Observational Assessment of Skin Appearance Changes During PRX S Cosmetic Treatment in Participants With Acne-Prone Skin
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWiQo S.p.A.
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
PRX S topical cosmetic treatment
Other interventionPRX 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 interventionA 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: PRX S Cosmetic Treatment with Home Care RegimenExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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)2
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)3
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)4
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)Secondary outcomes
1
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)2
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)3
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)4
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)Other outcomes
1
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)2
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
WiQo S.p.A.
Lead sponsor
Mathsly Research
Collaborator
Source ClinicalTrials.gov