A clinical trial to study the effectiveness of minocycline 4% gel in mild to moderate facial acne

Randomized controlled trial comparing the efficacy of minocycline 4% gel versus benzoyl peroxide 2.5% gel in patients with mild to moderate facial acne, a split face study from eastern India

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/06/053579

Enrollment

Registered

2023-06-06

Start date

Unknown

Completion date

Unknown

Last updated

2023-06-26

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

Conditions

Health Condition 1: L700- Acne vulgaris

Interventions

Intervention1: Minocycline 4% gel: Each patientâ??s face will be split into exact two halves by vertical midline and benzoyl peroxide 2.5% gel will be applied on one half and minocycline 4% gel on the

Eligibility

Inclusion criteria

Inclusion criteria: Patients above 18 years of age having minimum of 10 facial lesions on each side of face (including both non-inflammatory and inflammatory acne) and have not received any systemic or topical acne treatment in last 4 weeks.

Exclusion criteria

Exclusion criteria: Patients with nodulo-cystic acne lesions. Pregnant and lactating patients. Patients with severe psychiatric illness. Patients with major systemic illness or severe co-morbidities. Patients on anti-coagulant or immunosuppressive therapy. Patients with history of allergic reaction to tetracycline group of drugs. Patients having history of systemic retinoid therapy in last 6 months. Patients with concomitant use of photosensitizing or neuromuscular blocking agents.

Design outcomes

Primary

Measure	Time frame
Number of acne lesions over each half of face is counted at baseline and then at every visitTimepoint: Patient is asked to follow up after 2 weeks, 4 weeks and 8 weeks.	—

Secondary

Measure	Time frame
Investigator Static Global Assessment score (ISGA) Grade 0 Normal clear skin with no evidence of acne vulgaris Grade 1 Rare non-inflammatory lesions present, with rare non-inflamed papules Grade 2 Some non-inflammatory lesions present with few inflammatory lesions (papules/pustules only, no nodulocystic lesions) Grade 3 Non-inflammatory lesions predominate with multiple inflammatory lesions evident, several to many comedones and papules/pustules, there may or may not be one small nodulocystic lesion Grade 4 Inflammatory lesions are more apparent, many comedones and papules/pustules, there may or may not be a few nodulocystic lesions Grade 5 Highly inflammatory lesions predominate, variable number of comedones, many papules/pustules and many nodulocystic lesionsTimepoint: Patient is asked to follow up after 2 weeks, 4 weeks and 8 weeks.	—

Measure

Time frame

Investigator Static Global Assessment score (ISGA) Grade 0 Normal clear skin with no evidence of acne vulgaris Grade 1 Rare non-inflammatory lesions present, with rare non-inflamed papules Grade 2 Some non-inflammatory lesions present with few inflammatory lesions (papules/pustules only, no nodulocystic lesions) Grade 3 Non-inflammatory lesions predominate with multiple inflammatory lesions evident, several to many comedones and papules/pustules, there may or may not be one small nodulocystic lesion Grade 4 Inflammatory lesions are more apparent, many comedones and papules/pustules, there may or may not be a few nodulocystic lesions Grade 5 Highly inflammatory lesions predominate, variable number of comedones, many papules/pustules and many nodulocystic lesionsTimepoint: Patient is asked to follow up after 2 weeks, 4 weeks and 8 weeks.

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Countries

India

Contacts

Public ContactSaubhagya Chowdhury

IPGME&R and SSKM hospital

drsumitsen@gmail.com9433960150

Outcome results

None listed

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