AcneNCT06097871
RCT of an Oral Acne Supplement for Adult Women
A study testing Skin Nutraceutical Supplement in people with Acne, run by Nutraceutical Wellness Inc. at 1 site in United States.
Trial summary
This study is to assess the efficacy and tolerability of an oral supplement in mild to moderate acne in adult females. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Acne
- What is being tested?
- Skin Nutraceutical Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2024to 25 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Females subjects 18-50 years of age.
- Subjects with mild to moderate (non-cystic) acne (8 inflammatory lesions, 10 non-inflammatory lesions).
- Subjects with an IGA score of 2-3
- Subjects with all skin types (normal, oily, etc.)
- Subjects with all Fitzpatrick skin types I-VI.
- Subjects who agree to use only the provided study skin cleansing, moisturizing, and sunscreen products during the study duration.
Show all 15Show fewer
- Subjects agree not to introduce any new colored cosmetics (lipsticks, eye shadows, facial foundations, blush, powder) on their face.
- No known medical conditions that, in the investigator's opinion, may interfere with study participation.
- Women of childbearing potential must be willing to use a form of birth control during the study. For the purpose of this study, the following are considered acceptable methods of birth control: oral contraceptives, Norplant®, Depo-Provera®, double barrier methods (e.g., condom and spermicide) and abstinence.
- Subjects are dependable and able to follow directions and willing to comply with the schedule of visits.
- Subjects in generally good physical and mental health.
- Able to read, write, speak, and understand English
- Individual (and/or his/her legally acceptable representative, as applicable) has signed the Consent for Photograph Release and ICD including Health Insurance Portability and Accountability Act (HIPAA) disclosure.
- Subject must avoid sun exposure.
- Subject must avoid professional or facial spa procedures during the study.
Who cannot join
- Any dermatological disorder, which in the investigator's opinion, may interfere with the accurate evaluation of the subject's skin characteristics, except for the study condition of acne.
- Subjects who are not willing to use the assigned skin care study products to their face as instructed and are not willing to take an oral acne supplement.
- Females who are pregnant, lactating, or planning to become pregnant during the study or within 30 days of study completion. (Subject must document her response in either the source documentation or informed consent/assent forms).
- Subject has a surgery and/or invasive medical procedure planned during the study.
- Subject has observable suntan, scars, nevi, tattoo, excessive hair (including beard, mustache, or goatee), or other dermal conditions on the face that could interfere with study evaluations or confound study results, as determined by the PI or designee.
- Subject has a history of or a concurrent health condition/situation which, in the opinion of the PI, if medically qualified, or study physician, may put the individual at significant risk, confound the study results, or interfere significantly with the individual's participation in the study.
Show all 27Show fewer
- Subject is an employee/contractor or immediate family member of the PI, Study Site, or Sponsor.
- Subjects with clinically significant unstable medical disorders.
- Subjects who are unwilling or unable to comply with the requirements of the protocol.
- Subjects with any known allergies or sensitivities to the study products.
- Subjects who have a history of a psychological illness or condition that would interfere with their ability to understand and follow the requirements of the study.
- Subjects who have acne nodules/cysts representative of severe acne.
- Subjects who are currently using, planning to use during the study or has used any of the following in the specified time range (based on subject report):
- 1 month prior to Visit 1: Prescription (oral or topically applied on the face) antibiotics, inhaled steroids (except those prescribed for allergies), or hormones (pre- or post-menopausal hormone-replacement therapy; insulin, etc.), or other medications that could make skin more sensitive or have an effect on the skin, as determined by the PI or designee. Oral contraceptives are acceptable.
