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