Clinical TrialID 7466
Randomized and Open Label Study for Safety and Efficacy of DBI-102 vs. Vehicle vs. Hydroquinone on Skin Pigmentation and Lentigos
NCT05511948
Hyperpigmentation
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 7466
- Evidence Id
- 7466
- Core Evidence Id
- 7466
- Source Clinical Trial Id
- 7462
- Herb2 Clinical Trial Id
- HBCT007462
- Nct Id
- NCT05511948
- Title
- Randomized and Open Label Study for Safety and Efficacy of DBI-102 vs. Vehicle vs. Hydroquinone on Skin Pigmentation and Lentigos
- Status
- Completed
- Phase
- Phase 2
- Study Result
- No
- Study Condition
- Hyperpigmentation
- Study Type
- Interventional
- Study Design
- Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
- Intervention
- DRUG: DBI-102|DRUG: Vehicle gel|DRUG: Hydroquinone Cream
- Intervention Allocation
- Randomized
- Intervention Model
- Sequential
- Intervention Mask
- Triple
- Intervention Purpose
- Treatment
- Gender
- All
- Age
- Adult, Older_Adult
- Enrollment
- 75
- Outcome Measure
- Decrease in pigmentation based on melanin index, Change in L\* and ITA colorimetry measurements, 12 weeks after first dose|Decrease in pigmentation based on digital imaging, Change as measured with Canfield RBX software analysis, 12 weeks after first dose
- Sponsor Collaborator
- DermBiont, Inc.
- Funded By
- INDUSTRY
- Location
- Zepeda Dermatologia, Santa Tecla, La Libertad, CP1501, El Salvador
- Other Id
- CT-212
- Start Date
- 2022-08-18
- Primary Completion Date
- 2023-03-07
- Completion Date
- 2023-03-07
- First Posted
- 2022-08-23
- Results First Posted
- Last Update Posted
- 2023-10-25
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT05511948
- Title Cn
- Title En
- Randomized and Open Label Study for Safety and Efficacy of DBI-102 vs. Vehicle vs. Hydroquinone on Skin Pigmentation and Lentigos
- Bilingual Status
- semi_complete