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

NCT ID: NCT04893304

Last Updated: 2021-05-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-30
• Study Completion Date: 2022-04-30

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.

Detailed Description

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 the following:

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

comparing both types of laser

Group Type: OTHER

co2 laser

Intervention Type: DEVICE

types of laser

Interventions

co2 laser

types of laser

Intervention Type: DEVICE

Other Intervention Names

NdYAG laser

Eligibility Criteria

Inclusion Criteria

1. age more than 18 years old

2. both genders

3. skin type III to V

4. controlled diabetus

Exclusion Criteria

1. pregnancy and lactation

2. scarring

3. active skin infections

4. endocrinal disorders

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Aya Mohamed Fahim

Principale investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

LAS123

Identifier Type: -

Identifier Source: org_study_id