MelasmaPhase 4NCT00166192
Treatment of Melasma With Jessner's Solution vs. Trichloroacetic Acid
A Phase 4 study testing Jessner's solution chemical peel and Trichloroacetic acid chemical peel in people with Melasma, run by Emory University at 1 site in United States.
Trial summary
Melasma is an acquired discoloration of the skin characterized by brown patches. Chemical peels using agents such as Jessner's solution and trichloroacetic acid (TCA) are commonly used to treat melasma. A chemical peel involves applying the peeling agent to the skin for a short period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melasma
- What is being tested?
- Jessner's solution chemical peel and Trichloroacetic acid chemical peel
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Nov 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults > 18 years old
- Clinical diagnosis of melasma
- Mental capacity to give informed consent
Who cannot join
- Pregnancy
- H/o allergy to Jessner's solution, tricholoracetetic acid, tretinoin, or hydroquinone
- Active dermatitis
- Presence of cutaneous infection
Trial locations and contacts
1 site in 1 country.
United States1 site
Emory University Dermatology Clinic
Atlanta, Georgia, 30322
About this study
Official title: Treatment of Melasma With Jessner's Solution vs. Trichloroacetic Acid: A Comparison of Clinical Efficacy
Melasma is an acquired discoloration of the skin characterized by brown patches. Chemical peels using agents such as Jessner's solution and trichloroacetic acid (TCA) are commonly used to treat melasma. A chemical peel involves applying the peeling agent to the skin for a short period. The skin will peel similar to a sunburn, and moisturizers are applied to the skin. Although both agents are well-accepted, there have been no good comparisons of the two agents. The purpose of this study is determine if there is a difference in the effectiveness of these two agents.
- Conditions
- Melasma
- Being tested
- Jessner's solution chemical peel, Trichloroacetic acid chemical peel
- Keywords
- Melasma, Jessner's solution, Trichloroacetic acid (TCA)
- Medical subject headings
- Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jessner's solution chemical peelProcedure or surgery
Trichloroacetic acid chemical peelProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Chemical Peel | Active comparator | Split face treatment paradigm Receives: Procedure: Jessner's solution chemical peel; Procedure: Trichloroacetic acid chemical peel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical efficacy by clinician's evaluation
Hyperpigmenation Global Score
Measured: 3 months
Secondary outcomes (1)
Efficacy by subject's evaluation
Hyperpigmentation Global Score
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startJan 2008
- Primary completionJan 2010
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelasmaStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zakiya Rice, Emory University
- Investigators
- Carl Washington, MD, Principal investigator, Emory University Department of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00166192
- Sponsor's protocol ID
- IRB00024850
- Status last verified
- Nov 2013
- First submitted
- 13 Sep 2005
- Last updated
- 14 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Melasma With Jessner's Solution vs. Trichloroacetic Acid: A Comparison of Clinical Efficacy
- ClinicalTrials.gov ID
- NCT00166192
- Acronym / sponsor ID
- IRB00024850
- Conditions
- Melasma
- Keywords
- Melasma, Jessner's solution, Trichloroacetic acid (TCA)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 14 Sep 2005 (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 discoloration of the skin characterized by brown patches. Chemical peels using agents such as Jessner's solution and trichloroacetic acid (TCA) are commonly used to treat melasma. A chemical peel involves applying the peeling agent to the skin for a short period. The skin will peel similar to a sunburn, and moisturizers are applied to the skin. Although both agents are well-accepted, there have been no good comparisons of the two agents. The purpose of this study is determine if there is a difference in the effectiveness of these two agents.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chemical Peel | Active comparator | Procedure: Jessner's solution chemical peel, Procedure: Trichloroacetic acid chemical peelSplit face treatment paradigm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults > 18 years old
- Clinical diagnosis of melasma
- Mental capacity to give informed consent
Key exclusion criteria (4 listed)
- Pregnancy
- H/o allergy to Jessner's solution, tricholoracetetic acid, tretinoin, or hydroquinone
- Active dermatitis
- Presence of cutaneous infection
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 |
|---|---|---|
| Jessner's solution chemical peel | Procedure or surgery | Chemical Peel |
| Trichloroacetic acid chemical peel | Procedure or surgery | Chemical Peel |
Primary outcome
Clinical efficacy by clinician's evaluation
Time frame: 3 months
Hyperpigmenation Global Score
1 secondary outcome
Efficacy by subject's evaluation
Time frame: 3 months
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 14 Nov 2013.
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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.
Carl Washington, MD principal investigator
Emory University Department of Dermatology
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 Jessner's solution chemical peel and Trichloroacetic acid chemical peel in people with Melasma, run by Emory University at 1 site in United States.
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 3 inclusion and 4 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 14 Nov 2013. 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 United States. 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 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?
Clinical efficacy by clinician's evaluation (time frame: 3 months). 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 14 Nov 2013.