Acne VulgarisNCT06544889
A Study to Assess the Safety and Efficacy of a Sunscreen on Acne-Prone Skin With Inflammatory and Non-Inflammatory Acne Vulgaris
A study testing Sunscreen SPF 70 in people with Acne Vulgaris, run by JNTL Consumer Health (Brasil) LTDA at 1 site in Brazil.
Trial summary
The purpose of this trial is to evaluate 1) To assess the dermatological tolerability and the absence of acnegenic and comedogenic potential of 1 facial sunscreen, after 28 ± 2 days of use under normal conditions by adult subjects with acne prone skin, 2) To assess the clinical efficacy of the topical product in… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Sunscreen SPF 70
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteBrazil
- Study dates
- 9 May 2024to 18 Jun 2024
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and/or Women;
- 18 to 55 years old;
- Subjects vaccinated against COVID-19;
- Subjects of all ethnicities according to IBGE criteria - IBGE-The Brazilian Institute of Geography and Statistics;
- Phototypes I to IV according to the Fitzpatrick classification;
- Oily or combination skin with a tendency to acne - confirmed by a dermatologist;
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- Healthy skin in the test area (except for comedones and occasional inflammatory lesions - papules and pustules);
- Generally, in good health based on medical history reported by the subject;
- Subjects with mild elementary acne lesions (Grade 2 on the IGA scale), including non-inflammatory and/or inflammatory lesions (papules/pustules only, no nodular lesions) - proven by a dermatologist;
- Subjects presenting the following criteria on the face, confirmed by Expert Grader:
- At least 1 PIE
- At least PIH
- For male subjects: who agree to shave 24 hours before Visits 1, 2, and 3;
- Subjects able to read, write, speak, and understand Portuguese;
- Subjects who signed the terms ICD - Informed Consent Document and ICID - Informed Consent Image Disclosure;
- Intends to complete the study and is willing and able to follow all study instructions and attend the Site on the day(s) and at the time(s) set for the evaluations;
Who cannot join
- Has known allergies or adverse reactions to common topical skin care products including sunscreens; medications, or other products that the investigator deems relevant;
- Presents a skin condition that may confound the study results (specifically psoriasis, eczema, atopic dermatitis, cutaneous xerosis, erythema, or active skin cancer);
- Has self-reported Type 1 or Type 2 diabetes or is taking insulin or another anti-diabetic medication;
- Is taking a medication that would mask an Adverse Event (AE) or confound 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* (For Oxaprozin and Piroxicam consider 2 weeks before visit 1).
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- 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.
- Is currently using or has used any facial products containing acne active ingredients (e.g. benzoyl peroxide, salicylic acid, etc.) within the past 2 weeks or longer, if in the opinion of the Study Physician this could interfere with study results;
- Aesthetic or dermatologic treatment, invasive or non-invasive, in the test areas within 2 weeks prior to the start of the study and during the study;
- Subjects who reported being pregnant, or planning to become pregnant during the study;
- Using any medication to treat diseases of the face or eyes;
- Use of any other products capable of interfering with the study evaluations, at the discretion of the dermatologist;
- Subjects who have hormonal dysfunction that may influence the study results, at the discretion of the attending physician (for example, subjects with a history of irregular menstruation, polycystic ovary syndrome, users of anabolic steroids, and/or medication for hormone treatment, etc);
- Moderate to severe acne skin, confirmed by a dermatologist;
- Has a history of or a concurrent health condition/situation that may put the individual at significant risk, confound the study results, or interfere significantly with the individual's participation in the study;
- Has washed their face less than 2 hours before the study assessments;
- Excessive hair in the assessment area that could interfere with visual measurements. In the case of men, even in the presence of excessive hair in the beard area, they will be instructed to shave 24 hours before the visit;
- Simultaneously taking part in another study;
- Being an employee/contractor or close relative of the PI, Study Site, or Sponsor.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Allergisa Pesquisa Dermato-Cosmética Ltda
Campinas, São Paulo, 13084-791
About this study
Official title: A Single Center, Open-Label, Non-Randomized, Safety in Use Clinical Study to Assess The Topical Tolerability, Comedogenic and Acnegenic Potential, and Efficacy in Inflammatory and Non-Inflammatory Acne Vulgaris of a Sunscreen in Adult Subjects With Oily and Combination, Acne-Prone Skin
The purpose of this trial is to evaluate 1) To assess the dermatological tolerability and the absence of acnegenic and comedogenic potential of 1 facial sunscreen, after 28 ± 2 days of use under normal conditions by adult subjects with acne prone skin, 2) To assess the clinical efficacy of the topical product in inflammatory and non-inflammatory acne vulgaris, and in the reduction of post-inflammatory erythema (PIE) and post-inflammatory hyperpigmentation (PIH) spots, under normal conditions of use; 3) Facial image capture with the VISIA-CR® Analysis System (Canfield Scientific, Inc.) equipment, to analyze acne marks and record before and after; 4)Assessment of perception by the study subject through Self-Perceived Effectiveness questionnaires and satisfaction surveys (emotional testimony).
