Comparison of 10 percent trichloroacetic acid and 35 percent glycolic acid peel in the treatment of periorbital hyperpigmentation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To compare the efficacy of 10% trichloroacetic acid peel and 35% glycolic acid peel in administered every three weeks for four sessions in the treatment of periorbital hyperpigmentation (aged 18-60) as assessed by dermoscopic and physician’s global assessment at pre- and post-12-week follow-up.
研究概览
简要总结
this study is a randomized interventions split face study , single blinded ,parallel group, single central trail comparing the efficacy and safety of trichloroacetic acid and glycolic acid peel in the treatment of periorbital hyper pigmentation for one year duration that study should be conducted on Dr Baba Saheb Ambedkar medical college and hospital Rohini Delhi India. the primary outcome measure the efficacy of trichloroacetic acid peel vs glycolic acid peel 3 weeks for four session 0,3,6,9 weeks and follow up after 12 weeks and dermoscope picture taken pre and post treatment and the secondary outcome will be safety and physician global assessment trichloroacetic acid peel vs glycolic acid peel in treatment of periorbital hyper pigmentation.
Inclusion criteria -All patient of age 18-60 years attending the outpatient department clinically diagnosed as periorbital hyperpigmentation and are willing to participate in the study after giving informed consent.
Exclusion criteria-
-
Patients on topical or systemic treatment for POH in the past 1 month
-
Patients with photosensitive disorders/on photosensitizing drugs
-
Inflammatory dermatoses on the face
-
Patients with unilateral POH
-
Patients with a history of keloid scarring
Pregnancy and lactation
- Active viral/bacterial/ infection on face
METHODOLOGY
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Patients clinically diagnosed with POH will be provided with a Patient information sheet and invited to participate in the study
-
Written informed consent will be taken from all the patients prior to inclusion in he study
inclusion in the study.
- Detailed demographic data and clinical history, including the onset, duration of POH, aggravating factors, treatment received, any prolonged
drug intake, cosmetic use, history of atopy, family history, and menstrual history of all the patients will be taken and recorded in a preset proforma.
-
Detailed examination of the face under good illumination will be conducted to assess the lesions, clinical type, and grade of POH.
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Clinical photographs (without revealing identity) using standardized position from forehead to malar area and dermoscopic photographs in both polarized and nonpolarized lights will be taken at 0, 3, 6, 9, and 12 weeks.
Procedure
-
Patients will be made to lie down in a reclining position. A postauricular patch test will be performed on each patient 15 minutes prior to the peeling session. After the test peel, the area to be treated will be degreased with a 50% alcohol solution.
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10% of TCA will be applied on the right side with a cotton-tipped applicator in the infraorbital areas until the appearance of frosting.
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Similarly, on the left side 35% GA will be applied, and neutralized with saline after 2 minutes.
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After neutralising both peels with saline, patients will be asked to apply sunscreen with sun protection factor 30 on their faces before stepping out
of the hospital.
-
They will be instructed to apply sunscreen regularly.
-
The peeling will be done at an interval of 3 weeks on week 0,3,6,9, for a
total of four sessions and followed up on week 12.
- Single blinding will be done.
Physician’s global assessment
The improvement will be evaluated by means of photographs by the
dermatologist using the following grading scale at 12 weeks of follow up.
Patient’s global assessment-
Patient assessment will be graded as poor, fair, good, and excellent at 12 weeks follow-up by the patient on a similar scale as the Physician’s Global Assessment.
Periorbital hyperpigmentation grading
The degree of improvement in periorbital pigmentation will be done by Periorbital
hyperpigmentation (POH) grading as
0 – Skin colour comparable to other facial skin areas 1 – Faint pigmentation of infraorbital fold. 2 – Pigmentation more pronounced. 3 – Deep dark colour, all four lids involved. 4 – Grade 3 + pigmentation spreading beyond the infraorbital fold.
Dermoscopic examination
Dermoscopic examination finding Right eye Left eye
0 week 12 weeks with following pattern
Epidermal-
Homogeneous light brown
Cobble stone
Homogeneous light brown with
speckled
Dermal
Speckled
Globules
Cobblestone
Mixed (epidermal and dermal)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •All patient age 18-60 years attending the outpatient department clinically diagnosed as periorbital hyperpigmentation and are willing to participate in the study after giving informed consent.
排除标准
- •1.Patients on topical steroid or systemic treatment for POH In the past 1 month.
- •2.Patients with photosensitive disorder/photosensitizing drug 3.Inflammatory dermatoses on the face 4.Patients with unilateral POH 5.Patients with history of keloid scaring 6.Pregnancy and lactation 7.Active viral/bacterial/infection on face.
结局指标
主要结局
To compare the efficacy of 10% trichloroacetic acid peel and 35% glycolic acid peel in administered every three weeks for four sessions in the treatment of periorbital hyperpigmentation (aged 18-60) as assessed by dermoscopic and physician’s global assessment at pre- and post-12-week follow-up.
时间窗: 0,3,6,9 and 12 weeks follow up
次要结局
- •To compare the safety of 10% trichloroacetic peel and 35% glycolic acid peel in patients studied.(• To evaluate physician global assessment feature in clinical subtype of periorbital hyperpigmentation in patient included this study.)
研究者
Bijendra Singh
dr baba saheb ambedker medical college and hospital
