Acne-prone SkinNCT07866131
Observational Assessment of Skin Appearance Changes During PRX S Cosmetic Treatment in Participants With Acne-Prone Skin
A study testing PRX S topical cosmetic treatment and WiQo home care regimen (Nourishing Cream; Balancing Cream) in people with Acne-prone Skin and Skin Disease, run by WiQo S.p.A. at 2 sites in United States.
Trial summary
This pilot cohort study evaluates changes in skin surface appearance in adult participants with acne-prone skin during and following a standardized five-session course of PRX S (WiQo SpA), a topical cosmetic product designed for oily and acne-prone skin. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acne-prone Skin, Skin Disease
- What is being tested?
- PRX S topical cosmetic treatment and WiQo home care regimen (Nourishing Cream; Balancing Cream)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Sep 2026to Dec 2026
- Phase
- Interventional
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years or older at the time of informed consent.
- Presence of acne-prone skin characteristics defined as an IGA score of 1 (almost clear) to 3 (moderate) at baseline (T0).
- Willing and able to commit to 5 in-office treatment sessions at approximately 2-week intervals over approximately 8 weeks, plus one follow-up visit at Week 10.
- Willing to discontinue all current skincare products and adhere exclusively to the WiQo standardized home care regimen throughout the study period. The participant's current skincare regimen must be, in the investigator's judgment, safe to discontinue on the day of the first treatment session without requiring a prior washout period.
- Able to understand and willing to sign the informed consent form prior to any study procedure.
- In general good health as determined by medical history and investigator judgment.
- Ability to read and understand English at a level sufficient to provide written informed consent and complete all study questionnaires independently.
Who cannot join
- IGA score of 0 (clear) or 4 (severe) at baseline.
- Active skin infection, open wounds, or acute inflammatory dermatological conditions in the facial treatment area at the time of enrollment.
- History of hypersensitivity or known allergy to any component of the PRX S formulation or the WiQo home care products.
- Use of systemic retinoids within 6 months prior to enrollment.
- Use of systemic antibiotics for acne within 4 weeks prior to enrollment.
- Ongoing use of topical prescription acne medications (retinoids, topical antibiotics, dapsone) that the participant is unwilling or unable to discontinue.
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- Pregnancy, breastfeeding, or planned pregnancy during the study period. Pregnancy status is determined by participant self-report at screening and confirmed through the signed Informed Consent Form, in which the participant acknowledges that pregnancy constitutes a contraindication to the study treatment.
- Prior cosmetic or aesthetic treatment of the face (chemical peel, laser, microneedling, injectables) within 4 weeks prior to enrollment, or prior treatment of the chest or back within 4 weeks prior to enrollment that, in the investigator's judgment, could confound GAGS assessments.
- Any active medical condition that, in the investigator's judgment, could confound study assessments or place the participant at undue risk.
- Participation in another interventional clinical study within 30 days prior to enrollment.
- Inability or unwillingness to comply with study procedures and follow-up requirements.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Regain Functional Medicine and Aesthetics
Leawood, Kansas, 66211
Kathy Gaumer, MD, 913-291-8555, kathy.gaumer@gmail.com
Kathy Gaumer
- Recruiting
VibrantSkin Dermatology and Laser
Tulsa, Oklahoma, 74137
Kesha Buster, MD, 918-340-6539, drbuster@vibrantskintulsa.com
Kesha Buster, MD
About this study
Official title: Observational Assessment of Skin Appearance Changes During PRX S Cosmetic Treatment in Participants With Acne-Prone Skin: A Multicenter Pilot Cohort Pre-Post Study
This pilot cohort study evaluates changes in skin surface appearance in adult participants with acne-prone skin during and following a standardized five-session course of PRX S (WiQo SpA), a topical cosmetic product designed for oily and acne-prone skin.
The study asks whether a standardized in-office PRX S treatment cycle - five sessions administered at two-week intervals and complemented by a prescribed home care regimen - is associated with observable changes in objective skin surface parameters (pore appearance, texture, spots, redness, porphyrins), clinician-rated acne severity (IGA, GAGS), and participant-reported skin-related quality of life (QoL-RA) in adults with acne-prone skin.
Using a single-group, pre-post observational design across two U.S. sites (Leawood, KS and Tulsa, OK), 30 participants will undergo VISIA complexion analysis and clinical assessments at baseline (T0), mid-cycle (T1, Week 6), and end of follow-up (T2, Week 10). No single primary endpoint is designated; all analyses are explicitly exploratory.
- Conditions
- Acne-prone Skin, Skin Disease
- Being tested
- PRX S topical cosmetic treatment, WiQo home care regimen (Nourishing Cream; Balancing Cream)
- Keywords
- acne-prone skin, skin condition, cosmetics, pore refinement, quantitative evaluation, quality of life
- Medical subject headings
- Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRX S topical cosmetic treatmentOther
PRX S (WiQo SpA, Milan, Italy) is a topical cosmetic formulation designed for acne-prone and oily skin. It is applied in-office by trained aesthetic professionals or dermatologists using a proprietary non-ablative technique with no visible peeling or downtime. Five sessions are administered at two-week intervals (Weeks 0, 2, 4, 6, 8). The application procedure is adapted to the participant's skin presentation: Procedure 1 for oily skin with enlarged pores; Procedure 2 for comedone-predominant presentations. PRX S is supplied directly to study sites by the Sponsor free of charge.