- Conditions
- Acne Vulgaris
- Being tested
- Sunscreen SPF 70
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sunscreen SPF 70Other
Participants will topically apply sunscreen SPF 70
| Study group | Role | What they receive |
|---|---|---|
| Sunscreen | Experimental | Eligible study participants will visit the Site for an initial evaluation of skin condition and receive the Sunscreen to be used at home. Next, participants will use the Sunscreen in normal conditions at home for 28 +/- 2 days, returning to the Site after 7 days of product use, then make the last study visit to complete the final analysis. Receives: Other: Sunscreen SPF 70 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 28 days
Topical tolerability as assessed by the dermatologist
Topical tolerability will be assessed using skin reaction intensity evaluation scale. Skin Reaction Intensity Evaluation Scale is a composite evaluation of any irritation/reaction subscoring for erythema, peeling, vesiculation, and edema. The scale ranges from 0=absent to 4=intense.
Measured: Baseline, Day 7 and Day 28 +/- 2 days
Number of Participants with Improvement from Baseline in Acne and Comedones
The comedogenic and acnegenic potential will be evaluated by comparing the final acne lesion counts (D28) with the baseline acne lesion counts. The lesions will be classified as closed comedones (whiteheads), open comedones (blackheads), pustules (pustules) and papules (papules). The lesions will be counted in 05 areas of the face: 02 in the frontal region, 02 in the malar region and chin, papules and pustules will be counted on the entire face (except the nose).
Measured: Baseline, Day 7 and Day 28 +/- 2 days
Change from Baseline in Clinical Effectiveness Assessment on Post-Inflammatory Hyperpigmentation
Change from Baseline in Clinical Effectiveness Assessment on Post-Inflammatory Hyperpigmentation (PIH) will be reported. A 10-point ordinal scale (0 to 9) will be used. Therefore, as it is an ordinal scale, the intermediate points do not have an established definition. For PIH, the evaluated area will be the Global Face and the scale to be used is defined from 0 = None, uniform skin color with no observable hyperpigmentation to 9 = Severe/highly visible, deep color difference.
Measured: Baseline, Day 7 and Day 28 +/- 2 days
Change from Baseline in Clinical Effectiveness Assessment on Post-Inflammatory Erythema
Change from Baseline in Clinical Effectiveness Assessment on Post-Inflammatory Erythema (PIE) will be reported. A 10-point ordinal scale (0 to 9) will be used. Therefore, as it is an ordinal scale, the intermediate points do not have an established definition. For PIE, the evaluated area will be the Global Face and the scale to be used is defined from 0 = None, skin color without observable erythema to 9 = Severe/Highly visible, color difference between skin and spot intense.
Measured: Baseline, Day 7 and Day 28 +/- 2 days
Number of Participants with Improvement From Baseline in Acne Mark Attributes Assessed Using the Visia-CR Facial Imaging Booth
Facial images will be captured using the Visia CR Facial Imaging Booth. Three Three images per participant will be captured: right lateral, left lateral and frontal using using the Cross Polarized, Standard 2 and RBX (Red) filters. The captured images will be further analyzed using specific image analysis software to evaluate the reduction in acne, improvement in PIE and PIH, reduction in acne marks.
