An observer blind, parallel group, randomised multicentre study to compare the safety and efficacy of a new formulation of topical clindamycin phosphate in patients with mild to moderate acne

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN72179764

Enrollment

270

Registered

2005-10-06

Start date

1999-07-19

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Mild to moderate acne vulgaris. Skin and Connective Tissue Diseases Acne

Interventions

Zindaclin® 1% Gel (twice a day [bd] & once a day [od]) and Dalacin-T® Topical Lotion (bd).

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Consenting patients of either sex, between 12 and 40 years of age, with mild to moderate inflammatory acne with a grade ranging from 2.0 to 7.0 (The Leeds Revised Acne Grading System, 1998).

Exclusion criteria

Exclusion criteria: 1. Patients with significant nodulocystic acne 2. Use of systemic topical antibiotics within 4 weeks prior to the start of treatment 3. Concomitant medication which may interfere with study evaluation

Design outcomes

Secondary

Measure	Time frame
1. The change in acne grade (The Leeds Revised Acne Grading System, 1998) from the baseline visit to the end of treatment 2. The change in number of total comedones, open comedones, closed comedomes, pustules 3. Mean change in total lesion count 4. Patient?s global assessment 5. Investigator?s global assessment	—

Primary

Measure	Time frame
The change in facial inflammatory lesion count from baseline visit to the end of treatment (week 16).	—

Countries

United Kingdom

Outcome results

None listed

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