Evaluating efficacy of combination therapy with niosomal benzoyl peroxide and clindamycin

Comparing efficacy of combination therapy with niosomal benzoyl peroxide 1% - clindamycin 1% versus niosomal Clindamycin1% in acne vulgaris: A randomized clinical trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20170806035524N5

Enrollment

100

Registered

2018-08-15

Start date

2018-06-22

Completion date

Unknown

Last updated

2018-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acne vulgaris. acne vulgaris

Interventions

Intervention 1: Intervention group: niosomal combination of BPO 1% and CL 1% lotion. Route of administration: topical application, twice a day

duration of treatment: 12 weeks

manufacturing factory: Sorbitan monostearate (Span 60), polysorbate 60 (Tween 60) and cholesterol were purchased from Fluka, Switzerland. All other chemicals and soluble materials were prepared by Mer

Eligibility

Sex/Gender

All

Age

12 Years to 30 Years

Inclusion criteria

Inclusion criteria: patients with age between 12 to 30 years old. patients with mild to moderate acne vulgaris

Exclusion criteria

Exclusion criteria: pregnancy lactation history of allergy to clindamycin or BPO previous history of inflammatory bowel disease,colitis polycystic ovary syndrome, hirsutism, taking neuromuscular blockers or oral anti -acne drug since 6 months ago topical anti-acne drugs since 1 month ago

Design outcomes

Primary

Measure	Time frame
Acne lesion severity. Timepoint: At base line and 2,4, 8 and 12 weeks later. Method of measurement: Counting of acne lesions by physical examination, GAGS(Global Acne Grading System).;Number of counting of inflammatory and non-inflammatory acne lesions. Timepoint: At base line and 2,4, 8 and 12 weeks later. Method of measurement: counting of acne lesions by physical examination.;Quality of life. Timepoint: At base line and 2,4, 8 and 12 weeks later. Method of measurement: by Cardiff Acne Disability Index (CADI) questionnair.	—

Measure

Time frame

Acne lesion severity. Timepoint: At base line and 2,4, 8 and 12 weeks later. Method of measurement: Counting of acne lesions by physical examination, GAGS(Global Acne Grading System).;Number of counting of inflammatory and non-inflammatory acne lesions. Timepoint: At base line and 2,4, 8 and 12 weeks later. Method of measurement: counting of acne lesions by physical examination.;Quality of life. Timepoint: At base line and 2,4, 8 and 12 weeks later. Method of measurement: by Cardiff Acne Disability Index (CADI) questionnair.

—

Secondary

Measure	Time frame
Erythema. Timepoint: at base-line(before intervention) and at weeks 2, 4, 8,12. Method of measurement: by physical examinatin.;Scaling. Timepoint: at base-line(before intervention) and at weeks 2, 4, 8,12. Method of measurement: by physical examination and classification of the severity of adverse effects to mild, moderate and severe.;Pruritis. Timepoint: at base-line(before intervention) and at weeks 2, 4, 8,12. Method of measurement: by physical examination and classification of the severity of adverse effects to mild, moderate and severe.	—

Measure

Time frame

Erythema. Timepoint: at base-line(before intervention) and at weeks 2, 4, 8,12. Method of measurement: by physical examinatin.;Scaling. Timepoint: at base-line(before intervention) and at weeks 2, 4, 8,12. Method of measurement: by physical examination and classification of the severity of adverse effects to mild, moderate and severe.;Pruritis. Timepoint: at base-line(before intervention) and at weeks 2, 4, 8,12. Method of measurement: by physical examination and classification of the severity of adverse effects to mild, moderate and severe.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMahin Aflatoonian

Kerman University of Medical Sciences

maaflatoonian@gmail.com+98 34 3132 8328

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026