Study of the Effect of Fractional co2 Laser Versus Q Switched:NdYAG Laser in the Treatment of Acanthosis Nigricans

NCT04893304 | Unknown DMC

• 1 other identifier: LAS123
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

This prospective randomized comparative split study will be conducted at the outpatient clinic, Dermatology department, Faculty of Medicine, Cairo University and will include 20 patients with acanthosis nigricans in otherwise healthy individuals which will be recruited and assessed for eligibility for inclusion according to the above criteria.

• Evaluation: All patients will be subjected to: Pre-operative preparation:
• Informed written consent will be taken from every patient prior to the study.
• Detailed history taking including onset, course, duration of the disease and occupation (sun-exposed or not), predisposing factors, history of keloid tendency, associated diseases and previous treatments.
• Assessment of skin type, BMI, degree of AN, HbA1C, site of lesions in all patients and degree of improvement.
• Photography: will evaluate the clinical response to treatment for each patient Photos will be taken before starting the study, before every session, and two weeks after the last session.
• Melanin index (MI) will be measured using reflectance spectrophotometer in order to assess the degree of hyperpigmentation before starting the study and two weeks after the last session. Research Template 8 Final Version: April 2019
• Acanthosis Nigricans Area and Severity Index (ANASI) score (Zaki et al., 2018) will be done for all patients before starting the study and two weeks after the last session.
• Patient satisfaction score will be assessed before starting the study and two weeks after the last session.
• Patient evaluation (clinical percentage of improvement). Operation : One side of the affected area will be randomly assigned to fractional CO2 laser every four weeks for three months. The other side will be assigned to Q-switched Nd:YAG laser every four weeks for three months. Method of randomization: Using closed envelopes containing cards with fractional CO2 Rt and fractional CO2 Lt and the patient will draw one of them blindly. The assessment will be done by blinded investigator. Post-operative: Patients will be instructed to avoid sun exposure for one week after the session and regular use of sun block in between sessions.

Conditions

Acanthosis Nigricans

Outcome Measures

Primary Outcomes (1)

• patient evaluation

  Acanthosis nigricans area and severity index is scoring system used to assess patients before the session and after the session to assess finally the improvement

  3 months

Study Arms (1)

1 group of 20 patients doing both types of lasers on 2 sites

OTHER

comparing both types of laser

Device: co2 laser

Interventions

co2 laser DEVICE

types of laser

Also known as: NdYAG laser

1 group of 20 patients doing both types of lasers on 2 sites

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age more than 18 years old
• both genders
• skin type III to V
• controlled diabetus

You may not qualify if:

• pregnancy and lactation
• scarring
• active skin infections
• endocrinal disorders

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Acanthosis Nigricans

Interventions

Lasers, Gas

Condition Hierarchy (Ancestors)

Melanosis; Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principale investigator

Study Record Dates

• First Submitted: April 25, 2021
• First Posted: May 19, 2021
• Study Start: May 30, 2021
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: May 19, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: after finishing the paper and will be always be available
• Access Criteria: through the pubmed