Clinical trial Recruiting at 1 site Phase 4 Interventional Ages 18 to 75

Test materials for SPF protection across light and dark skin groups

Official title: A Clinical Study to Evaluate the Interstitial Dermal Fluid, Efficacy and Sun Protection Factor (SPF) of Two Test Materials According to an Adaptation of the Guidelines of the FDA Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use

Run by Good Molecules, LLC · NCT07789639 · Data updated 2026-11-12

This study tests two SPF products, a placebo, and standard sunscreen to see how well they protect different skin types from UV-induced redness.

Quick facts

PhasePhase 4
Study typeInterventional
Ages18 Years to 75 Years
SexAll
Enrollment60 (estimated)
SponsorGood Molecules, LLC
Industry-sponsored
Drugs / interventionsradiation
Locations1 site (Winston-Salem, North Carolina)
StatusRecruiting
StartedSeptember 14, 2026
Main results expectedFebruary 24, 2027
Study endsApril 7, 2027
Registry record updatedAugust 27, 2026
Trial IDNCT07789639 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 18–75 with Fitzpatrick skin types I–VI, willing to undergo back micro-needling and to avoid UV exposure during the study.

Probably not a fit

Individuals outside the specified skin-type distribution or those unwilling to participate in UV protection protocols or back micro-needling may not benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this Phase 4 interventional study, about 70 adults with Fitzpatrick skin types I–VI will receive light and dark skin treatments, with a subset undergoing micro-needling. Participants will be exposed to a known UV dose, and protective effects of two test SPF materials, a placebo, and a standard sunscreen will be compared using measurements such as SPF determination, erythema assessment, chromameter and mexhameter readings, digital photography, temperatures, and interstitial dermal fluid analysis. The study aims to characterize protection across skin types before and after UV exposure.

Why it matters

Potential benefit: If successful, the SPF test materials could offer effective protection across diverse skin types.

How similar studies have gone: Prior sunscreen studies have demonstrated measurable differences in protection by skin type, supporting the potential value of this approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
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).

Where it's running

  • Eurofins | CRL, Cosmetics LLC
    Winston-Salem, North Carolina, United States
    Recruiting

Study contacts

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.