20 completed. 10 Phase 1, 6 Phase 3, 5 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 10 | Completed 10 |
| Phase 3 | 6 | Completed 6 |
| Phase 2 | 5 | Completed 5 |
Follow berdazimer sodium: new trials by email Literature Review of berdazimer sodium trials Research Report on berdazimer sodium
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Phase 3 Molluscum Contagiosum Efficacy and Safety Study SB206 10.3% berdazimer, vehicle gel - Molluscum Contagiosum | Phase 3 | Completed | Novan, Inc. | 891 | 2020-09-01 | 2023-01-26 |
| A Phase 3 Efficacy & Safety of SB206 & Vehicle Gel for the Treatment of MC SB206 12%, Placebo - Molluscum Contagiosum | Phase 3 | Completed | Novan, Inc. | 355 | 2019-06-13 | 2023-03-23 |
| A Phase 3 Randomized Parallel Group Study Comparing the Efficacy & Safety of SB206 & Vehicle Gel in the Treatment of MC (B-SIMPLE1) SB206 12%, Placebo - Molluscum Contagiosum | Phase 3 | Completed | Novan, Inc. | 352 | 2019-06-03 | 2022-12-27 |
| A Study to Evaluate the Safety and Efficacy of SB206 in Subjects With Molluscum Contagiosum SB206 4%, SB206 8%, SB206 12% - Molluscum Contagiosum | Phase 2 | Completed | Novan, Inc. | 256 | 2018-01-24 | 2023-05-06 |
| A Phase 1b Study Assessing the PK, PD, Safety & Tolerability of SB414 in Atopic Dermatitis SB414 2%, SB414 6%, Vehicle - Atopic Dermatitis | Phase 1 | Completed | Novan, Inc. | 48 | 2017-11-13 | 2018-09-07 |
| A Study Assessing the PK, PD, Safety, and Tolerability of SB414 in Psoriasis SB414 6%, Vehicle - Psoriasis | Phase 1 | Completed | Novan, Inc. | 36 | 2017-10-13 | 2018-03-27 |
| Pharmacokinetics of Topical SB204 in Adolescents With Acne Vulgaris SB204 4% - Acne Vulgaris | Phase 1 | Completed | Novan, Inc. | 18 | 2016-06-07 | 2018-10-12 |
| P3 Long Term Safety Study of Once Daily SB204 in Acne SB204 4% - Acne Vulgaris | Phase 3 | Completed | Novan, Inc. | 601 | 2016-05-12 | 2023-05-12 |
| P3 Study in Acne Comparing Once Daily SB204 and Vehicle SB204 4%, Vehicle Gel - Acne Vulgaris | Phase 3 | Completed | Novan, Inc. | 1307 | 2016-02-22 | 2023-07-24 |
| P3 Study Comparing Once Daily SB204 and Vehicle Gel in Acne SB204 4%, Vehicle Gel - Acne Vulgaris | Phase 3 | Completed | Novan, Inc. | 1330 | 2016-02-19 | 2023-07-24 |
| A Thorough ECG Study in Subjects With Acne Vulgaris Treated With SB204 SB204 4%, SB204 8% or 12%, Vehicle - Acne Vulgaris | Phase 1 | Completed | Novan, Inc. | 56 | 2015-10-01 | 2018-11-19 |
| Topical NVN1000 for the Treatment of External Genital and Perianal Warts NVN1000 8% Gel, NVN1000 16%, Vehicle - Genital Warts, Perianal Warts | Phase 2 | Completed | Novan, Inc. | 108 | 2015-06-12 | 2023-04-06 |
| P2 Multi-center Study of SB204 Gel in the Treatment of Acne Vulgaris SB204 2%, SB204 4%, Vehicle Gel - Acne Vulgaris | Phase 2 | Completed | Novan, Inc. | 213 | 2014-11-01 | 2023-05-31 |
| A Phase 1 Study Assessing Local Cutaneous Effects of SB204 SB204 - Acne Vulgaris | Phase 1 | Completed | Novan, Inc. | 8 | 2014-09-01 | 2018-11-19 |
| A 2 Period Cross-over Pharmacokinetic Study of SB204 in Acne Vulgaris SB204, Vehicle Gel - Acne Vulgaris | Phase 1 | Completed | Novan, Inc. | 18 | 2014-06-01 | 2015-04-03 |
| A Phase 2, 3 Arm Study of NVN1000 Gel and Vehicle Gel in Subjects With Acne NVN1000 1% Gel, NVN1000 4% Gel, Vehicle Gel - Acne Vulgaris | Phase 2 | Completed | Novan, Inc. | 153 | 2013-04-01 | 2018-11-19 |
| A Phase 1 Study Evaluating Safety and Tolerability of NVN1000 Gel NVN1000 4% Gel, Vehicle Gel - Acne Vulgaris | Phase 1 | Completed | Novan, Inc. | 30 | 2013-04-01 | 2018-11-19 |
| A Phase 1, 3 Day Study of Safety and Tolerability of NVN1000 Topical Gel in Healthy Volunteers Topical Gel Vehicle, 8% NVN1000 Topical Gel, 8% NVN1000 Topical Gel and moisturizer - Acne Vulgaris | Phase 1 | Completed | Novan, Inc. | 15 | 2012-11-01 | 2019-09-10 |
| Cutaneous Tolerability and Safety of NVN1000 Topical Gel in Healthy Volunteers 2% NVN1000 Topical Gel, 4% NVN1000 Topical Gel, 8% NVN1000 Topical Gel - Acne Vulgaris | Phase 1 | Completed | Novan, Inc. | 60 | 2012-09-01 | 2020-01-30 |
| Study of NVN1000 Topical Gel and Topical Gel Vehicle in the Treatment of Moderate to Severe Acne Vulgaris NVN1000, Vehicle - Acne Vulgaris, Acne | Phase 1 / Phase 2 | Completed | Novan, Inc. | 70 | 2011-07-01 | 2018-11-19 |
Acne Vulgaris (13) · Molluscum Contagiosum (4) · Condylomata Acuminata (1) · Dermatitis, Atopic (1) · Psoriasis (1)
Novan, Inc. (20)
United States (18) · Dominican Republic (2) · Honduras (1) · Panama (1)
Joyce Rico, MD (6) · Tomoko Maeda-Chubachi, MD (2) · Adelaide Hebert, MD (1) · Amy Paller, MD (1) · Carlos Sanabria, MD (1) · Daisy Blanco, MD (1) · James J Leyden (1) · James J Leyden, MD (1) · Joyce Rico (1) · M J Rico, MD (1) · M. Joyce Rico, MD (1) · Stuart Lessin, MD (1) · Tomoko Maeda Chubachi, MD PhD (1) · Tomoko Maeda-Chubachi (1)
PMID 34909721, PMID 27672413, PMID 32428543, PMID 35830173, PMID 36287306