UnknownPhase 3

Evaluating the Efficacy and Safety of Cleanser, Serum, and Sunscreen Products for Facial Redness.

20 participantsStarted 2023-08-11

Plain-language summary

The primary objective of this study is to assess the efficacy and safety of combination therapy of a Barrier Renew Cleanser, Barrier Renew PM Moisturizer, and mineral sunscreen in the treatment of redness.

Who can participate

Age range18 Years – 60 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Mild to moderate confluent facial redness or blotchy redness
✓. Mild to moderate score (1-6) for tactile roughness or dryness.
✓. A female is considered of childbearing potential unless she is postmenopausal, without a uterus and/or both ovaries, or has had a bilateral tubal ligation.
✓. Acceptable methods of birth control are: oral contraceptives, contraceptive patches/rings/implants, Implanon®, Depo-Provera®, double-barrier methods (e.g., condoms and spermicide), abstinence, and/or vasectomy of partner with a documented second acceptable method of birth control, should the subject become sexually active.

Exclusion criteria

✕. Retinoids and other vitamin A derivatives within 1 month
✕. Exfoliating and/or keratolytic products including alpha- or beta-hydroxy acids within 2 weeks
✕. Systemic retinoids within 6 months
✕. Systemic tetracycline class antibiotics within 2 months
✕. Systemic macrolide antibiotics within 4 weeks
✕. Initiation of change in hormonal therapy within 3 months

What they're measuring

Clinician Evaluator assessment of change of improvement using the expert grading scale for Redness

Timeframe: Baseline, Day 14, Day 30, Day 60

Clinician Evaluator assessment of change of improvement using the expert grading scale for Dryness/Scaling/Roughness

Timeframe: Baseline, Day 14, Day 30, Day 60

Clinician Evaluator assessment of change of improvement using the expert grading scale for Luminosity

Timeframe: Baseline, Day 14, Day 30, Day 60

Trial details

NCT IDNCT05961579

SponsorGoldman, Butterwick, Fitzpatrick and Groff

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-11-01

Contact for this trial

Andrea Pacheco

858-657-1004 apacheco@clderm.com

View on ClinicalTrials.gov More Redness trials

Who can participate

Age range18 Years – 60 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Mild to moderate confluent facial redness or blotchy redness
✓. Mild to moderate score (1-6) for tactile roughness or dryness.
✓. A female is considered of childbearing potential unless she is postmenopausal, without a uterus and/or both ovaries, or has had a bilateral tubal ligation.
✓. Acceptable methods of birth control are: oral contraceptives, contraceptive patches/rings/implants, Implanon®, Depo-Provera®, double-barrier methods (e.g., condoms and spermicide), abstinence, and/or vasectomy of partner with a documented second acceptable method of birth control, should the subject become sexually active.

Exclusion criteria

✕. Retinoids and other vitamin A derivatives within 1 month
✕. Exfoliating and/or keratolytic products including alpha- or beta-hydroxy acids within 2 weeks
✕. Systemic retinoids within 6 months
✕. Systemic tetracycline class antibiotics within 2 months
✕. Systemic macrolide antibiotics within 4 weeks
✕. Initiation of change in hormonal therapy within 3 months

What they're measuring

Clinician Evaluator assessment of change of improvement using the expert grading scale for Redness

Timeframe: Baseline, Day 14, Day 30, Day 60

Clinician Evaluator assessment of change of improvement using the expert grading scale for Dryness/Scaling/Roughness

Timeframe: Baseline, Day 14, Day 30, Day 60

Clinician Evaluator assessment of change of improvement using the expert grading scale for Luminosity

Timeframe: Baseline, Day 14, Day 30, Day 60