HealthyNCT05972434

A Study of Two Facial Sunscreens to Assess Its Effect in Improving Hydration, Skin Barrier Function, and Skin Tone Uniformity Under Controlled and Normal Conditions of Use on the Face by Adult Participants

A study testing Sunscreen A and Sunscreen B in people with Healthy, run by Johnson & Johnson Consumer Inc. (J&JCI) at 1 site in Brazil.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Sunscreen A and Sunscreen B
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 82 participants
Where: 1 siteBrazil
Study dates: 3 Apr 2023to 21 Jul 2023
Phase: Interventional
Are there results?: None posted in the registry

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 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Participants of any ethnicity according to IBGE criteria
Generally in good health based on medical history reported by the participant
Able to read, write, speak, and understand Portuguese
Capacity to consent to participation in the study
Fitzpatrick Skin Type I to IV
Intact skin in the test region

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Specific for Group 1: Participants with dry skin on the forearms (Corneometer score of maximum 40 arbitrary units (a.u.) at initial measurement before application of the products
Participants with a maximum facial corneometry value of 60 a.u. at the initial measurement before the application of the products
Participants presenting recent and repetitive complaints of discomfort caused by dry skin on the face, such as: pining, itching, irritation, et cetra
Specific for Group 2: Participants who present lack of homogeneity in the tone of the facial skin due to hyperchromia caused by sun spots, solar lentigo, post-inflammatory hyperpigmentation, ephelid and mild melasma (proven by Dermatologist)
Specific for Group 2: Participants who present lack of radiance in the skin (proven by Dermatologist)
Individual who has signed the informed consent document (ICD) and image disclosure consent term (IDCT)
Concordance to adhere to the procedures and requirements of the study and to attend the Site on the day(s) and time(s) determined for the evaluations
For male participants: agree to shave 24 hours before visit 1, 2 and 3

Who cannot join

Has known allergies or adverse reactions to common topical skin care products including sunscreen
Presents with a skin condition that may confound the study results (specifically psoriasis, eczema, active atopic dermatitis, active skin cancer)
Presents with primary/secondary lesions on test sites (example. scars, ulcers, vesicles, tattoos)
Report having Type 1 or Type 2 diabetes or taking insulin or another anti-diabetic medication: presents immunological insufficiency; Is taking a medication that would mask an Adverse Event (AE) or confound the study results, including; Immunosuppressive or steroidal drugs within 60 days before Visit 1; Non-steroidal anti-inflammatory drugs within 5 days before Visit 1; Antihistamines within 14 days before Visit 1
Participants who are currently using or have recently used any facial products containing active skin barrier replacement and intense moisturizing ingredients such as: urea, ceramides, hyaluronic acid, glycerin, butters and oils, within 2 months prior to the start of the study
Participants who have used cosmetic products for facial and body moisturizing (on the forearms) within 07 days prior to the start of the study

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Specific for Group 2: Participants who are using or have recently used any facial products containing active ingredients against spots: alpha or beta hydroxy acids (including salicylic acid), polyhydroxy acids, topical products containing retinol or retinol derivatives, hydroquinones, arbutin, niacinamide, N-acetylglucosamine, Thiamidol, kojic acid, azelaic acid, licorice extract, whitening peptides, vitamin C, or any other product capable of interfering with the uniformity of skin tone/spots, within 2 months prior to the start of the study
Participants who have undergone invasive cosmetic or dermatological treatment in the test areas within 2 months prior to the start of the study or during the study
Participants who are using any medication to treat diseases of the face or body
Other diseases or medications that may directly interfere with the study or endanger the health of the research participant
Is self-reported to be pregnant or planning to become pregnant during the study
Has a history of or a concurrent health/other condition/situation which, in the opinion of the Study Physician, may put the individual at significant risk, confound the study results, or interfere significantly with the individual's participation in the study
Is simultaneously participating in any other study
Is an employee/contractor or immediate family member of the principal investigator (PI), Study Site, or Sponsor
Presents excessive hair in the evaluation regions that may interfere with the instrumental measurements. In the case of men, they will be instructed to shave 24 hours before the visit

