Clinical trial NCT04797663: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Keratosis Pilaris
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-03-15
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change of clinical and dermoscopic scores of KP with Nd-YAG laser
timeFrame: 4 months
measure: Change of clinical and dermoscopic scores of KP with TCA 20%
timeFrame: 4 months
Secondary outcomes:
measure: safety and tolerability of Nd-YAG laser and TCA 20% in treatment of KP: adverse events
timeFrame: 4 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Alainy
Study officials:
affiliation: Cairo University
name: Akmal Saad, professor
role: PRINCIPAL_INVESTIGATOR
References:
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.