Observational look at how PRX S cosmetic treatment changes skin appearance in adults with acne-prone skin

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot cohort study evaluates changes in skin surface appearance during and after a standardized five-session cycle of PRX S topical cosmetic treatment for oily and acne-prone skin. Participants will receive five in-office treatments at two-week intervals and follow a prescribed home care regimen, with assessments at baseline, mid-cycle, and week 10. Objective skin parameters, clinician-rated acne severity, and patient-reported quality of life will be measured using VISIA analysis, IGA/GAGS scores, and QoL surveys in a non-randomized, pre-post design across two U.S. sites. The study aims to identify associations between the treatment cycle and changes in pore appearance, texture, spots, redness, and porphyrins, without a designated primary endpoint. Data will be collected to explore potential cosmetic benefits and safety in adults with acne-prone skin.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Principal investigator: Kathy Gaumer, MD — Regain Functional Medicine and Aesthetics, Leawood, KS
• Study coordinator: Deborah Subissati
• Email: deborah.subissati@wiqo.eu
• Phone: +39 040360408

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.