Long-pulsed 1064 nm Nd-YAG Laser Versus TCA 20% in Treatm... | NCT04797663

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

NCT04797663

Sponsor

Cairo University

Status

Completed

Last Update Posted

Aug 3, 2021Actual

Enrollment

20Actual

Phase

Phase 4

Conditions

Keratosis Pilaris

Interventions

Nd-YAG laser
TCA 20%

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Mar 17, 2021Actual

Primary Completion Date

Jul 18, 2021Actual

Completion Date

Aug 1, 2021Actual

First Submitted Date

Mar 6, 2021

First Submission Date that Met QC Criteria

Mar 12, 2021

First Posted Date

Mar 15, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 1, 2021

Last Update Posted Date

Aug 3, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dina Saadi, principal investigator, Cairo UniversityPrincipal Investigator

Lead Sponsor

Cairo UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nd-YAG laser	Active Comparator	laser hair removal	Device: Nd-YAG laser
TCA 20%	Experimental	chemical peel	Drug: TCA 20%

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nd-YAG laser	Device	laser hair removal device	Nd-YAG laser	1064 nm laser

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Akmal Saad, professor	Cairo University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kasr Alainy		Cairo		11562	Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35917264	Derived	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.

ID	Term
D053844	Lasers, Solid-State
D007834	Lasers
D014238	Trichloroacetic Acid

ID	Term
D055096	Optical Devices
D004864	Equipment and Supplies
D055618	Radiation Equipment and Supplies
D062845	Chloroacetates