Skin CareNCT03233009

To Investigate Primary Irritation Potential of Four Skin Serum Products on Human Subjects Assessed by 24 Hour Patch Test

A study testing Experimental Daily Defense Serum A, Experimental Daily Defense Serum C and Experimental Daily Defense Serum G in people with Skin Care, run by GlaxoSmithKline at 2 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

To assess the irritation potential of four prototype daily defense serum formulations after 24 (± 2) hours under semi-occlusive patch application to the skin of healthy volunteers. 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?: Experimental Daily Defense Serum A, Experimental Daily Defense Serum C and Experimental Daily Defense Serum G
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 43 participants
Where: 2 sitesBrazil
Study dates: 22 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.
General health: 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 and participants must have intact skin on the proposed application site; dorsum (scapular region).
Fitzpatrick photo type I to IV.
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.

Show all 25Show fewer

History of diseases aggravated or triggered by ultraviolet radiation.
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.
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 vaccination within 3 weeks of the Screening visit.
Currently receiving allergy injections, or due to receive an 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 any of the study materials (or closely related compounds) or any of their stated ingredients, including any component of the patches.
History of sensitization in a previous patch study.
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 up to 30 days before the Screening evaluation Intention of bathing, sauna, water sports, or activities that lead to intense sweating.
Any participant who, in the judgment of the Investigator, 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
Valinhos, 13271-130
GSK Investigational Site
Valinhos, 13271-

Other trials in Brazil

About this study

Official title: A Human Subject 24 Hour Patch Test to Assess the Irritation Potential of Four Skin Serum Products

To assess the irritation potential of four prototype daily defense serum formulations after 24 (± 2) hours under semi-occlusive patch application to the skin of healthy volunteers.

Read the detailed description

This is an evaluator (single) blind, test site randomized and intra-subject comparison patch test study to evaluate the cutaneous irritation potential of four experimental daily defense serum formulations, including a saline solution as a negative control.

Conditions: Skin Care
Being tested: Experimental Daily Defense Serum A, Experimental Daily Defense Serum C, Experimental Daily Defense Serum G, Experimental Daily Defense Serum N, Saline Solution Sodium Chloride

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Experimental Daily Defense Serum AOther
Participants will apply 0.02mL/cm2 of product topically via semi-occlusive patches onto dorsum (Scapular region).
Experimental Daily Defense Serum COther
Participants will apply 0.02mL/cm2 of product topically via semi-occlusive patches onto dorsum (Scapular region).
Experimental Daily Defense Serum GOther
Participants will apply 0.02mL/cm2 of product topically via semi-occlusive patches onto dorsum (Scapular region).
Experimental Daily Defense Serum NOther
Participants will apply 0.02mL/cm2 of product topically via semi-occlusive patches onto dorsum (Scapular region).
Saline Solution Sodium ChlorideOther
Participants will apply 0.02mL/cm2 of product topically via semi-occlusive patches onto dorsum (Scapular region).

Study groups in NCT03233009
Study group	Role	What they receive
Test Product 1	Experimental	Participants will topically apply test product 1 via semi occlusive patch. Receives: Other: Experimental Daily Defense Serum A
Test Product 2	Experimental	Participants will topically apply test product 2 via semi occlusive patch. Receives: Other: Experimental Daily Defense Serum C
Test Product 3	Experimental	Participants will topically apply test product 3 via semi occlusive patch. Receives: Other: Experimental Daily Defense Serum G
Test Product 4	Experimental	Participants will topically apply test product 4 via semi occlusive patch. Receives: Other: Experimental Daily Defense Serum N
Reference Product	Sham comparator	Participants will topically apply Reference product via semi occlusive patch. Receives: Other: Saline Solution Sodium Chloride

What is being measured

The primary outcome is the main question the study is designed to answer.

