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

Primary Purpose

Keratosis Pilaris

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Nd-YAG laser
TCA 20%
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keratosis Pilaris

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Kasr Alainy

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Nd-YAG laser

TCA 20%

Arm Description

laser hair removal

chemical peel

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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

Full Information

First Posted
March 6, 2021
Last Updated
August 1, 2021
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04797663
Brief Title
Long-pulsed 1064 nm Nd-YAG Laser Versus TCA 20% in Treatment of Keratosis Pilaris
Official Title
Clinical and Dermoscopic Evaluation of Long-pulsed 1064 nm Nd-YAG Laser Versus Trichloroacetic Acid 20% in Treatment of Keratosis Pilaris
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
March 17, 2021 (Actual)
Primary Completion Date
July 18, 2021 (Actual)
Study Completion Date
August 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratosis Pilaris

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nd-YAG laser
Arm Type
Active Comparator
Arm Description
laser hair removal
Arm Title
TCA 20%
Arm Type
Experimental
Arm Description
chemical peel
Intervention Type
Device
Intervention Name(s)
Nd-YAG laser
Other Intervention Name(s)
1064 nm laser
Intervention Description
laser hair removal device
Intervention Type
Drug
Intervention Name(s)
TCA 20%
Other Intervention Name(s)
Trichloroacetic acid
Intervention Description
chemical peel
Primary Outcome Measure Information:
Title
Change of clinical and dermoscopic scores of KP with Nd-YAG laser
Description
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
Time Frame
4 months
Title
Change of clinical and dermoscopic scores of KP with TCA 20%
Description
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
Time Frame
4 months
Secondary Outcome Measure Information:
Title
safety and tolerability of Nd-YAG laser and TCA 20% in treatment of KP: adverse events
Description
adverse effects of treatment modalities, if any
Time Frame
4 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Akmal Saad, professor
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kasr Alainy
City
Cairo
ZIP/Postal Code
11562
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
35917264
Citation
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.
Results Reference
derived

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

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