NCT03238105|UnknownPhase 4
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Sponsor study identifier
interventional
29
1 country
1
Study Start
August 1, 2017
Actual (reported)Primary Completion
February 10, 2020
Actual (reported)Study Completion
December 31, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Periorbital hyperchromia (POH) or periorbital hyperpigmentation, commonly known as "dark circles", is a relatively common condition and a frequent reason for dermatological consultation. It is defined as brown-colored pigmentation, ranging from light to dark, which mainly involves the lower eyelids. POH affects individuals over a wide age range, including both sexes and all ethnicities, and is associated with a tired and aged facial appearance. The most commonly affected people are those with the highest skin phototypes. Although the prevalence is similar between sexes and age groups, POH is a more frequent complaint in women. The dark circles characteristic of POH can negatively impact patients' quality of life, although it is not a condition associated with morbidity. Despite its high prevalence, only a few well-designed studies were done to evaluate its therapeutic options. The intense pulsed light (IPL) and the thioglycolic acid are safe treatment options and promote the improvement of dark circles, but it is not known if one treatment differs from the other in relation to efficacy and adverse effects.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 1, 2017
Actual (reported)August 1, 2017
Actual (reported)August 3, 2017
Actual (reported)February 10, 2020
Actual (reported)December 31, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Clinical response and compare treatment results
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
Quality of Life Index in Dermatology
5 months
Pittsburgh Sleep Quality Index
at 1 day visit 1
Adverse effects
5 months
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.
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.
Monthly sessions for 3 months.
Contact the study team to confirm eligibility.
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-003, Brazil
Juliana C Boza, PhD
Hospital de Clinicas de Porto Alegre
First Submitted
August 1, 2017
First Posted
August 3, 2017
Study Start
Intense Pulsed Light Therapy in Meibomian Gland Dysfunction
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
August 1, 2017
Primary Completion
February 10, 2020
Actual (reported)Study Completion
December 31, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
February 12, 2020
Record last verified: 2020-02
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Source: ClinicalTrials.gov.
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