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Comparison of a New Masterful Preparation to Kligman's Trio in the Treatment of Melasma

Comparison of a New Masterful Preparation to Kligman's Trio in the Treatment of Melasma: a Double Blind Prospective Randomzed Study

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05119413
Acronym
Kligman
Enrollment
40
Registered
2021-11-15
Start date
2021-11-30
Completion date
2022-12-15
Last updated
2026-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanosis

Brief summary

Kligman's trio remains the gold standard treatment for melasma. It contain hydroquinone which is an effective anti-melanogenic compound but that has poor tolerance and numerous side-effects. Thiamidol has been proven to be at least as effective as hydroquinone and has a very good safety profile. The objective of this study is to compare the Kligman's trio to the same preparation in which hydroquinone is replaced by thiamidol.

Interventions

DRUGNew trio de Kligman

Once daily application in addition to the same sunscreen

DRUGTrio Kligman

Once daily application in addition to the same sunscreen

Sponsors

Centre Hospitalier Universitaire de Nice
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* SIGNED WRITTEN CONSENT 1) Melasma clinically diagnosed

Exclusion criteria

1. Pregnant woman 2. Other pigmentary disorder affecting the face 3. Use of systemic or topical steroids or retinoids, use of topical depigmenting agents or depigmenting procedure in the month before the inclusion

Design outcomes

Primary

MeasureTime frameDescription
The melasma's typeat 12 weeksClinical score MASI

Secondary

MeasureTime frameDescription
the Quality of life of patientat 12 weeksdescriptive name of scale : meslascol

Countries

France

Contacts

PRINCIPAL_INVESTIGATORThierry Passeron, PhD

CHU de Nice, Service de Dermatologie

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026