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

Brief Title

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

Official Title

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

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.
    


Study Type

Interventional


Primary Outcome

patient evaluation


Condition

Acanthosis Nigricans

Intervention

co2 laser

Study Arms / Comparison Groups

 1 group of 20 patients doing both types of lasers on 2 sites
Description:  comparing both types of laser

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

20

Start Date

May 30, 2021

Completion Date

April 30, 2022

Primary Completion Date

April 30, 2022

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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, , 



Administrative Informations


NCT ID

NCT04893304

Organization ID

LAS123


Responsible Party

Principal Investigator

Study Sponsor

Cairo University


Study Sponsor

, , 


Verification Date

May 2021