Long-pulsed 1064 nm Nd-YAG Laser Versus TCA 20% in Treatment of Keratosis Pilaris

Phase 4

Completed

• Conditions: Keratosis Pilaris
• Interventions: Device: Nd-YAG laser; Drug: TCA 20%

• Registration Number: NCT04797663
• Lead Sponsor: Cairo University

Brief Summary

Keratosis pilaris (KP) is a common disorder of keratinization. There are different treatment modalities for KP with variable results. Nd:YAG laser and chemical peels are among these treatment modalities, however, there is no enough evidence in the literature regarding their efficacy. The aim of this study is to assess and compare the efficacy of long pulsed Nd:YAG laser and trichloreacetic acid 20% in treatment of keratosis pilaris.

Detailed Description

Keratosis pilaris (KP) is a genetic disorder of keratinization of hair follicles of skin. It's a very common benign condition that manifests as small, rough folliculocentric keratotic papules, often described as chicken bumps, chicken skin or goose-bumps, in characteristic areas of body, particularly the outer upper arms and thighs.

Trichloreacetic acid (TCA) is a type of chemical peels that is derived from acetic acid by the chlorination of 3 hydrogen ions. It can induce coagulative necrosis of proteins and cells. The depth of action depends on various factors e.g the number of layers applied and its combination with substances that potentiate its action.

Nd: YAG laser is a type of hair removing devices that operates at wave length of 1064nm. This wave length allows for less absorption at the epidermis. It is less absorbed by melanin, which leads to lower side effect and better tolerance but less efficacy in dark skinned patients.

Study Timeline

• Study First Submitted: 2021-03-06
• Study First Submitted QC: 2021-03-12
• Study First Posted: 2021-03-15
• Study Start: 2021-03-17
• Primary Completion: 2021-07-18
• Status Verified: 2021-08
• Study Completion: 2021-08-01
• Last Update Submitted: 2021-08-01
• Last Update Posted: 2021-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

• Patients above 18 years with KP.
• Patients with KP affecting back of the trunk, arms, thighs, forearms, legs and buttocks.

Exclusion Criteria

• Pregnant or lactating females.
• Patients who had performed any laser treatment for KP within 6 months prior to the study.
• Patients with history of oral retinoids within 3 months prior to the study.
• Patients with history of hypertrophic scars or keloids.
• Patients who used any topical treatment one month prior to the session.
• Patients with acne affecting the same sites of keratosis pilaris.
• Patients with active skin diseases affecting the area involved with KP e.g. folliculitis and eczema.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nd-YAG laser	Nd-YAG laser	laser hair removal
TCA 20%	TCA 20%	chemical peel

Primary Outcome Measures

Name	Time	Method
Change of clinical and dermoscopic scores of KP with Nd-YAG laser	4 months	the change in roughness and color of KP by clinical score after 4 sessions of Nd-YAG laser. the score ranges from 0-4. where 0 is no change and 4 is excellent improvement
Change of clinical and dermoscopic scores of KP with TCA 20%	4 months	the change in roughness and color of KP by clinical score after 4 sessions of TCA 20% peel. the score ranges from 0-4. where 0 is no change and 4 is excellent improvement

Secondary Outcome Measures

Name	Time	Method
safety and tolerability of Nd-YAG laser and TCA 20% in treatment of KP: adverse events	4 months	adverse effects of treatment modalities, if any

Trial Locations

Locations (1)

Kasr Alainy; 🇪🇬 Cairo, Egypt