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Allergisa Pesquisa Dermato-Cosmética Ltda
Campinas, São Paulo, 13084-791

Other trials in Brazil

About this study

Official title: A Single-Center, Open-Label Safety-in-Use Clinical Trial to Assess the Topical Tolerability and Efficacy in Improving Hydration, Skin Barrier Function, and Skin Tone Uniformity of Two Facial Sunscreens (IPs) Under Controlled and Normal Conditions of Use on the Face by Adult Participants

The purpose of this study is to evaluate the safety and efficacy of 02 facial sunscreens (investigational products [IPs]) under controlled and normal conditions of use on the face for 28 and 56 days, respectively. This study will consist of 2 groups a) Group 1: will assess the safety and efficacy of a facial sunscreen in improving skin hydration and barrier function, through 12h of single application on the face in comparison with the control area (other side of face) and on the forearm, comparing 02 IPs versus control area (no product application) and 03 benchmarks; and through use of the IP under normal conditions for 28 +/- 2 days on the face, with assessments by instrumental measurements of corneometry, transepidermal water loss, image capture (Colorface) and assessments of the efficacy perceived by the participant; b) Group 2: will evaluate the safety and efficacy of a facial sunscreen in improving skin hydration and barrier function, through 12h of single application on the face; and through use of IP under normal conditions for 28 +/- 2 days on the face, with assessments by instrumental measurements of corneometry, transepidermal water loss, imaging (Colorface) and assessments of the efficacy perceived by the participant; in addition to evaluating the improvement in uniformity of facial skin tone through the use of IP under normal conditions for 56 +/- 2 days, with assessments by image analysis (Colorface), dermatological clinical analyses (radiance and homogeneity of skin tone),assessments of perceived efficacy, and emotional testimony by the participant.

Conditions: Healthy
Being tested: Sunscreen A, Sunscreen B

What participants receive

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

Sunscreen AOther
Participants will apply sunscreen A topically.
Sunscreen BOther
Participants will apply sunscreen B topically.

Study groups in NCT05972434
Study group	Role	What they receive
Group 1: Sunscreen A	Experimental	Eligible study participants will receive a standard liquid soap to be used on the face and forearms for 3 full days for an initial washout period in place of their usual soap. On their next visit to site an amount of IP will be topically applied to malar on one side of the participant's face by a qualified technician and other side of face will remain without product application (used for control). Six areas will also be marked on inner side of participant's forearms, approximately 5 centimeter (cm) from cubital region. These areas will be randomized, with 1 area for control (without product application) and other 5 areas for product application, being each of them for 02 IPs (Facial Sunscreen A and Face Sunscreen B) and 3 benchmarks. The products will be applied topically only once in marked areas. Next, participants will use Facial Sunscreen A in normal conditions at home for 28 +/- 2 days and then make the last study visit to complete the final analysis. Receives: Other: Sunscreen A
Group 2: Sunscreen B	Experimental	Eligible study participants will receive a standard liquid soap to be used on the face for 3 full days for an initial washout period in place of their usual soap. On their next visit to the Site an amount of the IP will be topically applied to the malar on one side of the participants' face by a qualified technician and the other side of the face will remain without product application (used for control). On their next visit to the Site an amount of the IP will be topically applied to the malar on one side of the participants' face by a qualified technician and the other side of the face will remain without product application (used for control). From Visit 2 to visit 4 participants will use the IP (Face Sunscreen B) at home until 56 +/-2 days of use. Receives: Other: Sunscreen B