- 1 month prior to Visit 1: Prescription medication for acne (e.g. doxycycline, minocycline, clindamycin, sulfamethoxazole and trimethoprim [Bactrim], tetracycline, erythromycin, azithromycin, or Vibramycin®)
- 1 month prior to Visit 1: Topical prescription retinoids (e.g. Retin-A®, Retin-A Micro®, Renova®, Adapalene, Tazarotene, Avita®, Tazorac®, Avage®, Differin®), azelaic acid, benzoyl peroxide, dapsone, sodium sulfacetamide, Epiduo®, or other similar prescription drug on the face
- 6 months prior to Visit 1: Accutane or other oral retinoid
- 2 weeks prior to Visit 1: Any of the following on the face:
- Light therapy
- OTC topical medications/products (including antiacne or antibacterial agents, topical anti-inflammatories, topical retinoids, etc.). Sunscreens (SPF) are acceptable.
- Subject is taking medications that would mask an adverse event (AE) or influence the study results, including:
- Immunosuppressive drugs and steroidal and/or non-steroidal anti-inflammatory drugs within 3 months before Visit 1 and during the study.
- Regular use of antihistamines within 1 month before Visit 1 and during the study.
- Subject has a history of or a concurrent health condition/situation, which in the opinion of the PI, if medically qualified, or Study Physician, may put the individual at significant risk, confound the study results, or interfere significantly with the individual's participation in the study.
- Subjects who are currently experiencing an acne flare.
- Subjects having started hormone replacement therapies (HRT) or hormones for birth control less than 3 months prior to the study entry or who plan on starting, stopping or changing doses of HRT or hormones for birth control during the study.
- Subjects taking any medication or supplement that has a known interaction with any of the study product ingredients, including but not limited to Berberine, which is associated with inhibition of CYP450 enzymes.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dermatology Consulting Services
High Point, North Carolina, 27262
About this study
Official title: A Double-Blinded, Randomized Control Evaluation of the Efficacy of an Oral Acne Supplement for Adult Women
This study is to assess the efficacy and tolerability of an oral supplement in mild to moderate acne in adult females.
Read the detailed description
This is a 12-week, single-center, placebo controlled double blind, randomized clinical trial in adult female subjects with mild to moderate non-cystic acne. Female subjects will be enrolled in this single site study to evaluate the efficacy of an oral acne supplement. Upon enrollment, subjects will be randomized to a treatment or a placebo group. Both the subject and the investigator will be blinded to the subject's group allocation. The objective of this research is to assess the efficacy and tolerability of an oral supplement in mild to moderate non-cystic acne in adult females when compared to a placebo.
- Conditions
- Acne
- Being tested
- Skin Nutraceutical Supplement, Placebo pill
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin Nutraceutical SupplementDietary supplement
The Skin Nutraceutical Supplement is made with Nutrafol's patented Synergen Skin Complex®, which is a blend of proprietary formulation of botanicals with potent anti-inflammatory, anti-stress adaptogenic, antioxidant and DHT-inhibiting properties combined to synergistically combat the multiple underlying factors that compromise skin health. These ingredients include Holy Basil, Maca, Curcumin, and Berberine in combination with other nutrients used to support skin health such as olive extract (20% hydroxytyrosol), konjac root (3% ceramides), vitamin A, B vitamins, and vitamin C.
Placebo pillOther
A placebo pill containing non-active ingredients
| Study group | Role | What they receive |
|---|---|---|
| Nutraceutical Dietary Supplement | Experimental | A novel nutraceutical skin supplement, scientifically formulated to specifically target the multiple underlying causes of acne in women. The supplement is comprised of primary and secondary ingredients, designed to improve skin from the inside out. Receives: Dietary Supplement: Skin Nutraceutical Supplement |
| Placebo | Placebo comparator | Oral supplement containing non-active ingredients. Receives: Other: Placebo pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in IGA at 12 weeks
The primary efficacy endpoint is the investigator assessed change from baseline to week 12 in facial acne IGA rating compared to placebo.
Measured: 12 weeks
Secondary outcomes (12)
Change in IGA at 4 weeks
Investigator assessed change from baseline to week 4 in facial acne IGA rating compared to placebo
Measured: 4 weeks
Change in IGA a 8 weeks
Investigator assessed change from baseline to week 8 in facial acne IGA rating compared to placebo
Measured: 8 weeks
Change in corneometry measurements at 4 weeks
Change in corneometry measurements from baseline to week 4 compared to placebo.
