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

• ClinicalTrials.gov Identifier: NCT04797663
• Recruitment Status: Completed
• First Posted: March 15, 2021
• Last Update Posted: August 3, 2021
• Sponsor: Cairo University
• Information provided by (Responsible Party): Dina Saadi, Cairo University

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.

Condition or disease	Intervention/treatment	Phase
Keratosis Pilaris	Device: Nd-YAG laser; Drug: TCA 20%	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Clinical and Dermoscopic Evaluation of Long-pulsed 1064 nm Nd-YAG Laser Versus Trichloroacetic Acid 20% in Treatment of Keratosis Pilaris
• Actual Study Start Date: March 17, 2021
• Actual Primary Completion Date: July 18, 2021
• Actual Study Completion Date: August 1, 2021

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Nd-YAG laser; laser hair removal	Device: Nd-YAG laser; laser hair removal device; Other Name: 1064 nm laser
Experimental: TCA 20%; chemical peel	Drug: TCA 20%; chemical peel; Other Name: Trichloroacetic acid

Outcome Measures

Primary Outcome Measures :

1. Change of clinical and dermoscopic scores of KP with Nd-YAG laser [ Time Frame: 4 months ]
   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
2. Change of clinical and dermoscopic scores of KP with TCA 20% [ Time Frame: 4 months ]
   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 :

1. safety and tolerability of Nd-YAG laser and TCA 20% in treatment of KP: adverse events [ Time Frame: 4 months ]
   adverse effects of treatment modalities, if any

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Egypt

Kasr Alainy

Cairo, Egypt, 11562

Sponsors and Collaborators

Cairo University

Investigators

• Principal Investigator: Akmal Saad, professor; Cairo University

More Information

• Responsible Party: Dina Saadi, principal investigator, Cairo University
• ClinicalTrials.gov Identifier: NCT04797663
• Other Study ID Numbers: las177
• First Posted: March 15, 2021
• Last Update Posted: August 3, 2021
• Last Verified: August 2021

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

Additional relevant MeSH terms:

Keratosis, Actinic; Abnormalities, Multiple; Darier Disease; Keratosis; Skin Diseases; Precancerous Conditions; Neoplasms; Congenital Abnormalities; Skin Diseases, Genetic; Genetic Diseases, Inborn