Skin CareNCT04557371
A Study to Assess the Local Cutaneous and Ocular Tolerance of Three Developmental Facial Skin-care Formulations.
A study testing Serum, Lotion and Cream in people with Skin Care, run by GlaxoSmithKline at 1 site in Germany.
Trial summary
This study aims to determine the local cutaneous and ocular tolerance of 3 developmental skin-care products; a serum, a lotion, and a cream in healthy female subjects with clinically evaluated sensitive facial skin for 21 days. 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?
- Serum, Lotion and Cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- 12 Oct 2020to 22 Dec 2020
- 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
- Participant provision of a signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed.
- A participant who is willing and able to comply with scheduled visits, the application schedule, the lifestyle guidelines, and other study procedures.
- A participant in good general and mental health with, in the opinion of the investigator or medically qualified designee , no clinically significant/relevant abnormalities in medical history or upon dermatologist and ophthalmologist examination, or condition, that would impact the participant's safety, well-being or the outcome of the study, if they were to participate in the study, or affect the individual's ability to understand and follow study procedures and requirements.
- Participants with sensitive facial skin, defined as a positive response to a LAST in the nasolabial area.
- A participant with a dermatologist signs and symptoms of cutaneous irritation score of 0.5 (very slight) or greater for erythema per dermatological evaluation.
- A participant with a dermatologist signs and symptoms of cutaneous irritation score of 0.5 (very slight) or greater for dryness per dermatological evaluation.
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- A participant with a dermatologist signs and symptoms of cutaneous irritation score of 0 (none) or 0.5 (very sight) for scaling per dermatological evaluation.
- A participant with a dermatologist signs and symptoms of cutaneous irritation score of 0 (none) or 0.5 (very sight) for edema per dermatological evaluation.
- A participant with an ophthalmologist total signs and symptoms of ocular irritation score of zero (0) per dermatological evaluation.
Who cannot join
- A participant who is an employee of the investigational site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the investigational site otherwise supervised by the investigator; or, a GSK CH employee directly involved in the conduct of the study or a member of their immediate family.
- A participant who has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days prior to study entry and/or during study participation.
- A participant who is pregnant (self-reported) or intends to become pregnant during the study duration.
- A participant who is breastfeeding.
- A participant with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
- A participant unwilling or unable to comply with the protocol lifestyle considerations required by this study, as described in this protocol.
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- A participant with current or recent (within last 6 months before the start of the study) history of atopic lesions and/or eczema.
- A participant with a history of allergic reactions to topical-use products, cosmetics or medications or their ingredients.
- A participant with any history of significant diseases or medical conditions known to alter skin or eye 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.
- A participant presenting open sores, pimples, or cysts at the application site (face).
- A participant considered immune-compromised.
- A participant who has used any of the following topical or systemic medications up to two weeks before the screening visit: immuno-suppressants, antihistamines, non-steroidal anti-inflammatory drugs (NSAIDS), and/or corticosteroids.
- A participant who has used oral or topical treatment with vitamin A acid and/or its derivatives up to 1 month before the screening visit.
- A participant who has been vaccinated up to 1 month before the screening visit or who is intending to receive a vaccination during their participation in the study.
- A participant with a recent history (within the last 5 years) of alcohol or other substance abuse.
- A participant with 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).
- A participant who has previously been enrolled in this study.
- A participant with, in the opinion of the investigator or medically qualified designee, an acute or chronic medical or psychiatric condition that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator or medically qualified designee, would make the participant inappropriate for entry into this study.
- Participants with corneal ulcers, keratoconus, blepharitis, meibomitis, pterygium, chemosis, moderately or severe hyperaemia or other active ocular diseases.
- A participant currently using any medication which in the opinion of the investigator (medically qualified designee) may affect the evaluation of the investigational product or place the participant at undue risk.
- A participant with an active dermatosis (local or disseminated) that might interfere with the results of the study.
- A participant with a dermatologist signs and symptoms of cutaneous irritation score of 3 (severe) for edema, scaling, erythema, or dryness per dermatological evaluation.
- A participant who, in the opinion of the investigator or medically qualified designee, should not participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Study to Assess the Local Cutaneous and Ocular Tolerance of Three Developmental Cosmetic Facial Skin Care Formulations in Healthy Females With Clinically Assessed Sensitive Skin.