Frequency of Dermal Response Score at 15-30 Minutes Post Patch Removal
Product tolerability was assessed by Dermal Response Score. Test sites were evaluated 15-30 minutes following patch removal on Day 2 post 24 hrs of patch application. Response score from 0 to 7; 0= No evidence of irritation, 1= Minimal erythema, barely perceptible, 2= Definite erythema, readily visible; minimal edema or minimal papular response, 3= Erythema and papules, 4= Definite edema, 5= Erythema, edema and papules, 6= Vesicular eruption, 7= Strong reaction spreading beyond test site.
Measured: At Day 2 (15-30 minutes post patch removal)
Frequency of Dermal Response Score at 24 Hours Post Patch Removal
Product tolerability was assessed by Dermal Response Score. Test sites were evaluated 24 hours following patch removal on Day 3 post 48 hrs of patch application. Response score from 0 to 7; 0= No evidence of irritation, 1= Minimal erythema, barely perceptible, 2= Definite erythema, readily visible; minimal edema or minimal papular response, 3= Erythema and papules, 4= Definite edema, 5= Erythema, edema and papules, 6= Vesicular eruption, 7= Strong reaction spreading beyond test site.
Measured: At Day 3 (24 hours post patch removal)
Frequency of Dermal Response Score at 48 Hours Post Patch Removal
Product tolerability was assessed by Dermal Response Score. Test sites were evaluated 48 hours following patch removal on Day 4 post 72 hours of patch application. Response score from 0 to 7; 0= No evidence of irritation, 1= Minimal erythema, barely perceptible, 2= Definite erythema, readily visible; minimal edema or minimal papular response, 3= Erythema and papules, 4= Definite edema, 5= Erythema, edema and papules, 6= Vesicular eruption, 7= Strong reaction spreading beyond test site.
Measured: At Day 4 (48 hours post patch removal)
Average Dermal Response Score at 30 Minutes Post Patch Removal
Product tolerability was assessed by Dermal Response Score. Test sites were evaluated 15-30 minutes following patch removal on Day 2 post 24 hours of patch application. Response score from 0 to 7; 0= No evidence of irritation, 1= Minimal erythema, barely perceptible, 2= Definite erythema, readily visible; minimal edema or minimal papular response, 3= Erythema and papules, 4= Definite edema, 5= Erythema, edema and papules, 6= Vesicular eruption, 7= Strong reaction spreading beyond test site.
Measured: At Day 2 (15-30 minutes post patch removal)
Average Dermal Response Score at 24 Hours Post Patch Removal
Product tolerability was assessed by Dermal Response Score. Test sites were evaluated 24 hours following patch removal on Day 3 post 48 hours of patch application. Response score from 0 to 7; 0= No evidence of irritation, 1= Minimal erythema, barely perceptible, 2= Definite erythema, readily visible; minimal edema or minimal papular response, 3= Erythema and papules, 4= Definite edema, 5= Erythema, edema and papules, 6= Vesicular eruption, 7= Strong reaction spreading beyond test site.
Measured: At Day 3 (24 hours post patch removal)
Average Dermal Response Score at 48 Hours Post Patch Removal
Product tolerability was assessed by Dermal Response Score. Test sites were evaluated 48 hours following patch removal on Day 4 post 72 hours of patch application. Response score from 0 to 7; 0= No evidence of irritation, 1= Minimal erythema, barely perceptible, 2= Definite erythema, readily visible; minimal edema or minimal papular response, 3= Erythema and papules, 4= Definite edema, 5= Erythema, edema and papules, 6= Vesicular eruption, 7= Strong reaction spreading beyond test site.
Measured: At Day 4 (48 hours post patch removal)

Secondary outcomes (1)

Number of Participants With Combined Skin Irritation (Dermal Response) Scores at 30 Minutes, 24 Hours and 48 Hours Post Patch Removal
A trained assessor assessed all patch sites.Following scores were used to express response observed at time of examination:0=No evidence of irritation,1=Minimal erythema;barely perceptible,2=Definite erythema,readily visible;or minimal edema; or minimal papular response,3=Erythema and papules,4=Definite edema,5=Erythema, edema,and papules,6=Vesicular eruption,7=Strong reaction spreading beyond test site.Other features indicative irritation (Superficial irritation) scores were:GradeA/Score0=Slight glazed appearance,GradeB/Score1=Marked glazing,GradeC/Score2=Glazing with peeling and cracking,GradeF/Score3=Glazing with fissures,Grade G/Score 3=Film of dried serous exudate covering all or portion of patch,Grade H/Score3=Small petechial erosions and/or scabs.The letter grades were converted to scores.Superficial irritation scores were only provided if there was a dermal response score >0.No effect is 0 score(i.e. no evidence).Full Range 0-10.Lower score indicates better product tolerabily
Measured: At Day 2 (15-30 minutes), Day 3 (24 hours) and Day 4 (48 hours) post patch removal

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 May 201726 May 2017

First posted28 Jul 2017
Study start22 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: Single blind
Who is masked: Outcomes assessor
Enrolment: 43 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03233009
Sponsor's protocol ID: 207235
Status last verified: Dec 2018
First submitted: 7 Jul 2017
Last updated: 16 Jan 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Human Subject 24 Hour Patch Test to Assess the Irritation Potential of Four Skin Serum Products
ClinicalTrials.gov ID: NCT03233009
Acronym / sponsor ID: 207235
Conditions: Skin Care
Study type: Interventional
Recruitment status: Completed
Enrolment: 43 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 22 May 2017 (actual)
Primary completion: 26 May 2017 (actual)
Study completion: 26 May 2017 (actual)
First posted: 28 Jul 2017 (actual)
Results: Posted 7 Sep 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To assess the irritation potential of four prototype daily defense serum formulations after 24 (± 2) hours under semi-occlusive patch application to the skin of healthy volunteers.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 5