What is being measured

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

Groups 1 and 2: Skin Hydration as Assessed Through Instrumental Corneometry Measurements During 12 Hours of Visit 2
Instrumental corneometry will be used to assess improvement in skin hydration during 12 hours of single application on one side of the face (hemi-face), in comparison with the control area (other side of face, without product application). The investigational product (IP) will be applied only once on half face, on the malar region, by a trained technician. The treated area and the control area will be tested in triplicate at each experimental time (T0h, T2h, T4h, T6h, T8h and T12h), with the corneometer instrument.
Measured: 0 hour, 2 hours, 4 hours, 6 hours, 8 hours and 12 hours (Visit 2)
Groups 1 and 2: Skin Hydration as Assessed Through Instrumental Skin Corneometry Measurements at Day 28 +/- 2
Instrumental corneometry measurements will be used to assess improvement in skin hydration at Day 28 +/- 2 of application on the face (normal conditions of use). The IP will be applied on the entire face throughout the 28 days period. There should not be any type of product applied to the evaluation area at the time of the measurements.
Measured: Up to Day 28 +/- 2
Groups 1 and 2: Skin Barrier Integrity as Assessed Through Tewameter Measurements
Skin barrier measurements (an initial measurement at Visit 2 and a final measurement at Visit 3) will be performed with the Tewameter. A single transepidermal water loss (TEWL) measurement will be taken in the nasegenian region, on the face of the participants. There should not be any type of product applied to the evaluation area at the time of the measurements.
Measured: Day 28 +/- 2
Groups 1 and 2: Participant's Self-perceived Efficacy Questionnaire to Assess Clinical Effectiveness
Participant's self-perceived questionnaire to assess the clinical effectiveness of the sunscreen will be reported. It is a 9-item questionnaire and each item is rated as totally disagree, disagree, neither agree nor disagree, agree and totally agree. Participants will additionally answer 1 question and rate it as liked very much, liked slightly, neither liked nor disliked, disliked slightly and disliked very much.
Measured: Day 28 +/- 2
Group 1:Percentage of Participants with Adverse Events
Percentage of participants with adverse events will be reported. An adverse event is any untoward medical occurrence in a clinical study participant temporally associated with the clinical investigation, whether or not the event has a causal relationship to the participants' participation in the trial. It is therefore any unfavorable and unintended sign (including an abnormal finding), symptom, or disease that occurs during the trial. This can include any occurrence that is new in onset, an aggravation of severity/ frequency of a baseline condition, or abnormal results of diagnostic procedures, including laboratory test abnormalities.
Measured: Up to 28 +/- 2 days
Group 2: Facial Skin Tone as Assessed Through Radiance/Brightness/Luminousness Scale
To evaluate the parameters of radiance of the participant's skin tone, radiance/brightness/luminousness ordinal scale developed by the study site will be used. Radiance/Brightness/Luminousness scale is a 10-point system (0 to 9) that grades the intensity of these attributes, where 0 to 3: characteristic of "radiant, bright and luminous appearance" skin, 4 to 6: moderately radiant, and 7 to 9: characteristic of "dull/matte and/or pale" skin.
Measured: Up to Day 56 +/- 2
Group 2: Facial Skin Tone as Assessed Through Skin Tone Uniformity/Homogeneity Scale
To evaluate the parameters of uniformity of the participant's skin tone, skin tone uniformity/homogeneity ordinal scale developed by the study site will be used. Skin tone uniformity/homogeneity ordinal scale is a 10-point system (0 to 9) that rates the intensity of these attributes, where 0 to 3 is characteristic of " even/healthy color" skin, 4 to 6 is moderately even, and 7 to 9 is characteristic of " irregular, discolored, spotted" skin.
Measured: Up to Day 56 +/- 2
Group 2: Facial Skin Tone as Assessed Through Image Analysis via Colorface
Image analysis via Colorface will be used to assess improvement in facial skin tone. The images of the participants faces will be captured with Colorface equipment (Newtone Technology) that will be operated by a trained technician.
Measured: Day 56 +/- 2
Group 2: Testimonial Regarding the Experience with Sunscreen
A testimonial regarding the experience with sunscreen will be provided by the participants through an open question at the end of the study. The purpose is to know their opinion and experience using this product during the study.
Measured: Day 56
Group 2:Percentage of Participants with Adverse Events
Percentage of participants with adverse events will be reported. An adverse event is any untoward medical occurrence in a clinical study participant temporally associated with the clinical investigation, whether or not the event has a causal relationship to the participants' participation in the trial. It is therefore any unfavorable and unintended sign (including an abnormal finding), symptom, or disease that occurs during the trial. This can include any occurrence that is new in onset, an aggravation of severity/ frequency of a baseline condition, or abnormal results of diagnostic procedures, including laboratory test abnormalities.
Measured: Up to 56 +/- 2 days
Group 2: Participant's Self-perceived Efficacy Questionnaire to Assess Clinical Effectiveness
Participant's self-perceived questionnaire to assess the clinical effectiveness of the sunscreen on Day 56 will be reported. Participants will answer 12 questions and rate as: totally disagree, disagree, neither agree nor disagree, agree and totally agree. Participants will additionally answer 2 questions and rate them as liked very much, liked slightly, neither liked nor disliked.
Measured: Day 56 +/-2