WiQo home care regimen (Nourishing Cream; Balancing Cream)Other
A standardized daily home care regimen prescribed in conjunction with in-office PRX S sessions, consisting of two commercially available cosmetic products supplied by the Sponsor: WiQo Nourishing Cream for Normal and Combination Skin (applied each morning) and WiQo Balancing Cream (applied each evening). The Balancing Cream contains micronized azelaic acid, encapsulated salicylic acid, fermented botanical extracts, and niacinamide. Both products are supplied to participants free of charge for the duration of the study.
| Study group | Role | What they receive |
|---|---|---|
| PRX S Cosmetic Treatment with Home Care Regimen | Experimental | Not described Receives: Other: PRX S topical cosmetic treatment; Other: WiQo home care regimen (Nourishing Cream; Balancing Cream) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in VISIA Pores Score
Objective pore assessment performed by VISIA Complexion Analysis system (Canfield Scientific, Parsippany, NJ). The score is a normalized index relative to an age- and phototype-matched reference population. Lower scores indicate fewer visible pores relative to the reference population and represent a better outcome.
Measured: Baseline (T0, Week 0), mid-cycle (T1, Week 6), end of follow-up (T2, Week 10)
Change in VISIA Spots Score
Objective spot assessment performed by VISIA Complexion Analysis system (Canfield Scientific, Parsippany, NJ). The score is a normalized index relative to an age- and phototype-matched reference population. Lower scores indicate fewer visible spots relative to the reference population and represent a better outcome.
Measured: Baseline (T0, Week 0), mid-cycle (T1, Week 6), end of follow-up (T2, Week 10)
Change in VISIA Red Areas Score
Objective assessment of red area extent performed by VISIA Complexion Analysis system (Canfield Scientific, Parsippany, NJ) using RBX® Red channel imaging. The score is a normalized index relative to an age- and phototype-matched reference population. Lower scores indicate reduced surface redness relative to the reference population and represent a better outcome.
Measured: Baseline (T0, Week 0), mid-cycle (T1, Week 6), end of follow-up (T2, Week 10)
Change in VISIA Porphyrins Score
Objective porphyrin assessment performed by VISIA Complexion Analysis system (Canfield Scientific, Parsippany, NJ) using UV fluorescence photography. The score is a normalized index relative to an age- and phototype-matched reference population. Lower scores indicate fewer porphyrins relative to the reference population and represent a better outcome.
Measured: Baseline (T0, Week 0), mid-cycle (T1, Week 6), end of follow-up (T2, Week 10)
Change in VISIA Texture Score
Objective skin texture assessment performed by VISIA Complexion Analysis system (Canfield Scientific, Parsippany, NJ). The score is a normalized index relative to an age- and phototype-matched reference population. Lower scores indicate smoother skin texture relative to the reference population and represent a better outcome.
Measured: Baseline (T0, Week 0), mid-cycle (T1, Week 6), end of follow-up (T2, Week 10)
Secondary outcomes (4)
Change in Investigator Global Assessment (IGA) Score
Clinician-rated acne severity assessed using the Investigator Global Assessment (IGA) scale, a 5-point ordinal scale ranging from 0 to 4 (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe). Lower scores indicate less severe acne and represent a better outcome. The T0 value serves as individual reference.
Measured: Baseline (T0, Week 0), mid-cycle (T1, Week 6), end of follow-up (T2, Week 10)
Change in Global Acne Grading System (GAGS) Score
Clinician-rated acne severity assessed using the Global Acne Grading System (GAGS), a weighted scoring instrument that evaluates acne lesion type and distribution across six facial and truncal regions (forehead, right cheek, left cheek, nose, chin, and chest/back). Total scores range from 0 to 44: 0 = no acne; 1-18 = mild; 19-30 = moderate; 31-38 = severe; >38 = very severe. Lower scores indicate less severe acne and represent a better outcome. The T0 value serves as individual reference.
Measured: Baseline (T0, Week 0), mid-cycle (T1, Week 6), end of follow-up (T2, Week 10)
Change in Quality of Life Relevance-Acne (QoL-RA) Score
Participant-reported acne-related quality of life assessed using the Quality of Life Relevance-Acne (QoL-RA) questionnaire (Chernyshov et al., JAAD International, 2024). The QoL-RA is a 19-item self-reported instrument covering 3 dimensions: Socioemotional (11 items), Symptoms (4 items), and Stigma and Suicidal thoughts (4 items). Each item is rated on a 4-point scale (0 = Never; 1 = Rarely; 2 = Sometimes; 3 = Frequently); total scores range from 0 to 57. Higher scores indicate greater HRQoL impairment and represent a worse outcome.
Measured: Baseline (T0, Week 0), mid-cycle (T1, Week 6), end of follow-up (T2, Week 10)
Treatment Tolerability
Incidence and type of adverse events and product-related tolerability findings across all 5 treatment sessions.
Measured: Through study completion (Week 10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study start21 Sep 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne-prone 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- WiQo S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mathsly Research
- Responsible party
- Sponsor
- Investigators
- Maria Luisa Garo, Study director, Mathsly ResearchKathy Gaumer, MD, Principal investigator, Regain Functional Medicine and Aesthetics, Leawood, KSKesha Buster, MD, Principal investigator, VibrantSkin Dermatology and Laser, Tulsa, OKDeborah Subissati, Study chair, WiQo S.p.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07866131
- Sponsor's protocol ID
- WIQO-PRXS-001
- Status last verified
- Sep 2026
- First submitted
- 30 Sep 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. All data collected in this study are proprietary to the Sponsor (WiQo SpA) and are subject to applicable data privacy and protection regulations, including the EU General Data Protection Regulation (GDPR) and applicable U.S. state privacy laws. No IPD sharing is planned.