Azathioprine combined with narrowband UVB 311 nm phototherapy for adults with atopic dermatitis

ISRCTN	ISRCTN22115905
DOI	https://doi.org/10.1186/ISRCTN22115905
Sponsor	Sechenov First Moscow State Medical University (Sechenov University)
Funder	I.M. Sechenov First Moscow State Medical University

Submission date: 02/10/2026
Registration date: 06/10/2026
Last edited: 06/10/2026

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Skin and Connective Tissue Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Nikolay Kochergin
Principal investigator, Public, Scientific

Department and Clinic of Skin and Venereal Diseases named after V.A. Rakhmanov, Sechenov First Moscow State Medical University, 4 Bolshaya Pirogovskaya st., bldg. 1
Moscow
119435
Russian Federation

Phone	+79161716929
Email	nkocha@yandex.ru

Dr Yingyu Ding
Principal investigator

Department and Clinic of Skin and Venereal Diseases named after V.A. Rakhmanov, Sechenov First Moscow State Medical University, 4 Bolshaya Pirogovskaya st., bldg. 1
Moscow
119435
Russian Federation

Phone	+79999836930
Email	1418973439zhengzheng@gmail.com

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Open (masking not used)
Control	Active
Assignment	Parallel
Purpose	Treatment
Scientific title	Efficacy and safety of combined azathioprine and narrowband UVB 311 nm therapy for atopic dermatitis
Study objectives	To evaluate the efficacy and safety of azathioprine plus narrowband UVB 311 nm phototherapy compared with narrowband UVB 311 nm phototherapy alone in adults with moderate-to-severe atopic dermatitis.
Ethics approval(s)	Approved 07/11/2024, Local Ethics Committee of Sechenov First Moscow State Medical University (Sechenov University) (1 Abrikosovsky Lane, building 1, moscow, 119435, Russian Federation; +7 (495) 622-97-06; lec_diss@staff.sechenov.ru), ref: 27-24
Health condition(s) or problem(s) studied	Atopic dermatitis
Intervention	Participants were randomized 1:1 into two parallel groups. The combination group received azathioprine 100 mg/day for 4 weeks together with narrowband UVB 311 nm phototherapy three times weekly. The control group received narrowband UVB 311 nm phototherapy three times weekly. NB-UVB was administered using a Waldmann 7001 device. The initial dose was 50–70% of the minimal erythema dose and was adjusted according to skin phototype and erythema response. Topical treatment was individualized according to clinical guidelines. Prohibited therapies were discontinued before enrollment according to a predefined washout period.
Intervention type	Drug/Device
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Azathioprine, narrowband UVB 311 nm phototherapy (Waldmann 7001)
Primary outcome measure(s)	Atopic dermatitis severity measured using the Scoring Atopic Dermatitis (SCORAD) index at baseline and 4 weeks
Key secondary outcome measure(s)
Completion date	09/07/2026

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	18 Years
Upper age limit	70 Years
Sex	All
Target sample size at registration	70
Total final enrolment	60
Key inclusion criteria	Adults aged 18–70 years Moderate-to-severe atopic dermatitis refractory to previous therapy, diagnosed according to the Hanifin and Rajka criteria, and disease severity was assessed using the SCORAD index and Investigator’s Global Assessment (IGA) Provided written informed consent
Key exclusion criteria	1. Autoimmune or malignant diseases 2. Pregnancy or lactation 3. Photodermatosis 4. Refusal or withdrawal of consent 5. Active infection 6. Severe chronic comorbidities 7. Use of concomitant treatments affecting study outcomes 8. Use of photosensitizing medications 9. Melanoma or non-melanoma skin cancer 10. Severe hepatic or renal impairment 11. Severe anemia, leukopenia, or thrombocytopenia 12. TPMT deficiency 13. Severe treatment-related adverse events, including hepatotoxicity, myelosuppression, and phototoxicity
Date of first enrolment	11/11/2024
Date of final enrolment	09/01/2026

Locations

Countries of recruitment

Russian Federation

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to share	No

Editorial Notes

05/10/2026: Study’s existence confirmed by the Local Ethics Committee of Sechenov First Moscow State Medical University (Sechenov University), Russia.