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HealthyNCT06243627

A Study to Assess Safety and Improvement in Skin Barrier After Using 2 Facial Sunscreens in Adults With Sensitive Skin

A study testing Sunscreen C Color 2.0 SPF 70, Sunscreen C Color 3.0 SPF 70 and Sunscreen M Very Light SPF 50 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

The purpose of this trial is to evaluate 1) the dermatological tolerability of 2 facial sunscreens after 21 (+2) days of use under normal conditions on the half face by adult subjects with sensitive skin, 2) Compare the efficacy of investigational products (IPs) after 21 (+2) days of use in adult subjects with… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Sunscreen C Color 2.0 SPF 70, Sunscreen C Color 3.0 SPF 70 and Sunscreen M Very Light SPF 50
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteBrazil
Study dates
27 Sep 2023to 11 Dec 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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Participants vaccinated against coronavirus disease 2019 (COVID-19)
  • Participants of any gender
  • Participants of any ethnicities according to Brazilian Institute of Geography and Statistics (IBGE) criteria
  • Phototype II to IV according to Fitzpatrick's classification
  • Participants - in good health based on medical history reported by the subject
  • Participants presenting intact skin on the face, with the exception of clinical signs characteristic of sensitive skin
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  • Participants who declare themselves as having sensitive skin (according to the Institute's sensitive skin questionnaire, completed in the recruitment phase and reconfirmed by the physician on the day of inclusion)
  • Able to read, write, speak and understand Portuguese (able to read and understand the documents delivered and what is explained to them)
  • Participants who agree to maintain their cosmetic habits during the study period
  • Participants who agree to maintain their cosmetic habits during the study period
  • Participant who signed the Informed Consent Document (ICD)
  • Agreement 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 assessments
  • Participant that intend to complete the study and is willing and able to follow all study instructions

Who cannot join

  • Participants that have had allergies or adverse reactions to common topical skincare products, including sunscreens, medications, or other products that the investigator considers relevant
  • Participants that present a skin condition that may influence the study results (specifically psoriasis, eczema, atopic dermatitis, cutaneous xerosis, intense erythema, or active skin cancer). Mild erythema and xerosis associated with a sensitive skin condition are acceptable for eligibility
  • Participants that present primary/secondary lesions (for example: scars, ulcers, vesicles, vitiligo) or tattoos on the test areas
  • Participants that have undertaken cosmetic or dermatological treatment, invasive or non-invasive, in the test areas within 3 weeks before the beginning of the study and during the study
  • Participants that have self-reported Type 1 or Type 2 diabetes or are taking insulin or another anti-diabetic medication
  • Participants that are taking a medication that would mask an adverse event (AE) or influence the study results, including: Immunosuppressive or steroidal drugs within 2 months before Visit 1; Non-steroidal anti-inflammatory drugs within 5 days before Visit 1; Antihistamines within 2 weeks before Visit 1. If an individual is taking one of these medication types, the individual is not considered eligible at screening. However, if a subject begins using one of these medications during the study, the study physician should be consulted to consider the impact of the specific medication on subject safety and/or the study results, as described in section "Concurrent/Concomitant Medication"
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  • Participants that are self-reported to be pregnant or planning to become pregnant during the study
  • Participants that have a history of a health condition/situation which may put the individual at significant risk, influence the study results, or interfere significantly with the individual's participation in the study
  • Participants that are simultaneously participating in any other study
  • Participants that are employees/contractors or immediate family members of the principal investigator (PI), study site, or sponsor
  • History of non-adherence or unwillingness to adhere to the study protocol
  • Any condition not previously mentioned that, in the opinion of the PI, may compromise the study evaluation

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Allergisa Pesquisa Dermato-Cosmetica Ltda

    Campinas, São Paulo, 13084-791

Other trials in Brazil

About this study

Official title: A Single-Center, Comparative, Randomized, Safety-in-Use Clinical Study to Assess Skin Acceptability and Efficacy in Improving Skin Barrier Function of Two Facial Sunscreens in Adult Participants With Sensitive Skin

The purpose of this trial is to evaluate 1) the dermatological tolerability of 2 facial sunscreens after 21 (+2) days of use under normal conditions on the half face by adult subjects with sensitive skin, 2) Compare the efficacy of investigational products (IPs) after 21 (+2) days of use in adult subjects with sensitive skin, under dermatological supervision through the following evaluations: the transepidermal water loss in the nasolabial region; the sensory perception of the subjects using the sensory perception questionnaire, after 21 (+2) days of use under normal conditions; the sensitivity of the subjects' skin after the first application of each product using a questionnaire on the perception of signs of discomfort.

Conditions
Healthy
Being tested
Sunscreen C Color 2.0 SPF 70, Sunscreen C Color 3.0 SPF 70, Sunscreen M Very Light SPF 50, Sunscreen M Golden Color SPF 50

What participants receive

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

  • Sunscreen C Color 2.0 SPF 70Other

    Also called E003431A-01

    Sunscreen C color 2.0 SPF 70 will be applied topically on half of the face.

  • Sunscreen C Color 3.0 SPF 70Other

    Also called E003431A-02

    Sunscreen C color 3.0 SPF 70 will be applied topically on half of the face.

  • Sunscreen M Very Light SPF 50Other

    Also called E003431A-03

    Sunscreen M very light SPF 50 will be applied topically on half of the face.

