- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03238105
Treatment of Periorbicular Hyperchromia Comparing 10% Thioglycolic Acid Peeling Versus Pulsed Intense Light
Treatment of Periorbicular Hyperchromia Comparing 10% Thioglycolic Acid Peeling Versus Pulsed Intense Light: a Randomized Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
It is a blinded randomized clinical trial, with the sample size calculated of 29 subjects, already considering 10% of possible losses and refusals. For this number was considered 80% power and significance level of 5%.
Selected patients will be invited to participate and informed about the characteristics of the study. If they do, they must sign a free and informed consent form.
At the first visit, some demographic data will be collected, including sex, age, phototype, history of smoking and / or alcohol consumption, family history of periocular hyperpigmentation, personal or family history of allergies and hours of sleep, for instance.Photographic registration will be done in a standardized way. After completion of the study, the photographs will be evaluated blindly by two evaluators, and they will not know before what therapeutic modality was adopted in each periorbital region. Clinical evaluation will be obtained through the application of the Global Aesthetic Improvement Scale (with the following grades: much better, better, better, no change, worse) and visual analogue scale for clinical improvement from 0 (no improvement) to 10 (complete improvement), both with monthly evaluations. Each patient will be submitted to the two proposed therapies, being a therapeutic procedure in the right periocular region and another in the left periocular region. Each periocular region will be randomized using the random.org program for treatment with 10% thioglycolic acid peeling or IPL. Both therapies will be performed at the same time in the monthly visits, totaling 3 months of treatment (3 sessions of IPL and 3 sessions of thioglycolic acid). The first visit will be for collection of demographic data, physical examination record, colorimetry and questionnaire completion. Visits 2, 3 and 4 will be for the treatments and the visit in month 5 will be for evaluation of the results.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
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Rio Grande Do Sul
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Porto Alegre, Rio Grande Do Sul, Brazil, 90035-003
- Hospital de Clinicas de Porto Alegre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with periocular hyperchromia diagnosed by clinical examination. The volunteers included must have a pigmentary component, which may or may not present the anatomical component, determined through physical examination with the aid of dermoscopy, to be performed at the inclusion study visit.
Exclusion Criteria:
- Pregnant patients, active collagenase patients, patients using photosensitizing substances and areas with bacterial or viral infections, patients with scars or tattoos at the evaluated site, patients undergoing any treatment modality for periocular hyperpigmentation in the last 3 months.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intense pulsed light
The application model will be 3 months of treatment with monthly interval between sessions, totaling 3 sessions.
The parameters are as follows: frequency 15 J / cm2, pulse duration 15 ms, 1-2 passed as erythema.
Eye protection for IPL will be used during all sessions.
|
Monthly sessions for 3 months.
Other Names:
|
Experimental: Peeling of 10% thioglycolic acid
In the first session the acid will be applied for three minutes, and with each new session the duration time with the product will increase in three minutes, so that in the last session the duration of the application will be 9 minutes.
For the application of the product will be used flexible cotton rod, sparing the region just below the eyelids of the lower eyelid 0.5cm, therefore, no other measure is necessary for eye protection.
After the given time, the substance will be removed with lint with 0.9% saline solution.
|
Monthly sessions for 3 months with progressive increase of the duration of contact time of the drug with the skin, 3, 6 and 9 minutes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical response and compare treatment results
Time Frame: 5 months
|
Through photographs the blinded evaluators will classify the difference on each side (right or left) using the Global Aesthetic Improvement (GAIS) scale.
The evaluation will be comparing photographs before treatment with photographs after treatment.
The data will be compared between the 2 treatments to evaluate if there was difference between them.
|
5 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of Life Index in Dermatology
Time Frame: 5 months
|
To evaluate the impact of periocular hyperpigmentation on patients' dermatological quality of life before and after treatments.
|
5 months
|
Pittsburgh Sleep Quality Index
Time Frame: at 1 day visit 1
|
To evaluate the sleep quality on patients with periocular hyperpigmentation.
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at 1 day visit 1
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Adverse effects
Time Frame: 5 months
|
To evaluate the immediate, early and late adverse effects related to the proposed treatments through questionnaires after each session and before the next session
|
5 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 48653215.5.0000.5327
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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