Treatment of acne with dapsone gel plus oral isotretinoin

Comparison of 5% dapsone gel plus oral isotretinoin with oral isotretinoin alone in young patients with moderate to severe facial acne

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT2014011015509N1

Enrollment

Registered

2014-04-07

Start date

2013-01-18

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: Topical 5% dapsone gel was applied on the face twice daily for 8 weeks with Isotretinoin (Roaccutan) 20 mg daily.Mode of Use and application in the study: apply twice a day, every da

Methylparaben

Sodium Hydroxide

and Purified Water.treatment period was 8 weeks and total follow up period was 12 weeks. Intervention 2: Vehicle neutral gel was applied on the face twice daily for 8 weeks with Isotretinoin (Roaccuta

Treatment - Drugs

Topical 5% dapsone gel was applied on the face twice daily for 8 weeks with Isotretinoin (Roaccutan) 20 mg daily.Mode of Use and application in the study: apply twice a day, every day, for 8 weeks .

and Purified Water.treatment period was 8 weeks and total follow up period was 12 weeks.

Vehicle neutral gel was applied on the face twice daily for 8 weeks with Isotretinoin (Roaccutan) 20 mg daily.Mode of Use and application in the study: apply twice a day, every day, for 8 weeks .The

Eligibility

Sex/Gender

All

Age

18 Years to 25 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: age between 18 and 25 years old; moderate to severe facial acne; absence of contraindications to treatment with tablets of isotretinoin and 5% dapsone gel. Exclusion criteria: acne secondary to other problems; pregnancy or intention to become pregnant; breastfeeding; another dermatological disease of the face; G6PD deficiency; and known hypersensitivity to dapsone or isotretinoin.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Acne vulgaris lesions. Timepoint: Baseline, weeks 4, weeks 8, weeks 12. Method of measurement: Total Acne lesion Count( TLC.) and The Global Acne Assessment Score for each patient.	—

Secondary

Measure	Time frame
Side effects of drug. Timepoint: Every 4 weeks. Method of measurement: Clinical evaluation-laboratory test.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Mehrdad Rakhshanpour

Isfahan University of Medical Sciences

m_rakhshan_md@med.mui.ac.ir+98 31 1458 8136

Outcome results

None listed

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