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临床试验/CTRI/2025/08/093240
CTRI/2025/08/093240尚未招募不适用

Comparison of 10 percent trichloroacetic acid and 35 percent glycolic acid peel in the treatment of periorbital hyperpigmentation

Dr Baba Saheb Ambedkar medical college and hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年8月30日最近更新:

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

  1. Patients clinically diagnosed with POH will be provided with a Patient information sheet and invited to  participate in the study

  2. Written informed consent will be taken from all the patients prior to inclusion in he study

inclusion in the study.

  1. 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.

  1. Detailed examination of the face under good illumination will be conducted to assess the lesions, clinical type, and grade of POH.

  2. 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

  1. 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.

  2. 10% of TCA will be applied on the right side with a cotton-tipped applicator in the infraorbital areas until the appearance of frosting.

  3. Similarly, on the left side 35% GA will be applied, and neutralized with saline after 2 minutes.

  4. 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.

  1. They will be instructed to apply sunscreen regularly.

  2. 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.

  1. 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

发起方
Dr Baba Saheb Ambedkar medical college and hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Bijendra Singh

dr baba saheb ambedker medical college and hospital

研究点 (1)

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