Secondary outcomes (2)

Group 1 and 2: Skin Hydration as Assessed by Hydration Map
Facial images will be captured with ColorFace (Newtone Technology) equipment at the baseline and Day 28 to build a facial hydration map for the in-use study.
Measured: Up to Day 28+/- 2 days
Group 1: Skin Hydration as Assessed Through Instrumental Forearms Corneometry Measurements During 12 Hours of Visit 2
Six areas will be marked on the inner side of the participants' forearms, approximately 5 cm from the cubital region. These areas will be randomized, with 1 area for control (without product application) and the other 5 areas for product application, being each of them for 02 IPs (Facial Sunscreen A and Face Sunscreen B) and 3 benchmarks. The products will be applied topically only once in the marked areas. The 6 areas will be tested in triplicate at each experimental time (T0h, T2h, T4h, T6h, T8h and T12h) with the corneometer equipment.
Measured: 0 hour, 2 hours, 4 hours, 6 hours, 8 hours and 12 hours (Visit 2)

Timeline

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

3 Apr 202321 Jul 2023

First posted2 Aug 2023
Study start3 Apr 2023
Primary completion23 Jun 2023
Study completion21 Jul 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies of the same condition, open and under way.
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: None (open label)
Enrolment: 82 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05972434
Sponsor's protocol ID: CCSSKA005284
Other IDs: CCSSKA005284
Status last verified: Jul 2023
First submitted: 30 Jun 2023
Last updated: 2 Aug 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Johnson \& Johnson Consumer Inc. has an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.

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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-Center, Open-Label Safety-in-Use Clinical Trial to Assess the Topical Tolerability and Efficacy in Improving Hydration, Skin Barrier Function, and Skin Tone Uniformity of Two Facial Sunscreens (IPs) Under Controlled and Normal Conditions of Use on the Face by Adult Participants
ClinicalTrials.gov ID: NCT05972434
Acronym / sponsor ID: CCSSKA005284
Conditions: Healthy
Study type: Interventional
Recruitment status: Completed
Enrolment: 82 participants (actual)
Lead sponsor: Johnson & Johnson Consumer Inc. (J&JCI)Industry (pharma, biotech, devices)
Study start: 3 Apr 2023 (actual)
Primary completion: 23 Jun 2023 (actual)
Study completion: 21 Jul 2023 (actual)
First posted: 2 Aug 2023 (actual)
Results: Not posted in the source record

Clinical summary

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

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Group 1: Sunscreen A	Experimental	Other: Sunscreen AEligible study participants will receive a standard liquid soap to be used on the face and forearms for 3 full days for an initial washout period in place of their usual soap. On their next visit to site an amount of IP will be topically applied to malar on one side of the participant's face by a qualified technician and other side of face will remain without product application (used for control). Six areas will also be marked on inner side of participant's forearms, approximately 5 centimeter (cm) from cubital region. These areas will be randomized, with 1 area for control (without product application) and other 5 areas for product application, being each of them for 02 IPs (Facial Sunscreen A and Face Sunscreen B) and 3 benchmarks. The products will be applied topically only once in marked areas. Next, participants will use Facial Sunscreen A in normal conditions at home for 28 +/- 2 days and then make the last study visit to complete the final analysis.
Group 2: Sunscreen B	Experimental	Other: Sunscreen BEligible study participants will receive a standard liquid soap to be used on the face for 3 full days for an initial washout period in place of their usual soap. On their next visit to the Site an amount of the IP will be topically applied to the malar on one side of the participants' face by a qualified technician and the other side of the face will remain without product application (used for control). On their next visit to the Site an amount of the IP will be topically applied to the malar on one side of the participants' face by a qualified technician and the other side of the face will remain without product application (used for control). From Visit 2 to visit 4 participants will use the IP (Face Sunscreen B) at home until 56 +/-2 days of use.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (14 listed)

