NCT07866131 · WiQo S.p.A.
Observational Assessment of Skin Appearance Changes During PRX S Cosmetic Treatment in Participants With Acne-Prone Skin
What this study is about
This pilot group of participants 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.
View original scientific description
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.
Interventions
OTHER
PRX S topical cosmetic treatment
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.
OTHER
WiQo home care regimen (Nourishing Cream; Balancing Cream)
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.
Primary outcome measures
Change in VISIA Pores Score
Time frame: Baseline (T0, Week 0), mid-cycle (T1, Week 6), end of follow-up (T2, Week 10)
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.
Change in VISIA Spots Score
Time frame: Baseline (T0, Week 0), mid-cycle (T1, Week 6), end of follow-up (T2, Week 10)
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.
Change in VISIA Red Areas Score
Time frame: Baseline (T0, Week 0), mid-cycle (T1, Week 6), end of follow-up (T2, Week 10)
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.
Change in VISIA Porphyrins Score
Time frame: Baseline (T0, Week 0), mid-cycle (T1, Week 6), end of follow-up (T2, Week 10)
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.
Change in VISIA Texture Score
Time frame: Baseline (T0, Week 0), mid-cycle (T1, Week 6), end of follow-up (T2, Week 10)
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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.
- 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.
Where
- Leawood, Kansas
- Tulsa, Oklahoma
Collaborators
Mathsly Research
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 8, 2026 · Source of record for eligibility and locations