MelasmaPhase 4NCT00616239

Salicylic Acid Peels Combined With 4% Hydroquinone in the Treatment of Moderate to Severe Melasma in Hispanic Women

A Phase 4 study testing 20-30% Salicylic Acid peels to the right side of the face and 20-30% Salicylic Acid peels to the left side of the face in people with Melasma, run by University of Texas Southwestern Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years, women only
Conditions the study is for: Melasma
What is being tested?: 20-30% Salicylic Acid peels to the right side of the face and 20-30% Salicylic Acid peels to the left side of the face
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited States
Study dates: Jan 2008to Mar 2018
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 65 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Hispanic women ages 18-65 years of age with moderate to severe melasma
English and Spanish-speaking women

Who cannot join

Pregnant or breast-feeding women
Subjects who have used 4% hydroquinone within 3 months of study start
Subjects who have used chemical peels, microdermabrasion or facial laser treatments within 9 months of study start

Trial locations and contacts

1 site in 1 country.

United States1 site

UT Southwestern Medical Center at Dallas - Dermatology Clinical Trials
Dallas, Texas, 75390-8802

Other trials in United States

About this study

Official title: The Efficacy of Salicylic Acid Peels Combined With 4% Hydroquinone Cream Versus 4% Hydroquinone Cream Alone in the Treatment of Hispanic Women With Moderate to Severe Melasma

This study will enroll 20 adult Hispanic women. Participants will apply 4% hydroquinone cream twice daily to affected areas on the face for 14 weeks and half the face will be peeled with 20-30% salicylic acid every two weeks for a total of 4 peels. The first two peels will be 20% salicylic acid and the second two peels will be with 30% salicylic acid. The purpose of the study will be to evaluate the safety and efficacy of salicylic acid combined with 4% hydroquinone versus 4% hydroquinone alone.

Conditions: Melasma
Being tested: 20-30% Salicylic Acid peels to the right side of the face, 20-30% Salicylic Acid peels to the left side of the face
Keywords: Melasma, Dark spots on the face
Medical subject headings: Melanosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

20-30% Salicylic Acid peels to the right side of the faceDrug
Also called Chemical Peels
Two 20% salicylic acid peels two weeks apart followed by 2 30% salicylic acid peels two weeks apart to the right side of the face.
20-30% Salicylic Acid peels to the left side of the faceDrug
Also called Chemical Peels
Two 20% salicylic acid peels two weeks apart followed by 2 30% salicylic acid peels two weeks apart to the left side of the face

Study groups in NCT00616239
Study group	Role	What they receive
A	Active comparator	Subjects randomized to have the right side of the face peeled with salicylic acid every 2 weeks for a total of 4 peels (first 2 at 20% and last 2 at 30%). Subjects will apply 4% hydroquinone cream to affected areas on entire face for 14 weeks. Receives: Drug: 20-30% Salicylic Acid peels to the right side of the face
B	Active comparator	Subjects randomized to have the left side of the face peeled with salicylic acid every 2 weeks for a total of 4 peels (first 2 at 20% and last 2 at 30%). Subjects will apply 4% hydroquinone cream to affected areas on entire face for 14 weeks. Receives: Drug: 20-30% Salicylic Acid peels to the left side of the face

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Showing Improvement of Melasma Based on Mexameter Readings
Improvement of melasma on the peel side using mexameter reading
Measured: 14 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2008Mar 2018