Measured: 4 weeks
Change in sebumeter measurements at 4 weeks
Change in sebumeter measurements from baseline to week 4 compared to placebo.
Measured: 4 weeks
Change in corneometry measurements at 8 weeks
Change in corneometry measurements from baseline to week 8 compared to placebo.
Measured: 8 weeks
Change in sebumeter measurements at 8 weeks
Change in sebumeter measurements from baseline to week 8 compared to placebo.
Measured: 8 weeks
Change in corneometry measurements at 12 week
Change in corneometry measurements from baseline to week 12 compared to placebo.
Measured: 12 weeks
Change in sebumeter measurements at 12 week
Change in sebumeter measurements from baseline to week 12 compared to placebo.
Measured: 12 weeks
Subject assessed improvement at week 4
Subject assessed improvement in using a self assessment questionnaire at week 4 compared to placebo.
Measured: 4 weeks
Subject assessed improvement at week 8
Subject assessed improvement in using a self assessment questionnaire week 8 compared to placebo.
Measured: 8 weeks
Subject assessed improvement at week 12
Subject assessed improvement using a self assessment questionnaire at week 12
Measured: 12 weeks
Product-Related Safety outcomes
Overall incidence of all study product-related adverse events reported during the study.
Measured: All visits until 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start15 Jan 2024
- Primary completion24 Jul 2024
- Study completion25 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AcneStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1-1 randomization to placebo or active treatment
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nutraceutical Wellness Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06097871
- Sponsor's protocol ID
- NW-CS-03
- Status last verified
- Sep 2024
- First submitted
- 16 Oct 2023
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Draelos Z, Harper J, Farris PK, Hazan A, Raymond I. A 12-Week Randomized, Double-Blind, Placebo-Controlled Trial for the Efficacy and Safety of a Novel Nutraceutical for Mild-to-Moderate Acne. J Cosmet Dermatol. 2025 May;24(5):e70220. doi: 10.1111/jocd.70220.
PubMed 40321085
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blinded, Randomized Control Evaluation of the Efficacy of an Oral Acne Supplement for Adult Women
- ClinicalTrials.gov ID
- NCT06097871
- Acronym / sponsor ID
- NW-CS-03
- Conditions
- Acne
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Nutraceutical Wellness Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 24 Jul 2024 (actual)
- Study completion
- 25 Jul 2024 (actual)
- First posted
- 24 Oct 2023 (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.
This study is to assess the efficacy and tolerability of an oral supplement in mild to moderate acne in adult females.
Detailed description
This is a 12-week, single-center, placebo controlled double blind, randomized clinical trial in adult female subjects with mild to moderate non-cystic acne. Female subjects will be enrolled in this single site study to evaluate the efficacy of an oral acne supplement. Upon enrollment, subjects will be randomized to a treatment or a placebo group. Both the subject and the investigator will be blinded to the subject's group allocation. The objective of this research is to assess the efficacy and tolerability of an oral supplement in mild to moderate non-cystic acne in adult females when compared to a placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 1-1 randomization to placebo or active treatment
| Arm | Type | Receives |
|---|---|---|
| Nutraceutical Dietary Supplement | Experimental | Dietary Supplement: Skin Nutraceutical SupplementA novel nutraceutical skin supplement, scientifically formulated to specifically target the multiple underlying causes of acne in women. The supplement is comprised of primary and secondary ingredients, designed to improve skin from the inside out. |
| Placebo | Placebo comparator | Other: Placebo pillOral supplement containing non-active ingredients. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Females subjects 18-50 years of age.
- Subjects with mild to moderate (non-cystic) acne (8 inflammatory lesions, 10 non-inflammatory lesions).
- Subjects with an IGA score of 2-3
- Subjects with all skin types (normal, oily, etc.)
- Subjects with all Fitzpatrick skin types I-VI.
