CTRI/2024/02/063322
Not Yet Recruiting
Phase 4
A Clinical Study to evaluate the Safety and Efficacy of ACELABS Lumiere Rebalancing Diamond Drop for advanced skin brightening. - NI
Bright Diva Pte. Ltd.0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Bright Diva Pte. Ltd.
- Status
- Not Yet Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Gender: Male or Female aged between 20 to 30, with minimum F:M distribution ratio of 2:1
- •2\.Subject willing to give written informed consent
- •3\.Women of child bearing potential must have a negative urine pregnancy test
- •4\.Free of any systemic and dermatologic disorder, which in the opinion of the investigator, will interface with the study results or increase the risk of AE.
- •5\.Are willing to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural or artificial) for the duration of the study.
Exclusion Criteria
- •1\.Subjects who are pregnant, breast feeding, or planning to become pregnant during the study
- •2\.Have any evidence of systematic cancer, squamous cell carcinoma, basal cell carcinoma in the last 5 years, or any other confounding skin condition.
- •3\.Have open sore or open lesions in the treatment area
- •4\.Have any condition that, in the opinion of the investigator, would confound the safety and efficacy assessments of the product.
- •5\.Have participated in any interventional clinical trial in the previous 30 days.
- •6\.Have a known sensitivity to any of the constituents of the test product including sensitivities to any of the constituents.
- •7\.Have used, are using, or are planning to use immunosuppressive or immunomodulatory medications (i.e., biologics), blood purifiers and including corticosteroids.
- •8\.Have a history of alcohol or illegal drug/ substance abuse or suspected alcohol or illegal drug/substance abuse in the past 2 years.
Outcomes
Primary Outcomes
Not specified
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