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
About this trial
This is an interventional treatment trial for Keratosis Pilaris
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.
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
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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