Clinical trial • Dermatology
Hydroquinone; Tretinoin for Melasma | Facial melasma
Clinical trial of Hydroquinone; Tretinoin for Melasma | Facial melasma.
Overview
- Trial Therapeutic Area
- Dermatology
- Trial Disease
- Melasma | Facial melasma
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 16-01-2026
- First CTIS Authorization Date
- 05-05-2026
Trial design
Randomised, topical formulation with 4% hydroquinone and 0.025% tretinoin versus topical formulation with 4% hydroquinone-controlled trial across 1 site in Spain.
- Randomised
- Yes
- Comparator
- Topical formulation with 4% hydroquinone and 0.025% tretinoin versus topical formulation with 4% hydroquinone
- Target Sample Size
- 21
Eligibility
Recruits 21 No vulnerable populations selected (isVulnerablePopulationSelected=false)..
- Vulnerable Population
- No vulnerable populations selected (isVulnerablePopulationSelected=false).
Recruitment
- Planned Sample Size
- 21
- Recruitment Window Months
- 10
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 21
Spain
- Earliest CTIS Part Ii Submission Date
- 21-04-2026
- Latest Decision Or Authorization Date
- 05-05-2026
- Processing Time Days
- 14
- Number Of Sites
- 1
- Number Of Participants
- 21
Sites
- Site Name
- Hospital Universitario Hm Torrelodones
- Department Name
- Oftalmologia
- Principal Investigator Name
- Maria del Mar Martin Dorado
- Principal Investigator Email
- mardorado9@gmail.com
- Contact Person Name
- Maria del Mar Martin Dorado
- Contact Person Email
- mardorado9@gmail.com
- Number Of Participants
- 21
Sponsor
Primary sponsor
- Full Name
- Mesoestetic Pharma Group S.L.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Spain
Investigational products
- Investigational Product Name
- Topical formulation with 4% hydroquinone and 0.025% tretinoin
- Active Substance
- Hydroquinone; Tretinoin
- Modality
- Small molecule
- Routes Of Administration
- Topical (cutaneous)
- Route
- Topical
- Starting Dose
- 4% hydroquinone and 0.025% tretinoin (concentration)
- Investigational Product Name
- Topical formulation with 4% hydroquinone
- Active Substance
- Hydroquinone
- Modality
- Small molecule
- Routes Of Administration
- Topical (cutaneous)
- Route
- Topical
- Starting Dose
- 4% hydroquinone (concentration)
- Combination Treatment
- Yes
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