ClinicalTrials.gg
RecruitingNCT07789639Updated Aug 27, 2026

A 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

A Phase 4 interventional study of Hybrid sunscreen and Chemical sunscreen in Epidermis and Ultraviolet Exposure, sponsored by Good Molecules, LLC. Recruiting at 1 site in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-27.

Sponsored by Good Molecules, LLC · Phase 4, Interventional, and Basic science

Phase
Phase 4
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Epidermis
  • Ultraviolet Exposure

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Keywords

  • SPF
  • Ultraviolet Radiation
  • Erythema
03

In context

Erythema

131 studies on the registry are indexed under Erythema; 17 are open to participants now.

This study's planned enrollment of 60 is above the median of 50 across 114 interventional studies indexed under Erythema.

Browse Erythema studies →

Lead sponsor

Good Molecules, LLC is the lead sponsor of 4 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Subject is male or female between 18 - 75 years old, providing legally effective, written 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

Exclusion Criteria:

  • Female subject is pregnant, nursing, planning a pregnancy, or using inadequate
  • 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 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. , STD's, , , 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).
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

05

Study design

Phase
Phase 4
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Single group
Masking
Double (Participant, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Placebo comparator
    No SPF Placebo

    Other: No sunscreen

  • Experimental
    Test Product

    Drug: Hybrid sunscreen

  • Active comparator
    Benchmark

    Drug: Chemical sunscreen

Interventions

  • DrugHybrid sunscreen

    Hybrid D II SPF 30

  • DrugChemical sunscreen

    Chemical SPF 30

  • OtherNo sunscreen

    No SPF Placebo

06

What researchers measure

Primary outcomes

  1. Chromameter

    This study will use a reflectance colorimeter, CM-700d (Konica Minolta) or equivalent, a handheld device that measures skin color in the L\*a\*b\* color space. The L\*, a\*, and b\* values will be measured from at least 3 different locations on the subject's back and then used to calculate the ITA°, which can be used to estimate a subject's MEDu

    Time frame: Chromameter measurements will be obtained at Day 1 Baseline and Day 3 post treatment

  2. Dermal Darkening Evaluation

    A technician will determine post UV dose immediate responses using the assessment scale listed below: Table 4. Immediate Response Codes N No Immediate response D Immediate Darkening R Immediate Reddening H Immediate Generalized Heat Response Spreading Beyond the Subsite

    Time frame: Baseline and Day 3 Post-treatment

  3. Erythema Dermal Evaluation

    Table 5. Grading Scale for Erythema Responses to UV Doses Administered to Untreated Sites and Sunscreen-Treated Sites 0 = No erythema response or inconclusive response 0.5 = Ambiguous erythema and/or no clear border and/or not filling more than 50% of the exposure subsite. (Minimally perceptible erythema) 1. = Perceptible unambiguous erythema with clearly defined borders (filling more than 50% of the exposure subsite) 2. = Moderate to intense erythema

    Time frame: Baseline and Day 3 Post-treatment

  4. Mexameter

    Three Mexameter measurements will be obtained from the subjects randomized test sites on the back at each designated time point to assess erythema and melanin.

    Time frame: Baseline and Day 3 Post-treatment

  5. Dermal interstitial fluid

    Client-provided human interstitial fluid samples and commercially-sourced artificial interstitial fluid will be evaluated at multiple dilutions for levels of IL-1α, IL-6, IL-8, and VEGF-A using Luminex methodology (Thermo Fisher ProcartaPlex catalog #PPXT-04). Two (2) client-provided human interstitial fluid samples will be evaluated at 8 dilutions in singlicate.

    Time frame: At the Baseline timepoint, a sub-site to the top left of the testing area will be used for the micro-needling.

Secondary outcomes

  1. Thermometer reading

    A Fisher brand IR Thermometer will be used to obtain the subjects skin temperature from the following test sites: Untreated area, and for the areas treated with No SPF Placebo, Hybrid SPF 30, and Chemical Benchmark SPF 30 before and after UV Exposure.

    Time frame: Right before and immediately after UV Exposure.

07

Study locations

1 of 1 sites recruiting
  • Eurofins | CRL, Cosmetics LLC
    Winston-Salem, North Carolina 27101, United States
    Recruiting
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07789639
Lead sponsor
Good Molecules, LLC
Collaborators
Eurofins CRL Cosmetics, Inc.
Responsible party
Sponsor
First posted
Aug 27, 2026
Start date
Sep 14, 2026 (estimated)
Primary completion
Feb 24, 2027 (estimated)
Completion
Apr 7, 2027 (estimated)
Last update
Aug 27, 2026

Study contacts

Alexis Chantal, PA-C
Contact
Alexis.Chantal@cpt.eurofinsus.com
(336) 725-6501

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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