Key exclusion criteria (27 listed)
- Any dermatological disorder, which in the investigator's opinion, may interfere with the accurate evaluation of the subject's skin characteristics, except for the study condition of acne.
- Subjects who are not willing to use the assigned skin care study products to their face as instructed and are not willing to take an oral acne supplement.
- Females who are pregnant, lactating, or planning to become pregnant during the study or within 30 days of study completion. (Subject must document her response in either the source documentation or informed consent/assent forms).
- Subject has a surgery and/or invasive medical procedure planned during the study.
- Subject has observable suntan, scars, nevi, tattoo, excessive hair (including beard, mustache, or goatee), or other dermal conditions on the face that could interfere with study evaluations or confound study results, as determined by the PI or designee.
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 |
|---|---|---|
| Skin Nutraceutical SupplementThe Skin Nutraceutical Supplement is made with Nutrafol's patented Synergen Skin Complex®, which is a blend of proprietary formulation of botanicals with potent anti-inflammatory, anti-stress adaptogenic, antioxidant and DHT-inhibiting properties combined to synergistically combat the multiple underlying factors that compromise skin health. These ingredients include Holy Basil, Maca, Curcumin, and Berberine in combination with other nutrients used to support skin health such as olive extract (20% hydroxytyrosol), konjac root (3% ceramides), vitamin A, B vitamins, and vitamin C. | Dietary supplement | Nutraceutical Dietary Supplement |
| Placebo pillA placebo pill containing non-active ingredients | Other | Placebo |
Primary outcome
Change in IGA at 12 weeks
Time frame: 12 weeks
The primary efficacy endpoint is the investigator assessed change from baseline to week 12 in facial acne IGA rating compared to placebo.
12 secondary outcomes
Change in IGA at 4 weeks
Time frame: 4 weeks
Change in IGA a 8 weeks
Time frame: 8 weeks
Change in corneometry measurements at 4 weeks
Time frame: 4 weeks
Change in sebumeter measurements at 4 weeks
Time frame: 4 weeks
Change in corneometry measurements at 8 weeks
Time frame: 8 weeks
Change in sebumeter measurements at 8 weeks
Time frame: 8 weeks
Change in corneometry measurements at 12 week
Time frame: 12 weeks
Change in sebumeter measurements at 12 week
Time frame: 12 weeks
Subject assessed improvement at week 4
Time frame: 4 weeks
Subject assessed improvement at week 8
Time frame: 8 weeks
Subject assessed improvement at week 12
Time frame: 12 weeks
Product-Related Safety outcomes
Time frame: All visits until 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- Derived from this study: PubMed 40321085Draelos Z, Harper J, Farris PK, Hazan A, Raymond I. A 12-Week Randomized, Double-Blind, Placebo-Controlled Trial for the Efficacy and Safety of a Novel Nutraceutical for Mild-to-Moderate Acne. J Cosmet Dermatol. 2025 May;24(5):e70220. doi: 10.1111/jocd.70220.
- Individual participant dataSharing planned: No
Related trials for Acne
Not yet recruitingPhase 3
Evaluation of the Efficacy and Safety of Fractional CO₂ Laser With and Without Intradermal Botulinum Toxin A in the Treatment of Inflammatory Facial Acne Vulgaris.
Acne, Acne Papulopustulosa
RecruitingPhase 4
Safety, Tolerability, and Clinical Effectiveness of Adapalene/Clindamycin Phosphate Gel (Klenzit®-C) in Vietnamese Patients With Mild to Moderate Acne Vulgaris
Acne
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
RecruitingPhase 4
Comparing Nadifloxacin Plus Tretinoin Versus Clindamycin Plus Tretinoin Creams for Mild-to-Moderate Acne
Acne Vulgaris
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skin Nutraceutical Supplement in people with Acne, run by Nutraceutical Wellness Inc. 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 15 inclusion and 27 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: finished, as of the sponsor's last update on 25 Sep 2024. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in IGA at 12 weeks (time frame: 12 weeks). 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 NCT06097871, which also lists 1 linked publication.
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 25 Sep 2024.