Periorbital DisorderPhase 4NCT03238105
Treatment of Periorbicular Hyperchromia Comparing 10% Thioglycolic Acid Peeling Versus Pulsed Intense Light
A Phase 4 study testing Thioglycolic Acid and Intense Pulsed Light in people with Periorbital Disorder, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periorbital Disorder
- What is being tested?
- Thioglycolic Acid and Intense Pulsed Light
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Aug 2017to 31 Dec 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-003
About this study
Official title: Treatment of Periorbicular Hyperchromia Comparing 10% Thioglycolic Acid Peeling Versus Pulsed Intense Light: a Randomized Trial
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.
Read the 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.
- Conditions
- Periorbital Disorder
- Being tested
- Thioglycolic Acid, Intense Pulsed Light
- Keywords
- Dark circles, Periorbital hyperchromia, Facial aesthetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thioglycolic AcidDrug
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.
Intense Pulsed LightDevice
Also called IPL
Monthly sessions for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Intense pulsed light | Experimental | 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. Receives: Device: Intense Pulsed Light |
| Peeling of 10% thioglycolic acid | Experimental | 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. Receives: Drug: Thioglycolic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 months
Secondary outcomes (3)
Quality of Life Index in Dermatology
To evaluate the impact of periocular hyperpigmentation on patients' dermatological quality of life before and after treatments.
Measured: 5 months
Pittsburgh Sleep Quality Index
To evaluate the sleep quality on patients with periocular hyperpigmentation.
Measured: at 1 day visit 1
Adverse effects
To evaluate the immediate, early and late adverse effects related to the proposed treatments through questionnaires after each session and before the next session
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2017
- Study start1 Aug 2017
- Primary completion10 Feb 2020
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periorbital DisorderStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe 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
- Model description
- The selected patients will have each region of periorbital hyperchromia (right and left) randomized to one of the treatments (split face study).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juliana C Boza, PhD, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03238105
- Sponsor's protocol ID
- 48653215.5.0000.5327
- Status last verified
- Feb 2020
- First submitted
- 1 Aug 2017
- Last updated
- 12 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Periorbicular Hyperchromia Comparing 10% Thioglycolic Acid Peeling Versus Pulsed Intense Light: a Randomized Trial
- ClinicalTrials.gov ID
- NCT03238105
- Acronym / sponsor ID
- 48653215.5.0000.5327
- Conditions
- Periorbital Disorder
- Keywords
- Dark circles, Periorbital hyperchromia, Facial aesthetics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 10 Feb 2020 (actual)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 3 Aug 2017 (actual)
- 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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The selected patients will have each region of periorbital hyperchromia (right and left) randomized to one of the treatments (split face study).
| Arm | Type | Receives |
|---|---|---|
| Intense pulsed light | Experimental | Device: Intense Pulsed LightThe 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. |
| Peeling of 10% thioglycolic acid | Experimental | Drug: Thioglycolic AcidIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| Thioglycolic AcidMonthly sessions for 3 months with progressive increase of the duration of contact time of the drug with the skin, 3, 6 and 9 minutes. | Drug | Peeling of 10% thioglycolic acid |
| Intense Pulsed LightAlso: IPLMonthly sessions for 3 months. | Device | Intense pulsed light |
Primary outcome
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.
3 secondary outcomes
Quality of Life Index in Dermatology
Time frame: 5 months
Pittsburgh Sleep Quality Index
Time frame: at 1 day visit 1
Adverse effects
Time frame: 5 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2020.
- Individual participant dataSharing planned: Undecided
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.
Juliana C Boza, PhD principal investigator
Hospital de Clinicas de Porto Alegre
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 Thioglycolic Acid and Intense Pulsed Light in people with Periorbital Disorder, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 12 Feb 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 Brazil. 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?
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?
Clinical response and compare treatment results (time frame: 5 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 12 Feb 2020; AzTrials last refreshed its copy on 7 Nov 2026.