First posted15 Feb 2008 (estimated)
Study startJan 2008
Primary completionMar 2018
Study completionMar 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for MelasmaStudies of the same condition, open and under way.
More trials run by University of Texas Southwestern Medical CenterThe 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: Single group
Masking: Single blind
Who is masked: Investigator
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00616239
Sponsor's protocol ID: 082007-078
Other IDs: IRB File 082007-078
Status last verified: Jul 2020
First submitted: 4 Feb 2008
Last updated: 10 Aug 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Efficacy and Safety of Triple-Combination Cream Plus Microneedling Along With Tranexamic Acid Versus Platelet-Rich Plasma in the Treatment of Moderate-to-Severe Melasma: A Randomized Comparative Study
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All Melasma trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Efficacy of Salicylic Acid Peels Combined With 4% Hydroquinone Cream Versus 4% Hydroquinone Cream Alone in the Treatment of Hispanic Women With Moderate to Severe Melasma
ClinicalTrials.gov ID: NCT00616239
Acronym / sponsor ID: 082007-078
Conditions: Melasma
Keywords: Melasma, Dark spots on the face
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: University of Texas Southwestern Medical CenterUniversity, hospital or other
Study start: Jan 2008
Primary completion: Mar 2018 (actual)
Study completion: Mar 2018 (actual)
First posted: 15 Feb 2008 (estimated)
Results: Posted 30 Dec 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
A	Active comparator	Drug: 20-30% Salicylic Acid peels to the right side of the faceSubjects randomized to have the right side of the face peeled with salicylic acid every 2 weeks for a total of 4 peels (first 2 at 20% and last 2 at 30%). Subjects will apply 4% hydroquinone cream to affected areas on entire face for 14 weeks.
B	Active comparator	Drug: 20-30% Salicylic Acid peels to the left side of the faceSubjects randomized to have the left side of the face peeled with salicylic acid every 2 weeks for a total of 4 peels (first 2 at 20% and last 2 at 30%). Subjects will apply 4% hydroquinone cream to affected areas on entire face for 14 weeks.

Who may qualify

Ages: 18 to 65 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Hispanic women ages 18-65 years of age with moderate to severe melasma
English and Spanish-speaking women

Key exclusion criteria (3 listed)

Pregnant or breast-feeding women
Subjects who have used 4% hydroquinone within 3 months of study start
Subjects who have used chemical peels, microdermabrasion or facial laser treatments within 9 months of study start

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
20-30% Salicylic Acid peels to the right side of the faceAlso: Chemical PeelsTwo 20% salicylic acid peels two weeks apart followed by 2 30% salicylic acid peels two weeks apart to the right side of the face.	Drug	A
20-30% Salicylic Acid peels to the left side of the faceAlso: Chemical PeelsTwo 20% salicylic acid peels two weeks apart followed by 2 30% salicylic acid peels two weeks apart to the left side of the face	Drug	B

Primary outcome

Number of Participants Showing Improvement of Melasma Based on Mexameter Readings
Time frame: 14 weeks
Improvement of melasma on the peel side using mexameter reading

Results and safety

Results posted to the registry on 30 Dec 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
20% to 30% Salicylic Acid Peels + 4% Hydroquinone Cream	20	18

Primary outcome: Number of Participants Showing Improvement of Melasma Based on Mexameter Readings

Time frame: 14 weeks. Number. Unit: participants

Measure	20% to 30% Salicylic Acid Peels + 4% Hydroquinone Cream n = 18
Value	18

Adverse events

Time frame: Adverse event data was collected over the duration of the study, ie; from screening till the last day of the follow up period, an average of 14 weeks.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
20% to 30% Salicylic Acid Peels + 4% Hydroquinone Cream	0 of 20 (0%)	4 of 20 (20%)	0 of 20

Limitations and caveats (from the sponsor): Two subjects did not complete the study were unable to come in for visits because of scheduling difficulties and had no adverse effects at the time of discontinuation.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Melasma

Enrolling by invitationPhase 4
Microneedling-Assisted Metformin, Tranexamic Acid, and Modified Kligman's Formula for Melasma
Melasma (Facial Melasma)
Active, not recruitingPhase 4
Efficacy and Safety of Triple-Combination Cream Plus Microneedling Along With Tranexamic Acid Versus Platelet-Rich Plasma in the Treatment of Moderate-to-Severe Melasma: A Randomized Comparative Study
Melasma (Facial Melasma)
Not yet recruiting
COMPARISON OF TOPICAL VITAMIN C VS NIACINAMIDE IN TREATMENT OF MELASMA
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Not yet recruiting
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Not yet recruitingPhase 4
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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.

Amit Pandya, M.D. principal investigator

UT Southwestern Medical Center at Dallas - Department of Dermatology

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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: finished, as of the sponsor's last update on 10 Aug 2020. 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?

Yes. Results are posted in the registry (first posted 30 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants Showing Improvement of Melasma Based on Mexameter Readings (time frame: 14 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 NCT00616239.

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 10 Aug 2020.