  • Sunscreen M Golden Color SPF 50Other

    Also called E003431A-04

    Sunscreen M golden color SPF 50 will be applied topically on half of the face.

Study groups in NCT06243627
Study groupRoleWhat they receive
Arm 1: Sunscreen C Color 2.0 Sun Protection Factor (SPF) 70 and Sunscreen M Very Light SPF 50ExperimentalThe participants will apply topically two colored sunscreens: C color 2.0 and M very light, one on each half of the face at least twice a day for 21 days.
Receives: Other: Sunscreen C Color 2.0 SPF 70; Other: Sunscreen M Very Light SPF 50
Arm 2: Sunscreen C Color 2.0 SPF 70 and Sunscreen M Golden Color SPF 50ExperimentalThe participants will apply topically two colored sunscreens: C color 2.0 and M golden color, one on each half of the face at least twice a day for 21 days.
Receives: Other: Sunscreen C Color 2.0 SPF 70; Other: Sunscreen M Golden Color SPF 50
Arm 3: Sunscreen C Color 3.0 SPF 70 and Sunscreen M Very Light SPF 50ExperimentalThe participants will apply topically two colored sunscreens: C color 3.0 and M very light, one on each half of the face at least twice a day for 21 days.
Receives: Other: Sunscreen C Color 3.0 SPF 70; Other: Sunscreen M Very Light SPF 50
Arm 4: Sunscreen C Color 3.0 SPF 70 and Sunscreen M Golden Color SPF 50ExperimentalThe participants will apply topically two colored sunscreens: C color 3.0 and M golden color, one on each half of the face at least twice a day for 21 days.
Receives: Other: Sunscreen C Color 3.0 SPF 70; Other: Sunscreen M Golden Color SPF 50

What is being measured

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

  1. Change From Baseline in Dermatological Tolerability

    Change from baseline in dermatological tolerability will be reported. Dermatological tolerability includes a clinical assessment of the participant's initial skin condition, carried out by the study dermatologist according to the Skin Reaction Intensity Assessment Scale. Skin reaction intensity assessment of erythema, edema, blistering and peeling on the face will be done. Each skin reaction was scored on 4-point scale 0 = absent, 1 = mild, 2 =moderate, and 3 = intense. A decrease in score at post-baseline timepoints compared to baseline indicates an improvement.

    Measured: Baseline (Day 1), Day 21

  2. Change From Baseline in Skin Barrier Integrity

    Change from baseline in skin barrier integrity will be reported. The facial skin barrier will be assessed by a trained technician using instrumental measurements with the Tewameter TM 300. The Tewameter measures transepidermal water loss (TEWL) that is the flow of water out of the skin. TEWL measurement will be taken in the nasolabial region of each half of the face.

    Measured: Baseline (Day 1), Day 21

  3. Number of Participants With Sensory Perception as Assessed by Sensory Perception Questionnaire

    Number of participants with sensory perception as assessed by sensory perception questionnaire will be reported. The sensory perception of each sunscreen will be concluded from the data obtained from the sensory perception questionnaire which includes overall satisfaction, skin and eye irritation, comfort and other characteristics (stickiness, lightness etcetera). Sensory perception questionnaire includes 1 question on overall satisfaction with sunscreen by scoring on a scale ranged from 1 to 7, 1= disliked very much and 7= liked very much; 3 questions with participant's response on "does not irritate the skin, eye and felt comfortable using the sunscreen" on a response scale ranging from 1 to 5, 1= strongly disagree and 5= strongly agree; and 1 question that correlate the characteristic (stickiness, lightness etcetera.) with each product tested.

    Measured: At Day 21

  4. Number of Participants With Skin Sensitivity as Assessed by Discomfort Questionnaire

    Number of participants with skin sensitivity as assessed by perception questionnaire on discomfort signs will be reported. Assessment of skin sensitivity after application of each sunscreen will be concluded from the data obtained by filling in the questionnaire on the perception of signs of discomfort. Perception questionnaire on discomfort signs includes sensation of discomfort, burning sensation, itching, redness sensation on skin and eye irritation. For each sign the participant will select a response on a scale ranging from 0 to 9, where 0 = no discomfort sign and 9= intense discomfort sign. Higher score indicates intense discomfort sign. If a participant has a moderate or/to intense reaction (from 4 to 9) an adverse event will be open.

    Measured: At Day 1

  5. Number of Participants With Adverse Events

    Number 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 Day 21

Timeline

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

  1. First posted6 Feb 2024
  2. Study start27 Sep 2023
  3. Primary completion30 Nov 2023
  4. Study completion11 Dec 2023

Resources

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
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06243627
Sponsor's protocol ID
CCSSKA005438
Status last verified
Jan 2024
First submitted
29 Jan 2024
Last updated
6 Feb 2024
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.

Questions about this trial

What is this clinical trial studying?

A study testing Sunscreen C Color 2.0 SPF 70, Sunscreen C Color 3.0 SPF 70 and Sunscreen M Very Light SPF 50 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 13 inclusion and 12 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 6 Feb 2024. 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?

Change From Baseline in Dermatological Tolerability (time frame: Baseline (Day 1), Day 21). The study lists 5 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 NCT06243627.

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 6 Feb 2024.

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