Arm	Type	Receives
Test Product 1	Experimental	Other: Experimental Daily Defense Serum AParticipants will topically apply test product 1 via semi occlusive patch.
Test Product 2	Experimental	Other: Experimental Daily Defense Serum CParticipants will topically apply test product 2 via semi occlusive patch.
Test Product 3	Experimental	Other: Experimental Daily Defense Serum GParticipants will topically apply test product 3 via semi occlusive patch.
Test Product 4	Experimental	Other: Experimental Daily Defense Serum NParticipants will topically apply test product 4 via semi occlusive patch.
Reference Product	Sham comparator	Other: Saline Solution Sodium ChlorideParticipants will topically apply Reference product via semi occlusive patch.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 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.
General health: 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 and participants must have intact skin on the proposed application site; dorsum (scapular region).
Fitzpatrick photo type I to IV.
Agreement to comply with the procedures and requirements of the study and to attend the scheduled assessment visits.

Key exclusion criteria (25 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
Experimental Daily Defense Serum AParticipants will apply 0.02mL/cm2 of product topically via semi-occlusive patches onto dorsum (Scapular region).	Other	Test Product 1
Experimental Daily Defense Serum CParticipants will apply 0.02mL/cm2 of product topically via semi-occlusive patches onto dorsum (Scapular region).	Other	Test Product 2
Experimental Daily Defense Serum GParticipants will apply 0.02mL/cm2 of product topically via semi-occlusive patches onto dorsum (Scapular region).	Other	Test Product 3
Experimental Daily Defense Serum NParticipants will apply 0.02mL/cm2 of product topically via semi-occlusive patches onto dorsum (Scapular region).	Other	Test Product 4
Saline Solution Sodium ChlorideParticipants will apply 0.02mL/cm2 of product topically via semi-occlusive patches onto dorsum (Scapular region).	Other	Reference Product

Primary outcome

Frequency of Dermal Response Score at 15-30 Minutes Post Patch Removal
Time frame: At Day 2 (15-30 minutes post patch removal)
Product tolerability was assessed by Dermal Response Score. Test sites were evaluated 15-30 minutes following patch removal on Day 2 post 24 hrs of patch application. Response score from 0 to 7; 0= No evidence of irritation, 1= Minimal erythema, barely perceptible, 2= Definite erythema, readily visible; minimal edema or minimal papular response, 3= Erythema and papules, 4= Definite edema, 5= Erythema, edema and papules, 6= Vesicular eruption, 7= Strong reaction spreading beyond test site.
Frequency of Dermal Response Score at 24 Hours Post Patch Removal
Time frame: At Day 3 (24 hours post patch removal)
Product tolerability was assessed by Dermal Response Score. Test sites were evaluated 24 hours following patch removal on Day 3 post 48 hrs of patch application. Response score from 0 to 7; 0= No evidence of irritation, 1= Minimal erythema, barely perceptible, 2= Definite erythema, readily visible; minimal edema or minimal papular response, 3= Erythema and papules, 4= Definite edema, 5= Erythema, edema and papules, 6= Vesicular eruption, 7= Strong reaction spreading beyond test site.
Frequency of Dermal Response Score at 48 Hours Post Patch Removal
Time frame: At Day 4 (48 hours post patch removal)
Product tolerability was assessed by Dermal Response Score. Test sites were evaluated 48 hours following patch removal on Day 4 post 72 hours of patch application. Response score from 0 to 7; 0= No evidence of irritation, 1= Minimal erythema, barely perceptible, 2= Definite erythema, readily visible; minimal edema or minimal papular response, 3= Erythema and papules, 4= Definite edema, 5= Erythema, edema and papules, 6= Vesicular eruption, 7= Strong reaction spreading beyond test site.
Average Dermal Response Score at 30 Minutes Post Patch Removal
Time frame: At Day 2 (15-30 minutes post patch removal)
Product tolerability was assessed by Dermal Response Score. Test sites were evaluated 15-30 minutes following patch removal on Day 2 post 24 hours of patch application. Response score from 0 to 7; 0= No evidence of irritation, 1= Minimal erythema, barely perceptible, 2= Definite erythema, readily visible; minimal edema or minimal papular response, 3= Erythema and papules, 4= Definite edema, 5= Erythema, edema and papules, 6= Vesicular eruption, 7= Strong reaction spreading beyond test site.
Average Dermal Response Score at 24 Hours Post Patch Removal
Time frame: At Day 3 (24 hours post patch removal)
Product tolerability was assessed by Dermal Response Score. Test sites were evaluated 24 hours following patch removal on Day 3 post 48 hours of patch application. Response score from 0 to 7; 0= No evidence of irritation, 1= Minimal erythema, barely perceptible, 2= Definite erythema, readily visible; minimal edema or minimal papular response, 3= Erythema and papules, 4= Definite edema, 5= Erythema, edema and papules, 6= Vesicular eruption, 7= Strong reaction spreading beyond test site.
Average Dermal Response Score at 48 Hours Post Patch Removal
Time frame: At Day 4 (48 hours post patch removal)
Product tolerability was assessed by Dermal Response Score. Test sites were evaluated 48 hours following patch removal on Day 4 post 72 hours of patch application. Response score from 0 to 7; 0= No evidence of irritation, 1= Minimal erythema, barely perceptible, 2= Definite erythema, readily visible; minimal edema or minimal papular response, 3= Erythema and papules, 4= Definite edema, 5= Erythema, edema and papules, 6= Vesicular eruption, 7= Strong reaction spreading beyond test site.

