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A study to compare efficacy and tolerability of Oral Azithromycin versus Oral Doxycycline with topical Clindamycin in subjects with moderate to severe Acne Vulgaris

A prospective, randomised, open label, parallel group, comparative study of efficacy and tolerability of Oral Azithromycin versus Oral Doxycycline with topical Clindamycin in subjects with grade 2 and grade 3 Acne Vulgaris

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/05/013916
Enrollment
60
Registered
2018-05-16
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- ACNE VULGARIS GRADE 2 AND GRADE 3 Health Condition 2: L989- Disorder of the skin and subcutaneous tissue, unspecified

Interventions

Intervention1: Tab Azithromycin and topical Clindamycin: Tab Azithromycin 500mg OD 3 times a week for 8 weeks and topical Clindamycin 1% every night for 8 weeks Control Intervention1: Tab Doxycycline

Sponsors

Dr Apoorva
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Willingness to give written informed consent and availability for regular followup. Subjects with Acne Vulgaris of grade 2 and 3 as per the investigators global assessment scale. Subjects must be willing to refrain from using all other topical Acne medications or antibiotics during the 8 week treatment period.

Exclusion criteria

Exclusion criteria: Subjects with severe acne, nodulocystic lesions, acne conglobate, acne fulminans, acne rosacea, secondary(drug induced) acne.ion ingestion. Subjects with a history of hypersensitivity or allergy to any study medication ingredients. Subjects who have participated in any investigational drug study within 30 days prior to baseline will be excluded from participation. Female subjects who are pregnant,lactating or planning to become pregnant during study participation.

Design outcomes

Primary

MeasureTime frame
To assess and compare the efficacy and tolerability of oral Azithromycin and oral Doxycycline in subjects with grade 2 and 3 acne vulgarisTimepoint: 8 weeks—

Secondary

MeasureTime frame
Quality of life will be assessed using DLQI scoreTimepoint: 8 weeks—

Countries

India

Contacts

Public ContactDr APOORVA

KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCES, BANGALORE affiliated under RGUHS

drgirish_k@rediffmail.com9980911060

Outcome results

None listed

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