Clinical trial · Observational
The Application of Non-invasive and Cellular Level Resolution Fullfield Optical Coherence Tomography: Establishment and Analysis of Subcutaneous Cellular Level Image Database of Anatomical Locations in Healthy Volunteers and Evaluation of Usability
NCT04406454CI-TRIAL-00071335completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
ApolloVue® S100 Image System is a medical device class II. The objective of this protocol is to image skin of healthy volunteers and to evaluate the performance of full-field optical coherence tomography (FF-OCT) device - the ApolloVue® S100 Image System in imaging skin microstructures of healthy skin at different anatomical locations and nevi for different skin types and different age and to evaluate usability of the ApolloVue® S100 Image System.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Healthy Skin | — | UNRESOLVED | — |
| Nevus | Nevus | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ApolloVue® S100 Image System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Heathy volunteers
- description
- Patients has healthy skin at 5 anatomical locations including face, back, dorsal forearm, volar forearm, calf and at least a nevus without superficial scales and crusting.
- interventionNames
- Device: ApolloVue® S100 Image System
Primary outcomes (3)
- measure
- Determine the average scanning success rate of obtaining at least 3 quality OCT images of B-scan and E-scan with 4 depths for each skin site, respectively.
- timeFrame
- 2 years
- description
- * Scanning efficiency = total number of quality images/total number of images obtained x 100%. * Scanning efficiency ≧ 50%
- measure
- Evaluator identification of each feature will be assessed (number of correctly identified feature/number of total features x 100%).
- timeFrame
- 2 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: 1. All age will be recruited. 2. Both genders will be recruited. 3. All skin types will be recruited. Skin type I-VI (Fitzpatrick scale) * Type I always burns, never tans (unexposed skin color: white) * Type II usually burns, tans less than average (with difficulty) (unexposed skin color: white) * Type III sometimes mild burns, tans about average (unexposed skin color: white) * Type IV rarely burns, tans more than average (with easy) (unexposed skin color: white) * Type V very rarely burns (unexposed skin color: brown) * Type VI never burns (unexposed skin color: black) 4. Has healthy skin at 5 anatomical locations including face, back, dorsal forearm, volar forearm, and calf. 5. Has at least a nevus without superficial scales and crusting 6. Willing to provide informed consent Exclusion Criteria: 1. Individuals who have a systemic skin disorder. 2. Individuals who have a history of severe skin condition 3. Individuals with surgeries/cosmetic surgeries/micro cosmetic surgery (eg. cosmetic injections and/or laser etc.) on healthy skin at the 5 anatomical locations and nevi (see inclusion criteria 5) in last 12 months and a physician determine the surgery will affect outcome of the OCT images. 4. Not willing to cooperate with methods and related procedures of this trial/study
References
Publications (2)
- BACKGROUNDFitzpatrick TB. The validity and practicality of sun-reactive skin types I through VI. Arch Dermatol. 1988 Jun;124(6):869-71. doi: 10.1001/archderm.124.6.869. No abstract available. PMID 3377516
- BACKGROUNDAdabi S, Hosseinzadeh M, Noei S, Conforto S, Daveluy S, Clayton A, Mehregan D, Nasiriavanaki M. Universal in vivo Textural Model for Human Skin based on Optical Coherence Tomograms. Sci Rep. 2017 Dec 20;7(1):17912. doi: 10.1038/s41598-017-17398-8. PMID 29263332