MelanosisPhase 4NCT00863278
Treatment of Melasma With Stabilized Kligman Preparation Associated or Not With Pulsed Dye Laser
A Phase 4 study testing pulsed dye laser treatment and Kligman's Trio in people with Melanosis, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Melasma is an acquired disorder of pigmentation that leads to irregular pigmented patches on the face. Treatment is difficult and to date the best treatment option is the combination of hydroquinone, retinoic acid and steroids combined in topical daily application (called Kligman's trio). Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Melanosis
- What is being tested?
- pulsed dye laser treatment and Kligman's Trio
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2009to Dec 2010
- Phase
- Phase 4
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pregnant women or breastfeeding.
- Skin type 5 or 6.
Who cannot join
- Known allergy to the compounds of the Kligman preparation.
- Refusal to put very high protection sunscreen during the study.
- Concomitant use of topical products that might have an effect on melasma (topical steroids, retinoids, etc…)
Trial locations and contacts
1 site in 1 country.
France1 site
CHU de Nice - 4 avenue Reine Victoria - Hôpital de Cimiez
Nice, Alpes-Maritimes, 06001
About this study
Official title: Treatment of Melasma With Stabilized Kligman Preparation Associated or Not With Pulsed Dye Laser; a Comparative Prospective Study
Melasma is an acquired disorder of pigmentation that leads to irregular pigmented patches on the face. Treatment is difficult and to date the best treatment option is the combination of hydroquinone, retinoic acid and steroids combined in topical daily application (called Kligman's trio). Q-switched pigmentary lasers are usually ineffective and can induce post inflammatory hyperpigmentation (PIH). Intense pulsed light can sometimes improve melasma but also induce PIH which limit their use. Recently, pulsed dye laser were demonstrated to be effective in treating some pigmentary defects. Associating blanching cream with hydroquinone to prevent PIH after laser or intense pulsed light has been already reported with success.
The objective of the study is to compare in a prospective intra individual comparative trial the association of pulsed dye laser plus stabilized Kligman's trio to Kligman's trio alone. The secondary objective was to study the frequency and the intensity of the potential side effects including PIH.
- Conditions
- Melanosis
- Being tested
- pulsed dye laser treatment, Kligman's Trio
- Medical subject headings
- Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulsed dye laser treatmentProcedure or surgery
On one side of the face according to Arm placement.
Kligman's TrioDrug
The combination of hydroquinone, retinoic acid and steroids combined in topical daily application.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Active comparator | All patients will be treated by stabilized Kligman's trio with daily application during 4 months.
After one month, the left side of the face will be treated with pulsed dye laser at the rate of 3 sessions (one every weeks).
Applications of cream will be stopped on both side of the face for the 3 days following each laser session. Final visit will be scheduled 1 month after the end of applications of stabilized Kligman's trio.
All the patients will used a sunscreen indication 50 + for the duration of the entire study.
The patient is her own witness. They compare the hemiface treated without laser and the hemiface treated with the laser. Receives: Procedure: pulsed dye laser treatment; Drug: Kligman's Trio |
| Arm B | Active comparator | All patients will be treated by stabilized Kligman's trio at the rate of application in the evening during 4 months.
After one month, the side of the right face will be treated by pulsed dye laser at the rase of 3 sessions spaced out by 3 weeks each.
Applications will be stopped in the 3 days which will follow every session by laser with blown colouring agent. The patients will be seen again 1 month after the stopping of applications of stabilized Kligman's trio
All patients will be used a sunscreen indication 50 + for the duration of study.
The patient is her own witness. They compare the cheek treated without laser and the cheek treated with the laser. Receives: Procedure: pulsed dye laser treatment; Drug: Kligman's Trio |
What is being measured
The primary outcome is the main question the study is designed to answer.
MASI score, standardized photos in direct, crossed polarized and UV light, relating to the security: 0 yes 1 N0
Measured: visit of screening (V0), 15 days after V0 during the follow visit 1(V1), 3 weeks after V1 during the following visit 2(V2), 3 weeks after V2 during the following visit 3(V3), 10 weeks after V3 during the following visit 4
Secondary outcomes (1)
Clinical evaluation of potential side-effects (including post inflammatory pigmentation)
Measured: visit of screening (V0), 15 days after V0 during the follow visit 1(V1), 3 weeks after V1 during the following visit 2(V2), 3 weeks after V2 during the following visit 3(V3), 10 weeks after V3 during the following visit 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionMar 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- PASSERON Ph Thierry, MD, Principal investigator, CHU de Nice - Service de Dermatologie - Hôpital de l'Archet - 151 Route de saint-antoine de ginestière 06200 Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00863278
- Sponsor's protocol ID
- 08-PP-13
- Status last verified
- Jun 2009
- First submitted
- 16 Mar 2009
- Last updated
- 26 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Melasma With Stabilized Kligman Preparation Associated or Not With Pulsed Dye Laser; a Comparative Prospective Study
- ClinicalTrials.gov ID
- NCT00863278
- Acronym / sponsor ID
- 08-PP-13
- Conditions
- Melanosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 17 Mar 2009 (estimated)
- 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.