Participants of any ethnicity according to IBGE criteria
Generally in good health based on medical history reported by the participant
Able to read, write, speak, and understand Portuguese
Capacity to consent to participation in the study
Fitzpatrick Skin Type I to IV

Key exclusion criteria (15 listed)

Has known allergies or adverse reactions to common topical skin care products including sunscreen
Presents with a skin condition that may confound the study results (specifically psoriasis, eczema, active atopic dermatitis, active skin cancer)
Presents with primary/secondary lesions on test sites (example. scars, ulcers, vesicles, tattoos)
Report having Type 1 or Type 2 diabetes or taking insulin or another anti-diabetic medication: presents immunological insufficiency; Is taking a medication that would mask an Adverse Event (AE) or confound the study results, including; Immunosuppressive or steroidal drugs within 60 days before Visit 1; Non-steroidal anti-inflammatory drugs within 5 days before Visit 1; Antihistamines within 14 days before Visit 1
Participants who are currently using or have recently used any facial products containing active skin barrier replacement and intense moisturizing ingredients such as: urea, ceramides, hyaluronic acid, glycerin, butters and oils, within 2 months prior to the start 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
Sunscreen AParticipants will apply sunscreen A topically.	Other	Group 1: Sunscreen A
Sunscreen BParticipants will apply sunscreen B topically.	Other	Group 2: Sunscreen B