Measured: Baseline, Day 7 and Day 28 +/- 2 days
Participant's Self-perceived Questionnaire to Assess the Clinical Effectiveness of the Sunscreen on Day 7
Participant's self-perceived questionnaire to assess the clinical effectiveness of the sunscreen on Day 7 will be reported. Participants will answer 11 questions and rate as: totally disagree, disagree, neither agree nor disagree, agree and totally agree.
Measured: Day 7
Participant's Self-perceived Questionnaire to Assess the Clinical Effectiveness of the Sunscreen on Day 28
Participant's self-perceived questionnaire to assess the clinical effectiveness of the sunscreen on Day 28 will be reported. Participants will answer 11 questions and rate as: totally disagree, disagree, neither agree nor disagree, agree and totally agree.
Measured: Day 28 +/- 2 days
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: End of the study (Day 28 +/- 2 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start9 May 2024
- Primary completion18 Jun 2024
- Study completion18 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- JNTL Consumer Health (Brasil) LTDA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gabrielli Brianezi, PhD, Principal investigator, Johnson & Johnson Consumer Inc. (J&JCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06544889
- Sponsor's protocol ID
- CS2024SK100019
- Status last verified
- Aug 2024
- First submitted
- 5 Aug 2024
- Last updated
- 15 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Open-Label, Non-Randomized, Safety in Use Clinical Study to Assess The Topical Tolerability, Comedogenic and Acnegenic Potential, and Efficacy in Inflammatory and Non-Inflammatory Acne Vulgaris of a Sunscreen in Adult Subjects With Oily and Combination, Acne-Prone Skin
- ClinicalTrials.gov ID
- NCT06544889
- Acronym / sponsor ID
- CS2024SK100019
- Conditions
- Acne Vulgaris
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- JNTL Consumer Health (Brasil) LTDAIndustry (pharma, biotech, devices)
- Study start
- 9 May 2024 (actual)
- Primary completion
- 18 Jun 2024 (actual)
- Study completion
- 18 Jun 2024 (actual)
- First posted
- 9 Aug 2024 (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.
The purpose of this trial is to evaluate 1) To assess the dermatological tolerability and the absence of acnegenic and comedogenic potential of 1 facial sunscreen, after 28 ± 2 days of use under normal conditions by adult subjects with acne prone skin, 2) To assess the clinical efficacy of the topical product in inflammatory and non-inflammatory acne vulgaris, and in the reduction of post-inflammatory erythema (PIE) and post-inflammatory hyperpigmentation (PIH) spots, under normal conditions of use; 3) Facial image capture with the VISIA-CR® Analysis System (Canfield Scientific, Inc.) equipment, to analyze acne marks and record before and after; 4)Assessment of perception by the study subject through Self-Perceived Effectiveness questionnaires and satisfaction surveys (emotional testimony).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sunscreen | Experimental | Other: Sunscreen SPF 70Eligible study participants will visit the Site for an initial evaluation of skin condition and receive the Sunscreen to be used at home. Next, participants will use the Sunscreen in normal conditions at home for 28 +/- 2 days, returning to the Site after 7 days of product use, then make the last study visit to complete the final analysis. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- Men and/or Women;
- 18 to 55 years old;
- Subjects vaccinated against COVID-19;
- Subjects of all ethnicities according to IBGE criteria - IBGE-The Brazilian Institute of Geography and Statistics;
- Phototypes I to IV according to the Fitzpatrick classification;
Key exclusion criteria (19 listed)
- Has known allergies or adverse reactions to common topical skin care products including sunscreens; medications, or other products that the investigator deems relevant;
- Presents a skin condition that may confound the study results (specifically psoriasis, eczema, atopic dermatitis, cutaneous xerosis, erythema, or active skin cancer);
- Has self-reported Type 1 or Type 2 diabetes or is taking insulin or another anti-diabetic medication;
- Is taking a medication that would mask an Adverse Event (AE) or confound the study results, including:
- Is currently using or has used any facial products containing acne active ingredients (e.g. benzoyl peroxide, salicylic acid, etc.) within the past 2 weeks or longer, if in the opinion of the Study Physician this could interfere with study results;
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 SPF 70Participants will topically apply sunscreen SPF 70 | Other | Sunscreen |
Primary outcome
Number of participants with adverse events
Time frame: Up to 28 days
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.
