Treatment of Periorbicular Hyperchromia Comparing 10% Thioglycolic Acid Peeling Versus Pulsed Intense Light

NCT03238105 | Unknown Phase 4

• 1 other identifier: 48653215.5.0000.5327
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Periorbital Disorder

Keywords

Dark circles; Periorbital hyperchromia; Facial aesthetics

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Quality of Life Index in Dermatology

  5 months

• Pittsburgh Sleep Quality Index

  at 1 day visit 1

• Adverse effects

  5 months

Study Arms (2)

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.

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.

Drug: Thioglycolic Acid

Interventions

Thioglycolic Acid DRUG

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.

Peeling of 10% thioglycolic acid

Intense Pulsed Light DEVICE

Monthly sessions for 3 months.

Also known as: IPL

Intense pulsed light

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-003, Brazil

Location

MeSH Terms

Interventions

2-mercaptoacetate; Intense Pulsed Light Therapy

Intervention Hierarchy (Ancestors)

Phototherapy; Therapeutics

Study Officials

• Juliana C Boza, PhD

  Hospital de Clínicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: There will be 2 blinded evaluators who will not know which side of the periorbital hyperchromia (right or left) received which treatment (IPL or peeling of 10% thioglycolic acid). They will do the evaluation through photographs, comparing the photos before the treatments with the photos after 1, 2 and 3 sessions after the treatments, without knowing what therapeutic modality was adopted in each periorbital region.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The selected patients will have each region of periorbital hyperchromia (right and left) randomized to one of the treatments (split face study).

Study Record Dates

• First Submitted: August 1, 2017
• First Posted: August 3, 2017
• Study Start: August 1, 2017
• Primary Completion: February 10, 2020
• Study Completion: December 31, 2020
• Last Updated: February 12, 2020

Record last verified: 2020-02

Locations

BR (1)