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

Keratosis Pilaris Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04797663
• Other study ID #: las177
• Status: Completed
• Phase: Phase 4
• Start date: March 17, 2021
• Est. completion date: August 1, 2021

Study information

• Verified date: August 2021
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 1, 2021
• Est. primary completion date: July 18, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Abnormalities, Multiple
• Darier Disease
• Keratosis
• Keratosis Pilaris
• Keratosis, Actinic

Intervention

Device:
• Nd-YAG laser
laser hair removal device

Drug:
• TCA 20%
chemical peel

Locations

Country	Name	City	State
Egypt	Kasr Alainy	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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