Observational Assessment of Skin Appearance Changes During PRX S Cosmetic Treatment in Participants With Acne-Prone Skin
Part of paid clinical trials in Leawood, Kansas.
- Sponsor
- WiQo S.p.A.
- Study ID
- NCT07866131
- Status
- Recruiting
Conditions
- Acne-prone Skin
- Skin Disease
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- PRX S topical cosmetic treatment — OTHERPRX 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) — OTHERA 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 Details
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.
Key Dates
- First listed
- Oct 8, 2026
- Start date
- Sep 21, 2026
- Status verified
- Sep 2026
- Primary completion
- Dec 31, 2026
- Completion
- Dec 31, 2026
Study Design
- Enrollment
- 30 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: PRX S Cosmetic Treatment with Home Care Regimen
Primary Outcome Measure
Change in VISIA Pores Score [ Time Frame: Baseline (T0, Week 0), mid-cycle (T1, Week 6), end of follow-up (T2, Week 10) ]
Central Contacts
- Deborah Subissati+39 040360408
- Maria Luisa Garo+393774326165
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Regain Functional Medicine and Aesthetics | Leawood | Kansas | 66211 | Kathy Gaumer (PRINCIPAL_INVESTIGATOR) |
| VibrantSkin Dermatology and Laser | Tulsa | Oklahoma | 74137 | Kesha Buster, MD (PRINCIPAL_INVESTIGATOR) |