MelanosisPhase 2KligmanNCT05119413
Comparison of a New Masterful Preparation to Kligman's Trio in the Treatment of Melasma
A Phase 2 study testing New trio de Kligman and Trio Kligman in people with Melanosis, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanosis
- What is being tested?
- New trio de Kligman and Trio Kligman
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 30 Nov 2021to 15 Dec 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- SIGNED WRITTEN CONSENT 1) Melasma clinically diagnosed
Who cannot join
- Pregnant woman
- Other pigmentary disorder affecting the face
- Use of systemic or topical steroids or retinoids, use of topical depigmenting agents or depigmenting procedure in the month before the inclusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of a New Masterful Preparation to Kligman's Trio in the Treatment of Melasma: a Double Blind Prospective Randomzed Study
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.
- Conditions
- Melanosis
- Being tested
- New trio de Kligman, Trio Kligman
- Medical subject headings
- Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New trio de KligmanDrug
Once daily application in addition to the same sunscreen
Trio KligmanDrug
Once daily application in addition to the same sunscreen
| Study group | Role | What they receive |
|---|---|---|
| New traitement | Experimental | Thiamidol, retinoid, topical steroid preparation Receives: Drug: New trio de Kligman |
| Kligman's trio | Other | Application once a day for 12 weeks Receives: Drug: Trio Kligman |
What is being measured
The primary outcome is the main question the study is designed to answer.
The melasma's type
Clinical score MASI
Measured: at 12 weeks
Secondary outcomes (1)
the Quality of life of patient
descriptive name of scale : meslascol
Measured: at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2021
- Study start30 Nov 2021
- Primary completion16 Sep 2022
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MelanosisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thierry Passeron, PhD, Principal investigator, CHU de Nice, Service de Dermatologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05119413
- Sponsor's protocol ID
- 20-PP-30
- Acronym
- Kligman
- Status last verified
- Mar 2026
- First submitted
- 4 Oct 2021
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bertold C, Fontas E, Singh T, Gastaut N, Ruitort S, Wehrlen Pugliese S, Passeron T. Efficacy and safety of a novel triple combination cream compared to Kligman's trio for melasma: A 24-week double-blind prospective randomized controlled trial. J Eur Acad Dermatol Venereol. 2023 Dec;37(12):2601-2607. doi: 10.1111/jdv.19455. Epub 2023 Sep 4.
PubMed 37620285
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of a New Masterful Preparation to Kligman's Trio in the Treatment of Melasma: a Double Blind Prospective Randomzed Study
- ClinicalTrials.gov ID
- NCT05119413
- Acronym / sponsor ID
- Kligman / 20-PP-30
- Conditions
- Melanosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 30 Nov 2021 (actual)
- Primary completion
- 16 Sep 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 15 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| New traitement | Experimental | Drug: New trio de KligmanThiamidol, retinoid, topical steroid preparation |
| Kligman's trio | Other | Drug: Trio KligmanApplication once a day for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- SIGNED WRITTEN CONSENT 1) Melasma clinically diagnosed
Key exclusion criteria (3 listed)
- Pregnant woman
- Other pigmentary disorder affecting the face
- Use of systemic or topical steroids or retinoids, use of topical depigmenting agents or depigmenting procedure in the month before the inclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| New trio de KligmanOnce daily application in addition to the same sunscreen | Drug | New traitement |
| Trio KligmanOnce daily application in addition to the same sunscreen | Drug | Kligman's trio |
Primary outcome
The melasma's type
Time frame: at 12 weeks
Clinical score MASI
1 secondary outcome
the Quality of life of patient
Time frame: at 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Results publication: PubMed 37620285Bertold C, Fontas E, Singh T, Gastaut N, Ruitort S, Wehrlen Pugliese S, Passeron T. Efficacy and safety of a novel triple combination cream compared to Kligman's trio for melasma: A 24-week double-blind prospective randomized controlled trial. J Eur Acad Dermatol Venereol. 2023 Dec;37(12):2601-2607. doi: 10.1111/jdv.19455. Epub 2023 Sep 4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thierry Passeron, PhD principal investigator
CHU de Nice, Service de Dermatologie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing New trio de Kligman and Trio Kligman in people with Melanosis, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The melasma's type (time frame: at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05119413, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.