Topical tolerability as assessed by the dermatologist
Time frame: Baseline, Day 7 and Day 28 +/- 2 days
Topical tolerability will be assessed using skin reaction intensity evaluation scale. Skin Reaction Intensity Evaluation Scale is a composite evaluation of any irritation/reaction subscoring for erythema, peeling, vesiculation, and edema. The scale ranges from 0=absent to 4=intense.
Number of Participants with Improvement from Baseline in Acne and Comedones
Time frame: Baseline, Day 7 and Day 28 +/- 2 days
The comedogenic and acnegenic potential will be evaluated by comparing the final acne lesion counts (D28) with the baseline acne lesion counts. The lesions will be classified as closed comedones (whiteheads), open comedones (blackheads), pustules (pustules) and papules (papules). The lesions will be counted in 05 areas of the face: 02 in the frontal region, 02 in the malar region and chin, papules and pustules will be counted on the entire face (except the nose).
Change from Baseline in Clinical Effectiveness Assessment on Post-Inflammatory Hyperpigmentation
Time frame: Baseline, Day 7 and Day 28 +/- 2 days
Change from Baseline in Clinical Effectiveness Assessment on Post-Inflammatory Hyperpigmentation (PIH) will be reported. A 10-point ordinal scale (0 to 9) will be used. Therefore, as it is an ordinal scale, the intermediate points do not have an established definition. For PIH, the evaluated area will be the Global Face and the scale to be used is defined from 0 = None, uniform skin color with no observable hyperpigmentation to 9 = Severe/highly visible, deep color difference.
Change from Baseline in Clinical Effectiveness Assessment on Post-Inflammatory Erythema
Time frame: Baseline, Day 7 and Day 28 +/- 2 days
Change from Baseline in Clinical Effectiveness Assessment on Post-Inflammatory Erythema (PIE) will be reported. A 10-point ordinal scale (0 to 9) will be used. Therefore, as it is an ordinal scale, the intermediate points do not have an established definition. For PIE, the evaluated area will be the Global Face and the scale to be used is defined from 0 = None, skin color without observable erythema to 9 = Severe/Highly visible, color difference between skin and spot intense.
Number of Participants with Improvement From Baseline in Acne Mark Attributes Assessed Using the Visia-CR Facial Imaging Booth
Time frame: Baseline, Day 7 and Day 28 +/- 2 days
Facial images will be captured using the Visia CR Facial Imaging Booth. Three Three images per participant will be captured: right lateral, left lateral and frontal using using the Cross Polarized, Standard 2 and RBX (Red) filters. The captured images will be further analyzed using specific image analysis software to evaluate the reduction in acne, improvement in PIE and PIH, reduction in acne marks.
Participant's Self-perceived Questionnaire to Assess the Clinical Effectiveness of the Sunscreen on Day 7
Time frame: Day 7
Participant's self-perceived questionnaire to assess the clinical effectiveness of the sunscreen on Day 7 will be reported. Participants will answer 11 questions and rate as: totally disagree, disagree, neither agree nor disagree, agree and totally agree.
Participant's Self-perceived Questionnaire to Assess the Clinical Effectiveness of the Sunscreen on Day 28
Time frame: Day 28 +/- 2 days
Participant's self-perceived questionnaire to assess the clinical effectiveness of the sunscreen on Day 28 will be reported. Participants will answer 11 questions and rate as: totally disagree, disagree, neither agree nor disagree, agree and totally agree.
Testimonial Regarding the Experience with Sunscreen
Time frame: End of the study (Day 28 +/- 2 days)
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.
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 15 Aug 2024.
- 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.
Gabrielli Brianezi, PhD principal investigator
Johnson & Johnson Consumer Inc. (J&JCI)
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 SPF 70 in people with Acne Vulgaris, run by JNTL Consumer Health (Brasil) LTDA 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 16 inclusion and 19 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 15 Aug 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?
Number of participants with adverse events (time frame: Up to 28 days). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2024.