EpidermisPhase 4NCT07789639

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 study testing Hybrid sunscreen, Chemical sunscreen and No sunscreen in people with Epidermis and Ultraviolet Exposure, run by Good Molecules, LLC at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Epidermis, Ultraviolet Exposure
What is being tested?: Hybrid sunscreen, Chemical sunscreen and No sunscreen
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 60 participants
Where: 1 siteUnited States
Study dates: 14 Sep 2026to 7 Apr 2027
Phase: Phase 4
Are there results?: Not yet: the study is under way

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 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Show all 14Show fewer

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

Who cannot join

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

Show all 17Show fewer

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).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Alexis Chantal, PA-C contact

(336) 725-6501

Alexis.Chantal@cpt.eurofinsus.com

United States1 site, 1 recruiting

Eurofins | CRL, Cosmetics LLC
Winston-Salem, North Carolina, 27101
Chelcie Mejia, (336) 725-6501, Chelcie.Mejia@cpt.eurofinsus.com
Recruiting

Other trials in United States

About this study

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

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
Being tested: Hybrid sunscreen, Chemical sunscreen, No sunscreen
Keywords: SPF, Ultraviolet Radiation, Erythema
Medical subject headings: Erythema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Hybrid sunscreenDrug
Hybrid D II SPF 30
Chemical sunscreenDrug
Chemical SPF 30
No sunscreenOther
No SPF Placebo

Study groups in NCT07789639
Study group	Role	What they receive
No SPF Placebo	Placebo comparator	Not described Receives: Other: No sunscreen
Test Product	Experimental	Not described Receives: Drug: Hybrid sunscreen
Benchmark	Active comparator	Not described Receives: Drug: Chemical sunscreen

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Chromameter measurements will be obtained at Day 1 Baseline and Day 3 post treatment
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
Measured: Baseline and Day 3 Post-treatment
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
Measured: Baseline and Day 3 Post-treatment
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.
Measured: Baseline and Day 3 Post-treatment
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.
Measured: 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.
Measured: Right before and immediately after UV Exposure.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Sep 20267 Apr 2027

First posted27 Aug 2026
Study start14 Sep 2026 (estimated)
Primary completion24 Feb 2027 (estimated)
Study completion7 Apr 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for EpidermisStudies 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 4
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Single group
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 60 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07789639
Sponsor's protocol ID: ECRLNC2026-0016 PB
Status last verified: Aug 2026
First submitted: 14 Aug 2026
Last updated: 27 Aug 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT07789639
Acronym / sponsor ID: ECRLNC2026-0016 PB
Conditions: Epidermis, Ultraviolet Exposure
Keywords: SPF, Ultraviolet Radiation, Erythema
Phase: Phase 4
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 60 participants (estimated)
Lead sponsor: Good Molecules, LLCIndustry (pharma, biotech, devices)
Collaborators: Eurofins CRL Cosmetics, Inc.
Study start: 14 Sep 2026 (estimated)
Primary completion: 24 Feb 2027 (estimated)
Study completion: 7 Apr 2027 (estimated)
First posted: 27 Aug 2026 (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.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Single group
Masking: Double blind (participant, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
No SPF Placebo	Placebo comparator	Other: No sunscreen
Test Product	Experimental	Drug: Hybrid sunscreen
Benchmark	Active comparator	Drug: Chemical sunscreen

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (14 listed)

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

Key exclusion criteria (17 listed)

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

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
Hybrid sunscreenHybrid D II SPF 30	Drug	Test Product
Chemical sunscreenChemical SPF 30	Drug	Benchmark
No sunscreenNo SPF Placebo	Other	No SPF Placebo

Primary outcome

Chromameter
Time frame: Chromameter measurements will be obtained at Day 1 Baseline and Day 3 post treatment
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
Dermal Darkening Evaluation
Time frame: Baseline and Day 3 Post-treatment
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
Erythema Dermal Evaluation
Time frame: Baseline and Day 3 Post-treatment
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
Mexameter
Time frame: Baseline and Day 3 Post-treatment
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.
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.
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.

1 secondary outcome

Thermometer reading
Time frame: Right before and immediately after UV Exposure.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
Individual participant dataSharing planned: No

Related trials for Epidermis

Active, not recruitingPhase 3
Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)
Non-small Cell Lung Cancer (NSCLC)
RecruitingPhase 1
A Study With NKT3964 for Adults With Advanced/Metastatic Solid Tumors
Solid Tumor, Advanced Solid Tumor
Active, not recruitingPhase 3
A Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Characterized by Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions
Carcinoma, Non-Small-Cell Lung
Active, not recruitingPhase 3
A Study of DZD9008 Versus Platinum-Based Doublet Chemotherapy in Local Advanced or Metastatic Non-small Cell Lung Cancer (WU-KONG28)
Non-small Cell Lung Cancer
RecruitingPhase 3
Adding an Immunotherapy Drug, MEDI4736 (Durvalumab), to the Usual Chemotherapy Treatment (Paclitaxel, Cyclophosphamide, and Doxorubicin) for Stage II-III Breast Cancer
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8

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.

Alexis Chantal, PA-C contact

(336) 725-6501

Alexis.Chantal@cpt.eurofinsus.com

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Hybrid sunscreen, Chemical sunscreen and No sunscreen in people with Epidermis and Ultraviolet Exposure, run by Good Molecules, LLC at 1 site in United States.

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 14 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 27 Aug 2026. 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 United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Alexis Chantal, PA-C ((336) 725-6501, Alexis.Chantal@cpt.eurofinsus.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Chromameter (time frame: Chromameter measurements will be obtained at Day 1 Baseline and Day 3 post treatment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07789639.

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 27 Aug 2026.