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

Clinical and Dermoscopic Evaluation of Long-pulsed 1064 nm Nd-YAG Laser Versus Trichloroacetic Acid 20% in Treatment of Keratosis Pilaris

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.

Study Overview

• Status: Completed
• Conditions: Keratosis Pilaris
• Intervention / Treatment: Device: Nd-YAG laser; Drug: TCA 20%

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11562
    • Kasr Alainy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Nd-YAG laser; laser hair removal	Device: Nd-YAG laser; laser hair removal device; Other Names: 1064 nm laser
Experimental: TCA 20%; chemical peel	Drug: TCA 20%; chemical peel; Other Names: Trichloroacetic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of clinical and dermoscopic scores of KP with Nd-YAG laser	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	4 months
Change of clinical and dermoscopic scores of KP with TCA 20%	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	4 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Akmal Saad, professor, Cairo University

Publications and helpful links

General Publications

• Hassan AS, Abdel Aziz M, Saadi DG. Clinical and Dermoscopic Evaluation of Trichloroacetic Acid 20% Versus Long-Pulsed 1064-nm Nd-YAG Laser in the Treatment of Keratosis Pilaris. Dermatol Surg. 2022 Aug 1;48(8):838-842. doi: 10.1097/DSS.0000000000003488. Epub 2022 Jun 15.

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2021
• Primary Completion (Actual): July 18, 2021
• Study Completion (Actual): August 1, 2021

Study Registration Dates

• First Submitted: March 6, 2021
• First Submitted That Met QC Criteria: March 12, 2021
• First Posted (Actual): March 15, 2021

Study Record Updates

• Last Update Posted (Actual): August 3, 2021
• Last Update Submitted That Met QC Criteria: August 1, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Congenital Abnormalities; Genetic Diseases, Inborn; Skin Diseases, Genetic; Precancerous Conditions; Keratosis, Actinic; Keratosis; Abnormalities, Multiple; Darier Disease
• Other Study ID Numbers: las177

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes