) injected above normal with possible chemosis (swelling); no discharge, 2= Moderate - Conjunctivae injected above normal; obvious swelling; possible discharge, and 3= Severe - Conjunctivae more diffuse, deeper crimson red, individual vessels not easily discernible; excessive swelling and/or discharge. Lacrimal intensity score are as follow: 0= None - No lacrimation observed, 1= Mild-Excessive wetness (no distinct tears), 2= Moderate - A few formed tears (contained in orbit), and 3= Severe - Intense tearing (leaving orbit). The combined ophthalmologist score was calculated in the following way: Combined ophthalmologist score = conjunctiva involvement score + lacrimal intensity score. Full range 0-6.
Frequency of Combined Dermatologist and Ophthalmologist Score
Time frame: After 21 (+2) days of test product use
The combined dermatologist and ophthalmologist score was calculated as the sum of the combined dermatologist score (i.e., dermal response score + superficial irritation score) and the combined ophthalmologist score (i.e., conjunctiva involvement score + lacrimal intensity score). No inferential statistic were performed for this endpoint.The full range was from 0 to 13 where lower scores indicated lower dermal irritation.
Combined Dermatologist and Ophthalmologist Score (Modified)
Time frame: After 21 (+2) days of test product use
A modified combined dermatologist and ophthalmologist score was calculated, where the superficial irritation component was removed from the equation. Therefore, the modified combined dermatologist and ophthalmologist score was defined as the dermal response score + the combined ophthalmologist score (i.e., conjunctiva involvement score + lacrimal intensity score). No inferential statistic were performed for this endpoint.The full range was from 0 to 13 where lower scores indicated lower dermal irritation.
2 secondary outcomes
Frequency of Participant Self-assessment Combined Score for Question Responses With Regards to Product Use Experience on Face
Time frame: Baseline and after 21 (+2) days of test product use
Frequency of Participant Self-assessment Combined Score for Question Responses With Regards to Product Use Experience on Eye
Time frame: Baseline and after 21 (+2) days of test product use
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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 Micellar cleanser and Micellar foaming cleanser 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 9 inclusion and 24 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 Apr 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 Apr 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?
Frequency of Combined Dermatologist Score (time frame: After 21 (+2) days of test product use). The study lists 4 primary outcomes in all. 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 Apr 2019.