Recruiting

PRX S

Sponsor:

WiQo S.p.A.

Code:

NCT07866131

Conditions

Acne-prone Skin

Skin Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

PRX S topical cosmetic treatment

WiQo home care regimen (Nourishing Cream; Balancing Cream)

Study Details

Brief 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.

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

Study ID

NCT07866131

Start date

Sep 21, 2026

Status verified date

Sep, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: PRX S Cosmetic Treatment with Home Care Regimen

Interventions

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.

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 measure

  • Change in VISIA Pores Score [ Time Frame: Baseline (T0, Week 0), mid-cycle (T1, Week 6), end of follow-up (T2, Week 10) ]
  • Change in VISIA Spots Score [ Time Frame: Baseline (T0, Week 0), mid-cycle (T1, Week 6), end of follow-up (T2, Week 10) ]
  • Change in VISIA Red Areas Score [ Time Frame: Baseline (T0, Week 0), mid-cycle (T1, Week 6), end of follow-up (T2, Week 10) ]
  • Change in VISIA Porphyrins Score [ Time Frame: Baseline (T0, Week 0), mid-cycle (T1, Week 6), end of follow-up (T2, Week 10) ]
  • Change in VISIA Texture Score [ Time Frame: Baseline (T0, Week 0), mid-cycle (T1, Week 6), end of follow-up (T2, Week 10) ]

Central Contacts and Locations

Central contacts

Deborah Subissati

+39 040360408deborah.subissati@wiqo.eu

Maria Luisa Garo

+393774326165marilu.garo@mathsly.it

Locations

Regain Functional Medicine and Aesthetics

Recruiting

Leawood, Kansas, United States, 66211

Contacts

Kathy Gaumer, MD

913-291-8555kathy.gaumer@gmail.com

Principal Investigator:

Kathy Gaumer

VibrantSkin Dermatology and Laser

Recruiting

Tulsa, Oklahoma, United States, 74137

Contacts

Kesha Buster, MD

918-340-6539drbuster@vibrantskintulsa.com

Principal Investigator:

Kesha Buster, MD

More Information

Sponsor

WiQo S.p.A.

Last update posted

Oct 8, 2026

Last verified

Sep, 2026

Keywords

  • acne-prone skin
  • skin condition
  • cosmetics
  • pore refinement
  • quantitative evaluation
  • quality of life

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-09. This information was provided to ClinicalTrials.gov by WiQo S.p.A. on 2026-10-08. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.