This study aims to determine the local cutaneous and ocular tolerance of 3 developmental skin-care products; a serum, a lotion, and a cream in healthy female subjects with clinically evaluated sensitive facial skin for 21 days.
Read the detailed description
This will be a randomized, non-comparative, single-blind (evaluator), 3-arm, parallel-group, single-center, clinical 'in-use' study to determine the local cutaneous and ocular tolerance profiles of 3 developmental cosmetic facial skincare products; a serum, lotion, and cream in healthy females with clinically-evaluated sensitive skin as determined by a positive response to a Lactic Acid Stinging Test (LAST) with signs or symptoms of cutaneous irritation and no ophthalmological conditions. Assessments will be performed and recorded for 21 days.
- Conditions
- Skin Care
- Being tested
- Serum, Lotion, Cream
- Keywords
- Glycerol, Niacinamide, Skin Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SerumOther
Participants will topically apply the serum to the face as per normal home use application in place of their current facial serum product.
LotionOther
Participants will topically apply lotion to the face as per normal home use application in place of their current facial lotion product.
CreamOther
Participants will topically apply cream to the face as per normal home use application in place of their current facial cream product.
| Study group | Role | What they receive |
|---|---|---|
| Developmental Serum | Experimental | The participants will apply a developmental serum topically to the face twice daily (morning and evening) to freshly cleansed with normal moisturizing routine for 21 days. Receives: Other: Serum |
| Developmental Lotion | Experimental | The participants will apply a developmental lotion topically to the face twice daily (morning and evening) to freshly cleansed skin for 21 days. Receives: Other: Lotion |
| Developmental Cream | Experimental | The participants will apply a developmental cream topically to the face twice daily (morning and evening) to freshly cleansed skin for 21 days. Receives: Other: Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Determined by a Dermatologist to Have a Clinically Relevant Positive Outcome for Cutaneous Irritation After 21 Days of Product Use
The clinically relevant positive outcome for cutaneous irritation was defined as the number of participants who experienced an increase in total cutaneous irritation score at Day 21 versus Baseline that was deemed clinically-relevant by the examiner. The dermatologist assessment of signs and symptoms of cutaneous irritation total score was calculated as the sum of the individual cutaneous response attributes (erythema, dryness, scaling, and edema). Each attribute was assessed on a scale with a score range of 0 to 3, where 0=none, 0.5=very slight, 1=slight, 2=moderate, 3=severe. Total possible score range was 0 to 12 where higher value indicated more cutaneous irritation.
Measured: Day 21
Secondary outcomes (5)
Number of Participants Determined by an Ophthalmologist to Have a Clinically Relevant Positive Outcome for Ocular Irritation After 21 Days of Product Use
The clinically relevant positive outcome for ocular irritation was defined as the number of participants who experienced an increase in total ocular irritation score at Day 21 versus Baseline that was deemed clinically-relevant by the examiner. The ophthalmologist assessment of signs and symptoms of ocular irritation total score was calculated as the sum of the individual ocular response attributes (eczema of the eyelid, conjunctivitis, follicles, and chemosis conjunctivae). Each attribute was assessed on a scale with a score range of 0 to 3, where 0=none, 0.5=very slight, 1=slight, 2=moderate, 3=severe. Total possible score range was 0 to 12 where higher value indicated the most severe condition.
Measured: Day 21
Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application
Participants were asked to self-assess any sensations of cutaneous discomfort for redness, dryness, stinging/burning, itching, and tightness each on separate 0-3 scale, where 0=none, 0.5=very slight, 1=slight, 2=moderate, 3=severe. These 5 separate assessments were summed to give an overall self-assessed total signs and symptoms of cutaneous irritation score ranging from 0-15. A high score indicates the most severe condition. Change from Baseline in total score at 1 to 2 hours = total cutaneous score at 1 to 2 hours minus total cutaneous score at Baseline. Negative values reflect improvement; a decrease in total score versus Baseline. This reflects a reduction in total signs and symptoms of cutaneous irritation versus Baseline. Positive values reflect worsening; an increase in total score versus Baseline. This reflects an increase in total signs and symptoms of cutaneous irritation versus Baseline. A zero change reflects no change in total score.
