Papulopustular Rosacea Clinical Trial
Official title:
Randomized, Double-Blind, Cross-Over, Vehicle Controlled Evaluation of Topical Encapsulated Benzoyl Peroxide on the Skin Microbiome and Skin Biophysical Properties
Verified date | April 2023 |
Source | Sol-Gel Technologies, Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The overall objective of this study is to assess how the use of the drug may shift the skin microbiome and skin biophysical properties. Specifically, the study objectives were to assess the following: - How the drug affects the skin microbiome compared with vehicle when applied once daily for 8 weeks in subjects with papulopustular rosacea. - How the drug affects the skin physical properties compared with vehicle when applied once daily for 8 weeks in subjects with papulopustular rosacea.
Status | Completed |
Enrollment | 31 |
Est. completion date | July 15, 2021 |
Est. primary completion date | July 15, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Participants must sign an Institutional Review Board (IRB) approved written informed consent for this study. - Male and female 18 years of age and older. - Participants must have clinical diagnosis of moderate to severe rosacea. - Have a minimum total of 15 and a maximum of 70 total inflammatory lesions (papules and/or pustules) including those present on the nose. - Have 2 nodules or less. Exclusion Criteria: - Females, who are pregnant, breastfeeding, or planning a pregnancy within the period of their study participation or were found to have positive pregnancy test at Baseline or screening visits. - Presence of more than 2 facial nodules or any nodule greater than 1 centimeter (cm). - Current or past ocular rosacea (for example, conjunctivitis, blepharitis, or keratitis) of sufficient severity to require topical or systemic antibiotics. |
Country | Name | City | State |
---|---|---|---|
United States | Integrative Skin Science and Research (ISSR) | Sacramento | California |
Lead Sponsor | Collaborator |
---|---|
Sol-Gel Technologies, Ltd. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in skin microbiome diversity after 8-weeks of treatment compared to baseline | Facial microbiome sampling will be performed on-site by collecting follicular samples as well as utilizing facial swabs. | 8-weeks | |
Primary | Change in transepidermal water loss after 8-weeks of treatment compared to baseline. | transepidermal water loss in g/m2/h | 8-weeks | |
Primary | Change in stratum corneum hydration after 8-weeks of treatment compared to baseline. | stratum corneum water content (wt%) | 8-weeks | |
Primary | Change in sebum excretion rate after 8-weeks of treatment compared to baseline. | sebum production in µg/cm2 | 8-weeks | |
Primary | Change in colorimeter test after 8-weeks of treatment compared to baseline. | facial L*a*b* values | 8-weeks | |
Secondary | Change in skin microbiome diversity after 30 minutes, 1-week, 2-weeks and 4-weeks of treatment compared to baseline | Facial microbiome sampling will be performed on-site by collecting follicular samples as well as utilizing facial swabs. | 4-weeks | |
Secondary | Change in transepidermal water loss after 1-week, 2-weeks and 4-weeks of treatment compared to baseline. | transepidermal water loss in g/m2/h | 4-weeks | |
Secondary | Change in stratum corneum hydration after 1-week, 2-weeks and 4-weeks of treatment compared to baseline. | stratum corneum water content (wt%) | 4-weeks | |
Secondary | Change in sebum excretion rate after 1-week, 2-weeks and 4-weeks of treatment compared to baseline. | sebum production in µg/cm2 | 4-weeks | |
Secondary | Change in colorimeter test after 1-week, 2-weeks and 4-weeks of treatment compared to baseline. | facial L*a*b* values | 4-weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03276936 -
A Study to Evaluate the Long-Term Safety of Topical Administration of FMX103 in the Treatment of Moderate to Severe Papulopustular Rosacea
|
Phase 3 | |
Completed |
NCT02601963 -
Safety and Efficacy Study of a Topical Minocycline Foam in Patients With Papulopustular Rosacea
|
Phase 2 | |
Completed |
NCT02268474 -
Excel V 532 nm KTP Laser for Treatment of Erythematotelangiectatic Rosacea & Papulopustular Rosacea
|
N/A | |
Completed |
NCT01555463 -
Safety and Efficacy of Azelaic Acid Foam, 15 % in Papulopustular Rosacea
|
Phase 3 | |
Active, not recruiting |
NCT03667222 -
Topical Minocycline Gel for Inflammatory Lesions of Papulopustular Rosacea
|
Phase 2 | |
Terminated |
NCT03564145 -
A Long-Term Safety Study of S5G4T-1 in the Treatment of Papulopustular Rosacea
|
Phase 3 | |
Completed |
NCT05150587 -
Safety, Efficacy and Pharmacokinetics of Rifaximin in Patients With Moderate-to-severe Papulopustular Rosacea
|
Phase 2 | |
Completed |
NCT03263273 -
Study to Evaluate the Safety and Efficacy of Topical Minocycline Gel in Patients With Papulopustular Rosacea
|
Phase 2 | |
Completed |
NCT05343455 -
A Study to Assess the Safety, Efficacy and Tolerability of Oral DFD-29 Capsules for the Treatment of Rosacea (MVOR-2)
|
Phase 3 | |
Completed |
NCT01872715 -
Patient Centered Outcomes in Rosacea: An Exploratory Multi-media Analysis of the Patient Experience on Oracea
|
Phase 4 | |
Completed |
NCT01784133 -
A Twelve Week Safety and Efficacy Study in Rosacea
|
Phase 2 | |
Completed |
NCT05296629 -
A Randomized, Double-Blind Study to Assess the Safety, Efficacy and Tolerability of Oral DFD-29 Capsules for the Treatment of Rosacea.
|
Phase 3 | |
Completed |
NCT05838170 -
Study of TP-04 in Participants With Papulopustular Rosacea
|
Phase 2 | |
Recruiting |
NCT06013371 -
PDE4 Inhibition in Seborrheic Dermatitis and Papulopustular Rosacea
|
Phase 2 | |
Recruiting |
NCT03864978 -
Safety and Efficacy of Rifaximin in Patients With Papulopustular Rosacea and Positive Lactulose Breath Test
|
Phase 2 | |
Completed |
NCT03564119 -
A Study of S5G4T-1 in the Treatment of Papularpustular Rosacea
|
Phase 3 | |
Completed |
NCT03079531 -
Open Label Study to Assess the Effect of Secukinumab in Moderate to Severe Papulopustular Rosacea
|
Phase 1/Phase 2 | |
Completed |
NCT01045551 -
Open Label Pilot Study of Apremilast in Treatment of Rosacea
|
Phase 2 | |
Completed |
NCT03448939 -
A Study of S5G4T-1 in the Treatment of Papulopustular Rosacea
|
Phase 3 | |
Withdrawn |
NCT03883945 -
A Safety and Efficacy Study to Evaluate Rosacea
|
Phase 1/Phase 2 |