Recruiting

SPF Test MaterialsA Clinical Study to Evaluate the Efficacy and SPF of Two Test Materials According to an Adaptation of the Guidelines of the FDA Sunscreen Drug Products for Over-the-Counter Human Use

Sponsor:

Good Molecules, LLC

Code:

NCT07789639

Conditions

Epidermis

Ultraviolet Exposure

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Hybrid sunscreen

Chemical sunscreen

No sunscreen

Study Details

Brief summary:

Approximately 70 subjects (35 subjects per light and dark group) will be enrolled in this clinical study (to complete with a minimum of 10 subjects per skin type (I-VI) to assess the effects of known UV Radiation dosage on light and dark skin, assess the protective effect of two SPF test materials, placebo product, and standard sunscreen ('Pad O') on skin, before and after a known UV Radiation dosage and collect the interstitial dermal fluid from approximately 60 subjects and send to Eurofins Discovery for analysis. The following study evaluations will be obtained: SPF Determination, Visual Assessment of Erythema, Chromameter and Mexameter measurements, Digital photography, Thermometer readings and Collection of Dermal Interstitial Fluid (IDF).

Conditions

Epidermis

Ultraviolet Exposure

Study ID

NCT07789639

Start date

Sep 14, 2026

Status verified date

Aug, 2026

Completion date

Apr 7, 2027

Anticipated

Primary completion date

Feb 24, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

Subject is male or female between 18 - 75 years old, providing legally effective, written informed consent in conformance with 45 CFR Parts 160 and 164
Subject has a Fitzpatrick Skin Type of I, II, or III, Light Skin Group or IV, V, or VI Dark Skin Group with an approximately equal distribution of all skin types (approximately 10 of each Fitzpatrick skin type) within each group as determined by ITA Angle
Subject agrees to undergo the micro needling procedure on their back (a total of 5 sites)
Subject should not have their back shaved or waxed 3 days prior to the start of the study
Subject is able to read, write, speak, and understand English
Subject is in good general health
Subject agrees to avoid UV exposure to the test area for the duration of the study
Subject is willing to wear loose-fitting clothing that exposes mid to lower back for study visits
Subject is dependable and able to follow directions as outlined in the protocol and anticipates being available for all study visits
Subject is willing to participate in all study evaluations and follow all instructions
Subject has a current Subject Profile Form on file at ECRL
Subject has uniform skin color over the test area; ITA° calculation range ≤10-point difference (example: 35.6°-45.6°)
Subject agrees to sign a Photography Release Form, providing consent for the capture of digital images for use in relation to this clinical study
Subject has completed a HIPAA Authorization Form in conformance with 45 CFR Parts 160 and 164

Exclusion Criteria:

Female subject is pregnant, nursing, planning a pregnancy, or using inadequate birth control
Subject has a history of abnormal response to sunlight/UV radiation; sensitivity to any ingredient of the test materials, standard or latex; or any known allergies to sunscreen, cosmetic, and/or toiletry products
Subject has a history of or any current significant dermatological condition, such as atopic dermatitis (eczema), psoriasis, skin cancer, melanoma, active dermal lesions, nevi, keloids blemishes, abnormal scarring or moles, lupus, diabetes, or connective tissue disease that would increase the risk associated with participation
Subject has received treatment with sympathomimetics, antihistamines, vasoconstrictors, non-steroidal anti-inflammatory agents, and/or systemic or topical corticosteroids within one week prior to initiation of the study.
Subject has used a prohibited medication (per separately provided prohibited medication list) within the specified timeframes prior to initiation of the study
Subject has used/applied any personal care products (e.g. lotions, sunscreens, sunless tanners) and/or topical medications in/on the testing area (the back between the shoulder blades and the waist line) within 24 hours prior to Day 1 or during the study
Subject has any known communicable disease(s) (e.g. HIV, STD's, Hepatitis B, Hepatitis C, etc.)
Subject has any skeletal protrusions and/or extreme areas of curvature in the test area
Subject with medical treatment/vaccination planned during the study, which would make the subject ineligible, place the subject at undue risk, or confound the outcome of the study, per the discretion of the PI.
Subject has undergone any surgical procedure in the last 12 months
Subject has undergone chemical or physical treatment procedures in the test area within the last 12 months
Subject is planning hospitalization during the study
Subject exceeds the weight limit of 300 pounds due to equipment limitations
Subject has any condition that might confound the study results, increase the risk associated with participation, or interfere with study participation;
Subject has any visible sunburn or suntan in testing area
Subject has used an artificial tanning lamp or had recent sun exposure to the test area within the past 2 months
Subject has participated in another UV exposure clinical study in the last 2 months, or is currently enrolled in a clinical study utilizing the same test site (i.e., no back patches during a UV exposure study).

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

placebo comparator: No SPF Placebo

experimental: Test Product

active comparator: Benchmark

Interventions

Hybrid sunscreen

Hybrid D II SPF 30

Chemical sunscreen

Chemical SPF 30

No sunscreen

No SPF Placebo

Primary outcome measure

Chromameter [ Time Frame: Chromameter measurements will be obtained at Day 1 Baseline and Day 3 post treatment ]
Dermal Darkening Evaluation [ Time Frame: Baseline and Day 3 Post-treatment ]
Erythema Dermal Evaluation [ Time Frame: Baseline and Day 3 Post-treatment ]
Mexameter [ Time Frame: Baseline and Day 3 Post-treatment ]
Dermal interstitial fluid [ Time Frame: At the Baseline timepoint, a sub-site to the top left of the testing area will be used for the micro-needling. ]

Central Contacts and Locations

Central contacts

Alexis Chantal, PA-C

(336) 725-6501 Alexis.Chantal@cpt.eurofinsus.com

Locations

Eurofins | CRL, Cosmetics LLC

Recruiting

Winston-Salem, North Carolina, United States, 27101

Contacts

Chelcie Mejia

(336) 725-6501 Chelcie.Mejia@cpt.eurofinsus.com

More Information

Sponsor

Good Molecules, LLC

Last update posted

Aug 27, 2026

Last verified

Aug, 2026

Keywords

SPF
Ultraviolet Radiation
Erythema

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Good Molecules, LLC on 2026-08-27.