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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