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

NCT04797663 | Completed Phase 4 FDA Drug FDA Device

• 1 other identifier: las177
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Keratosis Pilaris

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• safety and tolerability of Nd-YAG laser and TCA 20% in treatment of KP: adverse events

  4 months

Study Arms (2)

Nd-YAG laser

ACTIVE COMPARATOR

laser hair removal

Device: Nd-YAG laser

TCA 20%

EXPERIMENTAL

chemical peel

Drug: TCA 20%

Interventions

Nd-YAG laser DEVICE

laser hair removal device

Also known as: 1064 nm laser

Nd-YAG laser

TCA 20% DRUG

chemical peel

Also known as: Trichloroacetic acid

TCA 20%

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Alainy

Cairo, 11562, Egypt

Location

Related Publications (1)

• 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.

  PMID: 35917264 DERIVED

MeSH Terms

Conditions

Burnett Schwartz Berberian syndrome

Interventions

Lasers, Solid-State; Lasers; Trichloroacetic Acid

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies; Chloroacetates; Acetates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydrocarbons, Chlorinated; Hydrocarbons, Halogenated; Hydrocarbons

Study Officials

• Akmal Saad, professor

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: March 6, 2021
• First Posted: March 15, 2021
• Study Start: March 17, 2021
• Primary Completion: July 18, 2021
• Study Completion: August 1, 2021
• Last Updated: August 3, 2021

Record last verified: 2021-08

Locations

EG (1)