Measured: Baseline and 1 to 2 hours post first use
Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use
Participants were asked to self-assess any sensations of cutaneous discomfort for redness, dryness, stinging/burning, itching, and tightness each on separate 0-3 scale, where 0=none, 0.5=very slight, 1=slight, 2=moderate, 3=severe. These 5 separate assessments were summed to give an overall self-assessed total signs and symptoms of cutaneous irritation score ranging from 0-15. A high score indicates the most severe condition. Change from Baseline in total score at Day 21 = total cutaneous score at Day 21 minus total cutaneous score at Baseline. Negative values reflect improvement; a decrease in total score versus Baseline. This reflects a reduction in total signs and symptoms of cutaneous irritation versus Baseline. Positive values reflect worsening; an increase in total score versus Baseline. This reflects an increase in total signs and symptoms of cutaneous irritation versus Baseline. A zero change reflects no change in total score.
Measured: Baseline and Day 21
Change From Baseline Prior to Any Product Application) in Participants Self-Assessment Scores of Signs and Symptoms of Ocular Irritation 1 to 2 Hours After First Product Application
Participants were asked to self-assess any sensations of ocular discomfort for redness, dryness, stinging/burning, and itching each on separate 0-3 scale, where 0=none, 0.5=very slight, 1=slight, 2=moderate, 3=severe. These 5 separate assessments were summed to give an overall self-assessed total signs and symptoms of ocular discomfort score ranging from 0-12. A high score indicates the most severe condition. Change from Baseline in total score at 1 to 2 hours = total ocular score at 1 to 2 hours minus total ocular score at Baseline. Negative values reflect improvement; a decrease in total score versus Baseline. This reflects a reduction in total signs and symptoms of ocular irritation versus Baseline. Positive values reflect worsening; an increase in total score versus Baseline. This reflects an increase in total signs and symptoms of ocular irritation versus Baseline. A zero change reflects no change in total score.
Measured: Baseline and 1 to 2 hours post first use
Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Ocular Irritation After 21 Days of Product Use
Participants were asked to self-assess any sensations of ocular discomfort for redness, dryness, stinging/burning, and itching each on separate 0-3 scale, where 0=none, 0.5=very slight, 1=slight, 2=moderate, 3=severe. These 5 separate assessments were summed to give an overall self-assessed total signs and symptoms of ocular discomfort score ranging from 0-12. A high score indicates the most severe condition. Change from Baseline in total score at Day 21 = total ocular score at Day 21 minus total ocular score at Baseline. Negative values reflect improvement; a decrease in total score versus Baseline. This reflects a reduction in total signs and symptoms of ocular irritation versus Baseline. Positive values reflect worsening; an increase in total score versus Baseline. This reflects an increase in total signs and symptoms of ocular irritation versus Baseline. A zero change reflects no change in total score.
Measured: Baseline and Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2020
- Study start12 Oct 2020
- Primary completion22 Dec 2020
- Study completion22 Dec 2020
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is a randomized, 3-arm parallel group study.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04557371
- Sponsor's protocol ID
- 213059
- Status last verified
- Feb 2022
- First submitted
- 15 Sep 2020
- Last updated
- 22 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD for this study will be made available via the Clinical Study Data Request site.
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Assess the Local Cutaneous and Ocular Tolerance of Three Developmental Cosmetic Facial Skin Care Formulations in Healthy Females With Clinically Assessed Sensitive Skin.
- ClinicalTrials.gov ID
- NCT04557371
- Acronym / sponsor ID
- 213059
- Conditions
- Skin Care
- Keywords
- Glycerol, Niacinamide, Skin Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 12 Oct 2020 (actual)
- Primary completion
- 22 Dec 2020 (actual)
- Study completion
- 22 Dec 2020 (actual)
- First posted
- 21 Sep 2020 (actual)
- Results
- Posted 22 Apr 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to determine the local cutaneous and ocular tolerance of 3 developmental skin-care products; a serum, a lotion, and a cream in healthy female subjects with clinically evaluated sensitive facial skin for 21 days.
Detailed description
This will be a randomized, non-comparative, single-blind (evaluator), 3-arm, parallel-group, single-center, clinical 'in-use' study to determine the local cutaneous and ocular tolerance profiles of 3 developmental cosmetic facial skincare products; a serum, lotion, and cream in healthy females with clinically-evaluated sensitive skin as determined by a positive response to a Lactic Acid Stinging Test (LAST) with signs or symptoms of cutaneous irritation and no ophthalmological conditions. Assessments will be performed and recorded for 21 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- The study is a randomized, 3-arm parallel group study.
| Arm | Type | Receives |
|---|---|---|
| Developmental Serum | Experimental | Other: SerumThe participants will apply a developmental serum topically to the face twice daily (morning and evening) to freshly cleansed with normal moisturizing routine for 21 days. |
| Developmental Lotion | Experimental | Other: LotionThe participants will apply a developmental lotion topically to the face twice daily (morning and evening) to freshly cleansed skin for 21 days. |
| Developmental Cream | Experimental | Other: CreamThe participants will apply a developmental cream topically to the face twice daily (morning and evening) to freshly cleansed skin for 21 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)
- Participant provision of a signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed.
- A participant who is willing and able to comply with scheduled visits, the application schedule, the lifestyle guidelines, and other study procedures.
- A participant in good general and mental health with, in the opinion of the investigator or medically qualified designee , no clinically significant/relevant abnormalities in medical history or upon dermatologist and ophthalmologist examination, or condition, that would impact the participant's safety, well-being or the outcome of the study, if they were to participate in the study, or affect the individual's ability to understand and follow study procedures and requirements.
- Participants with sensitive facial skin, defined as a positive response to a LAST in the nasolabial area.
- A participant with a dermatologist signs and symptoms of cutaneous irritation score of 0.5 (very slight) or greater for erythema per dermatological evaluation.
Key exclusion criteria (23 listed)
- A participant who is an employee of the investigational site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the investigational site otherwise supervised by the investigator; or, a GSK CH employee directly involved in the conduct of the study or a member of their immediate family.
- A participant who has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days prior to study entry and/or during study participation.
- A participant who is pregnant (self-reported) or intends to become pregnant during the study duration.
- A participant who is breastfeeding.
- A participant with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
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 |
|---|---|---|
| SerumParticipants will topically apply the serum to the face as per normal home use application in place of their current facial serum product. | Other | Developmental Serum |
| LotionParticipants will topically apply lotion to the face as per normal home use application in place of their current facial lotion product. | Other | Developmental Lotion |
| CreamParticipants will topically apply cream to the face as per normal home use application in place of their current facial cream product. | Other | Developmental Cream |
Primary outcome
Number of Participants Determined by a Dermatologist to Have a Clinically Relevant Positive Outcome for Cutaneous Irritation After 21 Days of Product Use
Time frame: Day 21
The clinically relevant positive outcome for cutaneous irritation was defined as the number of participants who experienced an increase in total cutaneous irritation score at Day 21 versus Baseline that was deemed clinically-relevant by the examiner. The dermatologist assessment of signs and symptoms of cutaneous irritation total score was calculated as the sum of the individual cutaneous response attributes (erythema, dryness, scaling, and edema). Each attribute was assessed on a scale with a score range of 0 to 3, where 0=none, 0.5=very slight, 1=slight, 2=moderate, 3=severe. Total possible score range was 0 to 12 where higher value indicated more cutaneous irritation.
5 secondary outcomes
Number of Participants Determined by an Ophthalmologist to Have a Clinically Relevant Positive Outcome for Ocular Irritation After 21 Days of Product Use
Time frame: Day 21
Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation 1 to 2 Hours After First Product Application
Time frame: Baseline and 1 to 2 hours post first use
Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Cutaneous Irritation After 21 Days of Product Use
Time frame: Baseline and Day 21
Change From Baseline Prior to Any Product Application) in Participants Self-Assessment Scores of Signs and Symptoms of Ocular Irritation 1 to 2 Hours After First Product Application
Time frame: Baseline and 1 to 2 hours post first use
Change From Baseline (Prior to Any Product Application) in Participant Self-Assessment Scores of Signs and Symptoms of Ocular Irritation After 21 Days of Product Use
Time frame: Baseline and Day 21
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.
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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 (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serum, Lotion and Cream in people with Skin Care, run by GlaxoSmithKline at 1 site in Germany.
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 23 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 22 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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 22 Apr 2022). 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?
Number of Participants Determined by a Dermatologist to Have a Clinically Relevant Positive Outcome for Cutaneous Irritation After 21 Days of Product Use (time frame: Day 21). 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 22 Apr 2022.