1 secondary outcome

Number of Participants With Combined Skin Irritation (Dermal Response) Scores at 30 Minutes, 24 Hours and 48 Hours Post Patch Removal
Time frame: At Day 2 (15-30 minutes), Day 3 (24 hours) and Day 4 (48 hours) post patch removal

Results and safety

Results posted to the registry on 7 Sep 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Overall Participants	40	39

Primary outcome: Frequency of Dermal Response Score at 15-30 Minutes Post Patch Removal

Time frame: At Day 2 (15-30 minutes post patch removal). Count of participants. Unit: Participants

Measure	Test Product 1 n = 39	Test Product 2 n = 39	Test Product 3 n = 39	Test Product 4 n = 39	Reference Product n = 39
Missing	0	0	0	0	0
0	39	39	39	39	39
1	0	0	0	0	0
2	0	0	0	0	0
3	0	0	0	0	0
4	0	0	0	0	0
5	0	0	0	0	0
6	0	0	0	0	0

Population analysed: The ITT (N= 39) population included all participants who were randomized into the study and have skin irritation scores from at least one of the test sites available.

Primary outcome: Frequency of Dermal Response Score at 24 Hours Post Patch Removal

Time frame: At Day 3 (24 hours post patch removal). Count of participants. Unit: Participants

Measure	Test Product 1 n = 39	Test Product 2 n = 39	Test Product 3 n = 39	Test Product 4 n = 39	Reference Product n = 39
Missing	0	0	0	0	0
0	39	39	39	39	39
1	0	0	0	0	0
2	0	0	0	0	0
3	0	0	0	0	0
4	0	0	0	0	0
5	0	0	0	0	0
6	0	0	0	0	0

Population analysed: The ITT (N= 39) population included all participants who were randomized into the study and have skin irritation scores from at least one of the test sites available.

Primary outcome: Frequency of Dermal Response Score at 48 Hours Post Patch Removal

Time frame: At Day 4 (48 hours post patch removal). Count of participants. Unit: Participants

Measure	Test Product 1 n = 39	Test Product 2 n = 39	Test Product 3 n = 39	Test Product 4 n = 39	Reference Product n = 39
Missing	0	0	0	0	0
0	39	39	39	39	39
1	0	0	0	0	0
2	0	0	0	0	0
3	0	0	0	0	0
4	0	0	0	0	0
5	0	0	0	0	0
6	0	0	0	0	0

Population analysed: The ITT (N= 39) population included all participants who were randomized into the study and have skin irritation scores from at least one of the test sites available.

Primary outcome: Average Dermal Response Score at 30 Minutes Post Patch Removal

Time frame: At Day 2 (15-30 minutes post patch removal). Mean (Standard Deviation). Unit: Score on Scale

Measure	Test Product 1 n = 39	Test Product 2 n = 39	Test Product 3 n = 39	Test Product 4 n = 39	Reference Product n = 39
Value	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)

Population analysed: The ITT (N= 39) population included all participants who were randomized into the study and have skin irritation scores from at least one of the test sites available.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Approximately 4 days. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Test Product 1	0 of 40 (0%)	0 of 40 (0%)	0 of 40
Test Product 2	0 of 40 (0%)	0 of 40 (0%)	0 of 40
Test Product 3	0 of 40 (0%)	0 of 40 (0%)	0 of 40
Test Product 4	0 of 40 (0%)	0 of 40 (0%)	0 of 40
Reference Product	0 of 40 (0%)	0 of 40 (0%)	0 of 40
Overall Participants	0 of 40 (0%)	0 of 40 (0%)	0 of 40

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.
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 Experimental Daily Defense Serum A, Experimental Daily Defense Serum C and Experimental Daily Defense Serum G 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 4 inclusion and 25 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 16 Jan 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. Some participants in this study may receive a placebo. 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 7 Sep 2018). 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 Dermal Response Score at 15-30 Minutes Post Patch Removal (time frame: At Day 2 (15-30 minutes post patch removal)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03233009.

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 16 Jan 2019.