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Observational Assessment of Skin Appearance Changes During PRX S Cosmetic Treatment in Participants With Acne-Prone Skin

Sponsor: WiQo S.p.A. • ClinicalTrials.gov ID: NCT07866131

Registry updated: 2026-10-08

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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

PRX S topical cosmetic treatment (Other)
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.

Eligibility criteria

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.

Conditions

Acne-prone Skin Skin Disease

Locations

Regain Functional Medicine and Aesthetics — Leawood, Kansas, United States
VibrantSkin Dermatology and Laser — Tulsa, Oklahoma, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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