Clinical trial NCT05864417: A Study to Assess Effect of Two Facial Sunscreens in Improving Wrinkles, Fine Lines and Melasma in Adult Participants
Official title: A Single-Center, Open-Label, Safety in Use Clinical Study to Assess Topical Tolerability and Efficacy in Improving Wrinkles, Fine Lines, and Melasma After 84 ± 2 Days of Use of Two Facial Sunscreens in Adult Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2023-05-18
Enrollment: 40
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate the topical safety (tolerability/acceptability) and efficacy of two facial sunscreen in improving wrinkles, fine lines and melasma after 84 +/- 2 days of use under normal conditions on the face by adult participants. For these investigational products, safety parameters, clinical efficacy, instrumental efficacy (assessment of color intensity and size of melasma spots and assessment of wrinkles and fine lines), facial imaging, and self-perceived efficacy through subjective questionnaire and quality of life questionnaires (MELASQol) will be evaluated, as well as an open emotional statement written by the participant at the end of use experience".


Eligibility criteria: Inclusion Criteria:

* Male and/or Female
* Participants of any ethnicity according to IBGE criteria
* From 35 years of age
* Fitzpatrick Skin Type II to IV
* Participant presenting mild to moderate melasma (grade 1 to 2 - according to the Site's scale), proven by a dermatologist
* Participant's presenting wrinkles/fine lines in any region of the face (periorbital, frontal and/or nasolabial) from grade 2 to 6 (according to the Site's scale), confirmed by the dermatologist
* Generally in good health based on medical history reported by the participant
* Able to read, write, speak, and understand Portuguese
* For Male Participants: agree to shave 24 hours before visits 1 to 4
* Individual has signed the following informed consent documents (ICD):ICD, Informed Consent Image Disclosure (ICID) e Informed Consent for Cession of Rights for Image Use (ICCRIU)
* Intends to complete the study and is willing and able to follow all study instructions

Exclusion Criteria:

* Has known allergies or adverse reactions to common topical skincare products including sunscreen
* Presents with a skin condition that may confound the study results (specifically psoriasis, eczema, atopic dermatitis, cutaneous xerosis, erythema, or active skin cancer)
* Presents with primary/secondary lesions (example scars, ulcers, vesicles) or tattoos on test sites
* Participants with immune deficiency
* 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, 2; non-steroidal anti-inflammatory drugs within 5 days before Visit 1; antihistamines within 2 weeks before Visit 1
* Start or change of hormone replacement therapy or contraceptive drug method in the last 03 months
* Participants who are using or have used topical products such as Retin-A, Retin-A Micro, and Differin or any other topical retinoid on the face within 6 months prior to the study; or use of any oral retinoid within 1 year prior to the study
* Participants who are using or have currently used any facial products containing active ingredients against spots and/or wrinkles: 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 'anti-aging' products or products capable of interfering with skin brightness/uniformity, or with spots, within 2 months prior to the start of the study
* Participants who have used cosmetic products on the same area (face) with anti-spot and anti-wrinkle action, within 14 days before the beginning of the study
* Participants who have undergone chemical and/or physical peeling, laser or similar aesthetic treatments within 6 months prior to the study
* Participants who have undergone invasive cosmetic or dermatological treatment in the test area within 2 months before the start of the study or during the study
* Intense sun exposure or tanning session up to 01 month before the initial evaluation or planned intense sun exposure or tanning session during the study
* Present signs of intense tanning, according to the evaluation of the study physician
* 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 may put the individual at significant risk, confound the study results, or interfere significantly with the individual's participation in the study
* Present excessive hair in the evaluation region that may interfere in the instrumental measurements. In the case of men, even in the presence of excessive hair in the beard region, they will be instructed to shave one day before the visit
* Is simultaneously participating in any other clinical study;
* Is an employee/contractor or immediate family member of the principal investigator (PI), Study Site, or Sponsor

Primary outcomes:
measure: Number of Participants with Adverse Events
timeFrame: Up to 84 +/- 2 days
measure: Improvement in Assessment of Melasma Color Intensity Using Chroma Meter CR 400 at Day 28
timeFrame: Baseline and Day 28
measure: Improvement in Assessment of Melasma Color Intensity Using Chroma Meter CR 400 at Day 56
timeFrame: Baseline and Day 56
measure: Improvement in Assessment of Melasma Color Intensity Using Chroma Meter CR 400 at Day 84 +/- 2
timeFrame: Baseline and Day 84 +/- 2
measure: Number of Participants with Improvement From Baseline in Melasma, and Wrinkles and Fine lines Assessed Using the Visia-CR Facial Imaging Booth at Day 28
timeFrame: Baseline and Day 28
measure: Number of Participants with Improvement From Baseline in Melasma, and Wrinkles and Fine lines Assessed Using the Visia-CR Facial Imaging Booth at Day 56
timeFrame: Baseline and Day 56
measure: Number of Participants with Improvement From Baseline in Melasma, and Wrinkles and Fine lines Assessed Using the Visia-CR Facial Imaging Booth at Day 84 +/- 2
timeFrame: Baseline and Day 84 +/- 2
measure: Number of Participants With Improvement From Baseline in Quality of Life as Assessed by the Melasma Quality of Life Scale (MELASQOL) at Day 28
timeFrame: Day 28
measure: Number of Participants With Improvement From Baseline in Quality of Life as Assessed by the Melasma Quality of Life Scale (MELASQOL) at Day 56
timeFrame: Day 56
measure: Number of Participants With Improvement From Baseline in Quality of Life as Assessed by the Melasma Quality of Life Scale (MELASQOL) at Day 84 +/- 2
timeFrame: Day 84 +/- 2
measure: Participant's Self-perceived Questionnaire to Assess their Perception of the Color/Tone of Sunscreen
timeFrame: Baseline (Day 1)
measure: Participant's Self-perceived Questionnaire to Assess the Clinical Effectiveness of the Sunscreen on Day 28
timeFrame: Day 28
measure: Participant's Self-perceived Questionnaire to Assess the Clinical Effectiveness of the Sunscreen on Day 84 +/- 2
timeFrame: Day 84 +/- 2
measure: Testimonial Regarding the Experience with Sunscreen
timeFrame: End of the Study (84 +/- 2 days)
measure: Topical Tolerability as Assessed by the Dermatologist
timeFrame: Up to 84 +/- 2 days
measure: Number of Participants with Improvement From Baseline in Melasma by mMASI Scale as Assessed by the Dermatologist
timeFrame: Up to 84 +/- 2 days
measure: Clinical Efficacy Evaluations as Assessed by the Dermatologist on Day 28
timeFrame: Day 28
measure: Clinical Efficacy Evaluations as Assessed by the Dermatologist on Day 56
timeFrame: Day 56
measure: Clinical Efficacy Evaluations as Assessed by the Dermatologist on Day 84 +/- 2
timeFrame: Day 84 +/- 2
Secondary outcomes:
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: Allergisa Pesquisa Dermato-Cosmética Ltda
state: Sao Paulo
Study officials:
affiliation: Johnson & Johnson Consumer Inc. (J&JCI)
name: Gabrielli Brianezi
role: PRINCIPAL_INVESTIGATOR
References: