Evaluation of the Efficacy, Safety, Satisfaction, Tolerability, and Durability of Q-Switched Nd:YAG 1064 nm Laser in Combination with Erbium:YAG 2940 nm Laser and Each Laser Alone in the Treatment of Macular Amyloidosis in Patients Undergoing Modified Klignman’s Formula Therapy: A Randomized, Four-Arm, Split-Face, Assessor-Blinded Clinical Trial
To evaluate the efficacy of fractional Q-switched Nd:YAG 1064 nm laser compared to Erbium:YAG laser and to compare each monotherapy with their combined use in the treatment of macular amyloidosis.
Design
Fifteen patients were enrolled, with affected areas divided into four treatment zones:
Fractional QS Nd:YAG
Er:YAG
Combined lasers
Control (topical only)
Blinding: Double-blind (patients & assessors unaware of treatment allocation)
Settings and conduct
The combined laser intervention was performed on hyperpigmented lesions at Rasool Akram Medical Center under double-blind conditions, with both participants and evaluators blinded to treatment allocation across study zones.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Female patients aged 18–50 years with a confirmed diagnosis of macular amyloidosis and no history of laser treatment for the condition within the past three months. Exclusion Criteria: Development of hypersensitivity or any treatment-related adverse effects that would prevent continuation of therapy.
Pregnancy and Presence of severe underlying systemic diseases
Intervention groups
All enrolled patients will receive topical application of the modified Kligman's formula, to be applied uniformly to all affected and hyperpigmented areas. Following this baseline treatment, the hyperpigmented lesions of each patient will be divided into four distinct zones, with each zone receiving one of the following interventions:
Zone 1: Fractional Q-switched Nd:YAG laser treatment Zone 2: Erbium:YAG laser treatment Zone 3: Combined fractional Q-switched Nd:YAG + Erbium:YAG laser therapy Zone 4 (Control): Topical Kligman's formula only
Main outcome variables
Resolution of refractory hyperpigmentation. Improvement in patients' quality of life. Identification of optimal treatment for resistant pigmentation disorders
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231104059946N1
Registration date:2025-05-08, 1404/02/18
Registration timing:retrospective
Last update:2025-05-08, 1404/02/18
Update count:1
Registration date
2025-05-08, 1404/02/18
Registrant information
Name
paria jafary
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3254 7873
Email address
p.jafary74@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-15, 1402/11/26
Expected recruitment end date
2025-02-14, 1403/11/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Efficacy, Safety, Satisfaction, Tolerability, and Durability of Q-Switched Nd:YAG 1064 nm Laser in Combination with Erbium:YAG 2940 nm Laser and Each Laser Alone in the Treatment of Macular Amyloidosis in Patients Undergoing Modified Klignman’s Formula Therapy: A Randomized, Four-Arm, Split-Face, Assessor-Blinded Clinical Trial
Public title
Combined Laser Modalities for the Treatment of Macular Amyloidosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Female patients aged 18 to 50 years
Confirmed diagnosis of macular amyloidosis
No prior laser treatment for the condition within the last three months
Absence of significant underlying medical conditions
Patient compliance with treatment protocols and ability to attend all therapy sessions
Non-pregnant status and no plans for pregnancy within the next six months
No active infections
No hypersensitivity to retinoids or their derivatives
No active rheumatologic diseases (e.g., lupus)
Exclusion criteria:
Development of hypersensitivity or any adverse reaction to the treatment interventions that would preclude continuation of therapy
Pregnancy or plans for pregnancy within the next 6 months
Active infection
Active lupus or other active rheumatologic diseases
Hypersensitivity to retinoids or their derivatives
Immunodeficiency disorders
Patient unwillingness to continue treatment
Age
From 18 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
15
More than 1 sample in each individual
Number of samples in each individual:
4
In this study, patients with extensive macular amyloidosis (involving the trunk and extremities) refractory to topical treatments were enrolled. All participants were initially prescribed a topical combination medication with modified Kligman’s formula (hydroquinone 4g + vitamin C 3g + retinol 3cc + in cold cream base up to 100g), to be applied uniformly to all affected areas. Subsequently, hyperpigmented lesions were divided into four distinct zones, each receiving one of the following interventions administered by the study operator: Fractional Q-switched laser (Zone 1), 1),Erbium:YAG laser (Zone 2), combined fractional Q-switched + Erbium:YAG lasers (Zone 3), and topical Kligman’s formula alone (Zone 4, control).
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Due to the significant differences between the mentioned therapeutic interventions, blinding of the patient and the treating physician was not feasible. Therefore, the study will be conducted in a single-blind manner. In other words, outcome assessments will be performed by an evaluator blinded to the type of intervention (a dermatologist unaware of which treatment was administered to specific areas of the patient’s skin), based on standardized photographs of the lesions taken at each session. Additionally, data analysis will be conducted by a blinded statistician
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
Unit 2, No. 13, Nik Roshfard St., Shadmehr St., Tehran
City
tehran
Province
Tehran
Postal code
1456744319
Approval date
2023-10-09, 1402/07/17
Ethics committee reference number
IR.IUMS.FMD.REC.1402.302
Health conditions studied
1
Description of health condition studied
Macular amyloidosis
ICD-10 code
E85.4
ICD-10 code description
Organ-limited amyloidosis
Primary outcomes
1
Description
hyperpigmentation improvement percentage
Timepoint
Assessments were conducted at three timepoints: (1) baseline, (2) pre-second session (3 weeks later), and (3) 4 weeks after the second intervention.