Revitalis - Midface (Cheek Area)
NCT07931482, Not applicable, Recruiting, Croma-Pharma GmbH
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Revitalis - Midface (Cheek Area) | ClinicalTrials.gov |
| NCT number | NCT07931482 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 80 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Croma-Pharma GmbH | ClinicalTrials.gov |
| Conditions | Skin Smoothness | ClinicalTrials.gov |
| Interventions | Croma revitalis | ClinicalTrials.gov |
| First posted | 2026-11-12 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Skin Smoothness: Responder status assessed by independent evaluator at site | week 12 | Responder status as assessed by a live independent evaluator at site using the validated Canfield Skin Quality Scale - Skin Smoothness (CSQS-SS) | ClinicalTrials.gov |
| Secondary | Skin Smoothness: Responder status assessed by independent evaluator at site - other timepoints | week 9, week 16, week 20, week 24, week 30 | To evaluate improvement in midface (cheek area) skin smoothness using the validated CSQS-SS at additional study timepoints, as assessed by a live independent evaluator at site | ClinicalTrials.gov |
| Secondary | Skin Smoothness: Responder status assessed by blinded panel | week 9, week 12, week 16, week 20, week 24, week 30 | To evaluate improvement in midface (cheek area) skin smoothness using the validated CSQS-SS at additional study timepoints, as assessed by a blinded panel of three independent evaluators via photographic review. | ClinicalTrials.gov |
| Secondary | Skin Smoothness: Change from Baseline assessed by independent evaluator at site | Week 9, 12, 16, 20, 24 and 30 | Change from baseline in CSQS-SS scores based on assessment of both sides by a live independent evaluator at site | ClinicalTrials.gov |
| Secondary | Skin Smoothness: Change from baseline assessed by blinded panel | Week 9, 12, 16, 20, 24 and 30 | Change from baseline in CSQS-SS scores based on the blinded panel of three independent evaluators via photographic review assessment | ClinicalTrials.gov |
| Secondary | Cheek Lines: Responder Status assessed by independent evaluator at site | Week 9, 12, 16, 20, 24, and 30 | Responder status at follow-up time points based on CSQS-CL assessment by a live independent evaluator at site | ClinicalTrials.gov |
| Secondary | Cheek Lines: Change from Baseline assessed by independent evaluator at site | Week 9, 12, 16, 20, 24 and 30 | Change from baseline in CSQS-CL scores based on assessment of both sides by a live independent evaluator at site. | ClinicalTrials.gov |
| Secondary | Cheek Lines: Responder status assessed by blinded panel | Week 9, 12, 16, 20, 24, and 30 | Responder status at follow-up time points based on blinded panel of three independent evaluators via photographic review assessment using CSQS-CL. | ClinicalTrials.gov |
| Secondary | Cheek Lines: Change from Baseline assessed by blinded panel | Week 9, 12, 16, 20, 24 and 30 | Change from baseline in CSQS-CL scores, based on the blinded panel of three independent evaluators via photographic review assessment | ClinicalTrials.gov |
| Secondary | FACE-Q™ Satisfaction with Skin | Week 9, 12, 16, 20, 24 and 30 | Participant-reported outcomes using FACE-Q™ Satisfaction with Skin | ClinicalTrials.gov |
| Secondary | FACE-Q™ Satisfaction with Outcome | Week 9, 12, 16, 20, 24 and 30 | Participant-reported outcomes using FACE-Q™ Satisfaction with Outcome | ClinicalTrials.gov |
| Secondary | FACE-Q™Lines Appraisal | Week 9, 12, 16, 20, 24 and 30 | Participant-reported outcomes using FACE-Q™ Lines Appraisal | ClinicalTrials.gov |
| Secondary | GAIS assessed by the participants | Week 9, 12, 16, 20, 24, and 30 | Global Aesthetic Improvement Scale (GAIS) assessed by the participants | ClinicalTrials.gov |
| Secondary | GAIS assessed by an independent evaluator at site | Week 9, 12, 16, 20, 24, and 30 | Global Aesthetic Improvement Scale (GAIS) assessed by and independent evaluator at site | ClinicalTrials.gov |
| Secondary | Skin hydration: change from baseline | Week 9, 12, 16, 20, 24, and 30 | Change from baseline in midface (cheek area) skin hydration as measured by corneometer | ClinicalTrials.gov |
| Secondary | Skin elasticity: change from baseline | Week 9, 12, 16, 20, 24, and 30 | Change from baseline in midface (cheek area) skin elasticity as measured by cutometer | ClinicalTrials.gov |
| Secondary | Skin firmness(tone): change from baseline | Week 9, 12, 16, 20, 24, and 30 | Change from baseline in midface (cheek area) skin firmness(tone) as measured by cutometer | ClinicalTrials.gov |
| Other | Safety Events occurence | From first treatment, up to 30 weeks after first treatment ( until study completion or withdrawal) | Occurrence, severity, and relationship to treatment of AEs, SAEs, and ADEs throughout the study | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)