Sensitive SkinPhase 4NCT07811531
A Clinical Investigation of a Topical Moisturizer on Skin Barrier Function in Adults With Sensitive Skin
A Phase 4 study testing White petrolatum and Investigational moisturizer in people with Sensitive Skin, run by Good Molecules, LLC at 1 site in United States.
Trial summary
The purpose of this research study is to evaluate whether a marketed moisturizing cream can improve skin barrier function (how well the outer layer of the skin keeps moisture in and protects the skin), skin hydration, skin sensitivity, inflammatory biomarkers (proteins in the skin that can provide information about… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Sensitive Skin
- What is being tested?
- White petrolatum and Investigational moisturizer
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2026to 12 Jan 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged 18 to 55 years, inclusive, of any sex.
- Self-declared sensitive skin affecting the body, characterized by unpleasant sensations such as burning, stinging, itching, tingling, tightness, or irritation in response to products or environmental triggers.
- Must present a TEWL value ≥15 g/m2/h on a volar forearm at the screening visit (T-7).
- Approximately 40-60% of enrolled participants should have Fitzpatrick skin types I-III, and approximately 40-60% should have Fitzpatrick skin types IV-VI.
- Must agree to complete a minimum 7-day washout period prior to baseline.
- Must agree to avoid body skincare products, moisturizers, hydrating gels, or prohibited topical products on both forearms during washout.
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- Must agree to use sponsor-provided SPF 30 sunscreen on both forearms beginning at least 7 days before baseline and continuing throughout study participation.
- Must be willing and able to comply with all study requirements, including clinic visits, product use, questionnaires, and sample collection procedures.
- Must provide written informed consent prior to any study-specific procedure.
- Must be willing to apply study products twice daily (morning and evening) for 28 consecutive days and maintain diary compliance.
Who cannot join
- Pregnancy, breastfeeding, or planning pregnancy during the study.
- Active dermatologic disease on the forearms, visible scars, or tattoos that interfere with measurement.
- History of chronic inflammatory or autoimmune conditions (rheumatoid arthritis, lupus, psoriasis, IBD, ankylosing spondylitis, multiple sclerosis).
- Active cancer or cancer treatment within the past 5 years, with the exception of localized non-melanoma skin cancer.
- Diagnosis of primary or acquired immunodeficiency.
- Use of systemic corticosteroids (oral or injected) within 4 weeks pre-enrollment, or anticipated use during the study.
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- Use of biologics for inflammatory conditions within 12 weeks pre-enrollment (including TNF inhibitors, IL-17 inhibitors, IL-23 inhibitors, IL-4/IL-13 inhibitors, dupilumab, lebrikizumab, tralokinumab, JAK inhibitors, and IL-1 blockers).
- Use of systemic immunosuppressants within 8 weeks pre-enrollment (methotrexate, cyclosporine, mycophenolate, azathioprine, systemic tacrolimus).
- Use of systemic antibiotics within 4 weeks pre-enrollment, or anticipated use during the study.
- Regular use of oral NSAIDs (defined as more than 2 days per week on average) within 2 weeks pre-enrollment or anticipated regular use during the study. Occasional use for acute conditions is permitted with logging.
- Daily aspirin use, including low-dose aspirin for cardiovascular prophylaxis.
- Use of topical corticosteroids, calcineurin inhibitors, or other prescription anti- inflammatory topicals on the forearms within 4 weeks pre-enrollment.
- Use of topical retinoids, alpha hydroxy acids, beta hydroxy acids, or other active exfoliants on the forearms within 4 weeks pre-enrollment.
- Active smoking (including vaping and recent cessation within 6 months).
- Heavy alcohol use, defined as more than 8 drinks per week.
- Surgery under general anaesthesia within the past 4 weeks.
- Vaccination within 2 weeks pre-enrollment.
- Excessive UV exposure (sunbathing, tanning beds) within 4 weeks pre-enrollment.
- Enrolled in another clinical trial within the 4 weeks pre-enrollment or during the study period.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Sequential Skin
New York, New York, 10001
Dashi, PhD, +1 (646) 663-5260, clinical@sequential.bio
About this study
Official title: An Exploratory Clinical Investigation of a Topical Moisturizer on Skin Barrier Function, Inflammatory Biomarkers, and Skin Microbiome in Adults With Sensitive Skin
The purpose of this research study is to evaluate whether a marketed moisturizing cream can improve skin barrier function (how well the outer layer of the skin keeps moisture in and protects the skin), skin hydration, skin sensitivity, inflammatory biomarkers (proteins in the skin that can provide information about inflammation), and the skin microbiome (the microorganisms that naturally live on the skin) in adults with sensitive skin, when compared with a commonly used moisturizing ointment (White Petrolatum) a widely used occlusive ointment (an ointment that forms a protective layer over the skin to help reduce moisture loss).
Read the detailed description
This study is an exploratory, single-center, randomized, evaluator-blinded, contralateral-controlled clinical investigation designed to evaluate the effects of a sponsor-provided daily moisturizer on skin barrier function, hydration, inflammatory biomarkers, and skin microbiome composition in adults with sensitive skin. A total of 24 participants will be recruited, with a minimum of 20 participants expected to complete the study and be included in evaluable analyses. Participants will undergo a 7-day washout period followed by a 28-day treatment phase. Each participant will serve as their own control. One volar forearm will receive the investigational moisturizer and the contralateral forearm will receive an occlusive comparator control, White Petrolatum, USP.