Primary outcome

Groups 1 and 2: Skin Hydration as Assessed Through Instrumental Corneometry Measurements During 12 Hours of Visit 2
Time frame: 0 hour, 2 hours, 4 hours, 6 hours, 8 hours and 12 hours (Visit 2)
Instrumental corneometry will be used to assess improvement in skin hydration during 12 hours of single application on one side of the face (hemi-face), in comparison with the control area (other side of face, without product application). The investigational product (IP) will be applied only once on half face, on the malar region, by a trained technician. The treated area and the control area will be tested in triplicate at each experimental time (T0h, T2h, T4h, T6h, T8h and T12h), with the corneometer instrument.
Groups 1 and 2: Skin Hydration as Assessed Through Instrumental Skin Corneometry Measurements at Day 28 +/- 2
Time frame: Up to Day 28 +/- 2
Instrumental corneometry measurements will be used to assess improvement in skin hydration at Day 28 +/- 2 of application on the face (normal conditions of use). The IP will be applied on the entire face throughout the 28 days period. There should not be any type of product applied to the evaluation area at the time of the measurements.
Groups 1 and 2: Skin Barrier Integrity as Assessed Through Tewameter Measurements
Time frame: Day 28 +/- 2
Skin barrier measurements (an initial measurement at Visit 2 and a final measurement at Visit 3) will be performed with the Tewameter. A single transepidermal water loss (TEWL) measurement will be taken in the nasegenian region, on the face of the participants. There should not be any type of product applied to the evaluation area at the time of the measurements.
Groups 1 and 2: Participant's Self-perceived Efficacy Questionnaire to Assess Clinical Effectiveness
Time frame: Day 28 +/- 2
Participant's self-perceived questionnaire to assess the clinical effectiveness of the sunscreen will be reported. It is a 9-item questionnaire and each item is rated as totally disagree, disagree, neither agree nor disagree, agree and totally agree. Participants will additionally answer 1 question and rate it as liked very much, liked slightly, neither liked nor disliked, disliked slightly and disliked very much.
Group 1:Percentage of Participants with Adverse Events
Time frame: Up to 28 +/- 2 days
Percentage of participants with adverse events will be reported. An adverse event is any untoward medical occurrence in a clinical study participant temporally associated with the clinical investigation, whether or not the event has a causal relationship to the participants' participation in the trial. It is therefore any unfavorable and unintended sign (including an abnormal finding), symptom, or disease that occurs during the trial. This can include any occurrence that is new in onset, an aggravation of severity/ frequency of a baseline condition, or abnormal results of diagnostic procedures, including laboratory test abnormalities.
Group 2: Facial Skin Tone as Assessed Through Radiance/Brightness/Luminousness Scale
Time frame: Up to Day 56 +/- 2
To evaluate the parameters of radiance of the participant's skin tone, radiance/brightness/luminousness ordinal scale developed by the study site will be used. Radiance/Brightness/Luminousness scale is a 10-point system (0 to 9) that grades the intensity of these attributes, where 0 to 3: characteristic of "radiant, bright and luminous appearance" skin, 4 to 6: moderately radiant, and 7 to 9: characteristic of "dull/matte and/or pale" skin.
Group 2: Facial Skin Tone as Assessed Through Skin Tone Uniformity/Homogeneity Scale
Time frame: Up to Day 56 +/- 2
To evaluate the parameters of uniformity of the participant's skin tone, skin tone uniformity/homogeneity ordinal scale developed by the study site will be used. Skin tone uniformity/homogeneity ordinal scale is a 10-point system (0 to 9) that rates the intensity of these attributes, where 0 to 3 is characteristic of " even/healthy color" skin, 4 to 6 is moderately even, and 7 to 9 is characteristic of " irregular, discolored, spotted" skin.
Group 2: Facial Skin Tone as Assessed Through Image Analysis via Colorface
Time frame: Day 56 +/- 2
Image analysis via Colorface will be used to assess improvement in facial skin tone. The images of the participants faces will be captured with Colorface equipment (Newtone Technology) that will be operated by a trained technician.
Group 2: Testimonial Regarding the Experience with Sunscreen
Time frame: Day 56
A testimonial regarding the experience with sunscreen will be provided by the participants through an open question at the end of the study. The purpose is to know their opinion and experience using this product during the study.
Group 2:Percentage of Participants with Adverse Events
Time frame: Up to 56 +/- 2 days
Percentage of participants with adverse events will be reported. An adverse event is any untoward medical occurrence in a clinical study participant temporally associated with the clinical investigation, whether or not the event has a causal relationship to the participants' participation in the trial. It is therefore any unfavorable and unintended sign (including an abnormal finding), symptom, or disease that occurs during the trial. This can include any occurrence that is new in onset, an aggravation of severity/ frequency of a baseline condition, or abnormal results of diagnostic procedures, including laboratory test abnormalities.
Group 2: Participant's Self-perceived Efficacy Questionnaire to Assess Clinical Effectiveness
Time frame: Day 56 +/-2
Participant's self-perceived questionnaire to assess the clinical effectiveness of the sunscreen on Day 56 will be reported. Participants will answer 12 questions and rate as: totally disagree, disagree, neither agree nor disagree, agree and totally agree. Participants will additionally answer 2 questions and rate them as liked very much, liked slightly, neither liked nor disliked.

2 secondary outcomes

Group 1 and 2: Skin Hydration as Assessed by Hydration Map
Time frame: Up to Day 28+/- 2 days
Group 1: Skin Hydration as Assessed Through Instrumental Forearms Corneometry Measurements During 12 Hours of Visit 2
Time frame: 0 hour, 2 hours, 4 hours, 6 hours, 8 hours and 12 hours (Visit 2)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2023.
Individual participant dataSharing planned: Yes. Johnson \& Johnson Consumer Inc. has an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.

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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.

Gabrielli Brianezi principal investigator

Allergisa Pesquisa Dermato-Cosmética Ltda

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Sunscreen A and Sunscreen B in people with Healthy, run by Johnson & Johnson Consumer Inc. (J&JCI) at 1 site 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 14 inclusion and 15 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 Aug 2023. 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 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Groups 1 and 2: Skin Hydration as Assessed Through Instrumental Corneometry Measurements During 12 Hours of Visit 2 (time frame: 0 hour, 2 hours, 4 hours, 6 hours, 8 hours and 12 hours (Visit 2)). The study lists 11 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 NCT05972434.

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 Aug 2023; AzTrials last refreshed its copy on 7 Nov 2026.