An interventional study of PRX S topical cosmetic treatment and WiQo home care regimen (Nourishing Cream; Balancing Cream) in Acne-prone Skin and Skin Disease, sponsored by WiQo S.p.A.. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by WiQo S.p.A. · Not applicable, Interventional, and Treatment
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.
538 studies on the registry are indexed under Skin Diseases; 92 are open to participants now.
This study's planned enrollment of 30 is below the median of 60 across 372 interventional studies indexed under Skin Diseases.
Browse Skin Diseases studies →This is the only study on the registry with WiQo S.p.A. as lead sponsor.
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Exclusion Criteria:
Other: PRX S topical cosmetic treatment · Other: WiQo home care regimen (Nourishing Cream; Balancing Cream)
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (T0, Week 0), mid-cycle (T1, Week 6), end of follow-up (T2, Week 10)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Through study completion (Week 10)
VISIA Acne-Prone Skin Composite Index (VISIA-APS)
Pre-specified composite summary index computed as the mean of the z-scores of the five principal VISIA parameters (pores, spots, red areas, porphyrins, and texture), standardized using the sample mean and SD at baseline (T0). The direction of each z-score is pre-specified so that positive values consistently indicate improvement. The VISIA-APS has no fixed minimum or maximum; higher values indicate greater overall improvement across all five acne-prone skin parameters and represent a better outcome.
Time frame: Baseline (T0, Week 0), mid-cycle (T1, Week 6), end of follow-up (T2, Week 10)
VISIA Wrinkles Score
Objective wrinkle 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 wrinkles relative to the reference population. This parameter is reported descriptively only and is not included in formal inferential analyses.
Time frame: Baseline (T0, Week 0), mid-cycle (T1, Week 6), end of follow-up (T2, Week 10)
Plan to share: 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.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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