- Conditions
- Sensitive Skin
- Being tested
- White petrolatum, Investigational moisturizer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
White petrolatumOther
Dose per Application: 6 full pumps per application to the assigned forearm.
Investigational moisturizerOther
Dose per Application: 6 full pumps per application to the assigned forearm.
| Study group | Role | What they receive |
|---|---|---|
| Occlusive comparator control | Placebo comparator | White Petrolatum, USP Receives: Other: White petrolatum |
| Investigational moisturizer | Experimental | Marketed Moisturizer Receives: Other: Investigational moisturizer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transepidermal Water Loss (TEWL)
Measured: Baseline and Day 28
Skin Hydration
Measured by MoistureMeterSC
Measured: Baseline and Day 28
Skin Surface pH
Measured: Baseline and Day 28
Protein Biomarkers
Collected by CuDerm Adhesive Tape Stripping
Measured: Baseline and Day 28
Skin Microbiome
Collected by swabs
Measured: Baseline and Day 28
Sensitive Scale-10 Questionnaire
Measured: Baseline and Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start14 Sep 2026 (estimated)
- Primary completion16 Dec 2026 (estimated)
- Study completion12 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensitive SkinStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Good Molecules, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sequential
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07811531
- Sponsor's protocol ID
- NLP- 990
- Status last verified
- Sep 2026
- First submitted
- 4 Sep 2026
- Last updated
- 10 Sep 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 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Investigation of a Topical Moisturizer on Skin Barrier Function, Inflammatory Biomarkers, and Skin Microbiome in Adults With Sensitive Skin
- ClinicalTrials.gov ID
- NCT07811531
- Acronym / sponsor ID
- NLP- 990
- Conditions
- Sensitive Skin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Good Molecules, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Sequential
- Study start
- 14 Sep 2026 (estimated)
- Primary completion
- 16 Dec 2026 (estimated)
- Study completion
- 12 Jan 2027 (estimated)
- First posted
- 10 Sep 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.
The purpose of this research study is to evaluate whether a marketed moisturizing cream can improve skin barrier function (how well the outer layer of the skin keeps moisture in and protects the skin), skin hydration, skin sensitivity, inflammatory biomarkers (proteins in the skin that can provide information about inflammation), and the skin microbiome (the microorganisms that naturally live on the skin) in adults with sensitive skin, when compared with a commonly used moisturizing ointment (White Petrolatum) a widely used occlusive ointment (an ointment that forms a protective layer over the skin to help reduce moisture loss).
Detailed description
This study is an exploratory, single-center, randomized, evaluator-blinded, contralateral-controlled clinical investigation designed to evaluate the effects of a sponsor-provided daily moisturizer on skin barrier function, hydration, inflammatory biomarkers, and skin microbiome composition in adults with sensitive skin. A total of 24 participants will be recruited, with a minimum of 20 participants expected to complete the study and be included in evaluable analyses. Participants will undergo a 7-day washout period followed by a 28-day treatment phase. Each participant will serve as their own control. One volar forearm will receive the investigational moisturizer and the contralateral forearm will receive an occlusive comparator control, White Petrolatum, USP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Occlusive comparator control | Placebo comparator | Other: White petrolatumWhite Petrolatum, USP |
| Investigational moisturizer | Experimental | Other: Investigational moisturizerMarketed Moisturizer |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Adults aged 18 to 55 years, inclusive, of any sex.
- Self-declared sensitive skin affecting the body, characterized by unpleasant sensations such as burning, stinging, itching, tingling, tightness, or irritation in response to products or environmental triggers.
- Must present a TEWL value ≥15 g/m2/h on a volar forearm at the screening visit (T-7).
- Approximately 40-60% of enrolled participants should have Fitzpatrick skin types I-III, and approximately 40-60% should have Fitzpatrick skin types IV-VI.
- Must agree to complete a minimum 7-day washout period prior to baseline.
Key exclusion criteria (19 listed)
- Pregnancy, breastfeeding, or planning pregnancy during the study.
- Active dermatologic disease on the forearms, visible scars, or tattoos that interfere with measurement.
- History of chronic inflammatory or autoimmune conditions (rheumatoid arthritis, lupus, psoriasis, IBD, ankylosing spondylitis, multiple sclerosis).
- Active cancer or cancer treatment within the past 5 years, with the exception of localized non-melanoma skin cancer.
- Diagnosis of primary or acquired immunodeficiency.
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 |
|---|---|---|
| White petrolatumDose per Application: 6 full pumps per application to the assigned forearm. | Other | Occlusive comparator control |
| Investigational moisturizerDose per Application: 6 full pumps per application to the assigned forearm. | Other | Investigational moisturizer |
Primary outcome
Transepidermal Water Loss (TEWL)
Time frame: Baseline and Day 28
Skin Hydration
Time frame: Baseline and Day 28
Measured by MoistureMeterSC
Skin Surface pH
Time frame: Baseline and Day 28
Protein Biomarkers
Time frame: Baseline and Day 28
Collected by CuDerm Adhesive Tape Stripping
Skin Microbiome
Time frame: Baseline and Day 28
Collected by swabs
Sensitive Scale-10 Questionnaire
Time frame: Baseline and Day 28
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 10 Sep 2026.
- Individual participant dataSharing planned: No
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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.
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 White petrolatum and Investigational moisturizer in people with Sensitive Skin, 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 10 inclusion and 19 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 10 Sep 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 Dashi, PhD (+1 (646) 663-5260, clinical@sequential.bio), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transepidermal Water Loss (TEWL) (time frame: Baseline and Day 28). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Sep 2026.