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Effectiveness of niosomal clindamycin solution in treatment of acne

Comparing thr efficacy of topical 1 % clindamycin phosphate and niosomal clindamycin phosphate 1% solusion in reduction of acne vulgaris lesions

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT2017080635524N1
Enrollment
100
Registered
2017-10-19
Start date
2015-03-20
Completion date
Unknown
Last updated
2018-02-22

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: Clindamycin phosphate niosomal solution1% twice daily. Intervention 2: Control group: 1% Clindamycin phosphate solution twice daily.
Treatment - Drugs
Intervention group: Clindamycin phosphate niosomal solution1% twice daily
Control group: 1% Clindamycin phosphate solution twice daily

Sponsors

Vice Chancellor for research of Kerman University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
12 Years to 30 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Mild to moderate acne vulgaris; Both male and female;age (12-30years); lack of treatment during the one month period before the study exclusion criteria: pregnancy; breast feeding; hypersensitivity to clindamycin; history of inflamatory bowel disease(IBD); history of neuromuscular junction blocker using; history of systemic retinoid using in the past 6 month; history of oral estrogen using in the past 3 month; history of topical retinoid and oral antibiotic using in the past 1 month; history of antimicrobial soap and comedogenic products using in the past 2 weeks; history of astringents and abrasive products using in the past 1 week; hirsutism; androgenetic alopecia; Polycystic ovarian syndrome.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Acne severity. Timepoint: Baseline, two weeks after intervention ,four weeks after intervention, eight weeks after intervention, twelve weeks after intervention. Method of measurement: Inflammatory and non-inflammatory lesions count, mild acne: most non-inflammatory lesions or less than 15 inflammatory lesions, moderate acne: 15 to 50 inflamatory lesions.;Acne grading. Timepoint: Baseline, two weeks after intervention ,four weeks after intervention, eight weeks after intervention, twelve weeks after intervention. Method of measurement: Global Acne Grading system: The face is divided into five parts, forehead(2 factor), right and left cheek(2 factor), nose(1 factor), chin(1 factor), no lesions = 0, comedones = 1, papules = 2, pustules = 3 and nodules = 4. The score for each area (Local score) is calculated using the formula: Local score = Factor × Grade (0-4). The global score is the sum of local scores.

Secondary

MeasureTime frame
Erythema. Timepoint: Baseline, two weeks after intervention ,four weeks after intervention, eight weeks after intervention, twelve weeks after intervention. Method of measurement: Inspection.;Pruritus. Timepoint: Baseline, two weeks after intervention ,four weeks after intervention, eight weeks after intervention, twelve weeks after intervention. Method of measurement: Questionnaire.;Scaling. Timepoint: Baseline, two weeks after intervention ,four weeks after intervention, eight weeks after intervention, twelve weeks after intervention. Method of measurement: Inspection.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHoda Badakhsh

Kerman University of Medical Sciences

hbadakhsh@yahoo.com+98 34 3325 7651

Outcome results

None listed

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