Melasma is an acquired disorder of pigmentation that leads to irregular pigmented patches on the face. Treatment is difficult and to date the best treatment option is the combination of hydroquinone, retinoic acid and steroids combined in topical daily application (called Kligman's trio). Q-switched pigmentary lasers are usually ineffective and can induce post inflammatory hyperpigmentation (PIH). Intense pulsed light can sometimes improve melasma but also induce PIH which limit their use. Recently, pulsed dye laser were demonstrated to be effective in treating some pigmentary defects. Associating blanching cream with hydroquinone to prevent PIH after laser or intense pulsed light has been already reported with success.
The objective of the study is to compare in a prospective intra individual comparative trial the association of pulsed dye laser plus stabilized Kligman's trio to Kligman's trio alone. The secondary objective was to study the frequency and the intensity of the potential side effects including PIH.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Active comparator | Procedure: pulsed dye laser treatment, Drug: Kligman's TrioAll patients will be treated by stabilized Kligman's trio with daily application during 4 months. After one month, the left side of the face will be treated with pulsed dye laser at the rate of 3 sessions (one every weeks). Applications of cream will be stopped on both side of the face for the 3 days following each laser session. Final visit will be scheduled 1 month after the end of applications of stabilized Kligman's trio. All the patients will used a sunscreen indication 50 + for the duration of the entire study. The patient is her own witness. They compare the hemiface treated without laser and the hemiface treated with the laser. |
| Arm B | Active comparator | Procedure: pulsed dye laser treatment, Drug: Kligman's TrioAll patients will be treated by stabilized Kligman's trio at the rate of application in the evening during 4 months. After one month, the side of the right face will be treated by pulsed dye laser at the rase of 3 sessions spaced out by 3 weeks each. Applications will be stopped in the 3 days which will follow every session by laser with blown colouring agent. The patients will be seen again 1 month after the stopping of applications of stabilized Kligman's trio All patients will be used a sunscreen indication 50 + for the duration of study. The patient is her own witness. They compare the cheek treated without laser and the cheek treated with the laser. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Pregnant women or breastfeeding.
- Skin type 5 or 6.
Key exclusion criteria (3 listed)
- Known allergy to the compounds of the Kligman preparation.
- Refusal to put very high protection sunscreen during the study.
- Concomitant use of topical products that might have an effect on melasma (topical steroids, retinoids, etc…)
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 |
|---|---|---|
| pulsed dye laser treatmentOn one side of the face according to Arm placement. | Procedure or surgery | Arm A, Arm B |
| Kligman's TrioThe combination of hydroquinone, retinoic acid and steroids combined in topical daily application. | Drug | Arm A, Arm B |
Primary outcome
MASI score, standardized photos in direct, crossed polarized and UV light, relating to the security: 0 yes 1 N0
Time frame: visit of screening (V0), 15 days after V0 during the follow visit 1(V1), 3 weeks after V1 during the following visit 2(V2), 3 weeks after V2 during the following visit 3(V3), 10 weeks after V3 during the following visit 4
1 secondary outcome
Clinical evaluation of potential side-effects (including post inflammatory pigmentation)
Time frame: visit of screening (V0), 15 days after V0 during the follow visit 1(V1), 3 weeks after V1 during the following visit 2(V2), 3 weeks after V2 during the following visit 3(V3), 10 weeks after V3 during the following visit 4
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2012.
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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.
PASSERON Ph Thierry, MD principal investigator
CHU de Nice - Service de Dermatologie - Hôpital de l'Archet - 151 Route de saint-antoine de ginestière 06200 Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing pulsed dye laser treatment and Kligman's Trio 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 2 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: stopped early, as of the sponsor's last update on 26 Mar 2012. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was stopped early. Results are not available in the source record.
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?
MASI score, standardized photos in direct, crossed polarized and UV light, relating to the security: 0 yes 1 N0 (time frame: visit of screening (V0), 15 days after V0 during the follow visit 1(V1), 3 weeks after V1 during the following visit 2(V2), 3 weeks after V2 during the following visit 3(V3), 10 weeks after V3 during the following visit 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Mar 2012.