A PHOTOTRACKING STUDY DOCUMENTING THE CLINICAL … · 2020-07-21 · at least 10 inflammatory acne...
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A PHOTOTRACKING STUDY DOCUMENTING THE CLINICAL USEFULNESS OF A 3-STEP ACNE SYSTEM CONTAINING SOLUBILIZED 5% BENZOYL PEROXIDE LOTION Suzanne Bruce, MD Private practice, Houston, Texas INTRODUCTION Benzoyl peroxide (BPO) has poor solubility and tends to aggregate into clusters, which can impair its bioavailability. Furthermore, in some commercial formulations, the diameters of the BPO clusters may exceed the diameters of the hair follicles— hindering the passage of BPO into the follicles. A novel solubilized 5% BPO formulation has been developed that has been designed to ensure the BPO remains in solution, thereby offering the potential for greater BPO bioavailability and greater follicular penetration of BPO. The solubilized 5% BPO formulation is available as part of a 3-step acne system for normal to dry skin (where it is formulated as a lotion) or for normal to oily skin (where it is formulated as a gel). 1 The gel formulation is also available as a stand-alone product. 2 The 3-step acne system for normal to dry skin has previously been compared with a combination 5% BPO/clindamycin product in an investigator-blind randomized trial. The results from this trial showed that the (antibiotic-free) acne system resulted in comparable reductions in non-inflammatory and inflammatory lesion counts to the BPO/clindamycin product. 3 The 3-step acne system for normal to dry skin has now been further evaluated in a photographic tracking study in order to document photographically the degree and speed of clinical improvement attainable with the treatment. METHODS • Patients were eligible to enroll in this phototracking study if they had at least 25 acne lesions, including at least 10 inflammatory acne lesions. • All patients treated themselves for 8 weeks using the 3-step acne system for normal to dry skin, which comprises a: – Proprietary gentle cream cleanser – Solubilized 5% BPO lotion – Therapeutic moisturizer containing 20% glycerin and 1% dimethicone. • Patients were instructed to: – Wash their face twice daily with the cream cleanser and allow 10 minutes for the skin to dry completely CONCLUSIONS The 3-step acne system for normal to dry skin is an effective and well tolerated antibiotic-free treatment for acne, resulting in high levels of patient satisfaction. REFERENCES 1. CLENZIderm M.D. - Product Detail. OMP, Inc. web site. http://www.obagi.com/article/forpatients/ obagiclenzidermmd/products/products. html. Accessed December 1, 2008. 2. Introducing SoluCLENZ Rx Gel TM . OMP, Inc. web site. http://www.obagi.com/article/forpatients/ obagisoluclenzrx/soluclenz.html. Accessed December 2, 2008. 3. Green L. Efficacy and tolerability of a 3-step acne system containing a novel solubilized benzoyl peroxide lotion for normal to dry skin versus a benzoyl peroxide/clindamycin combination product: an investigator-blind, randomized, parallel-group study. Poster #110 presented at the American Academy of Dermatology 66th Annual Meeting, February 1-5, 2008, San Antonio, TX. http://www.obagi.com/documents/ CLZ002%20Poster%20FINAL.pdf. OMP, Inc. web site. Accessed December 5, 2008. DISCLOSURE Supported by OMP, Inc. – Apply one pump of the solubilized 5% BPO lotion once daily and allow the lotion to absorb into the skin completely – Apply the therapeutic moisturizer as needed. • If going outside, patients were requested to also apply a sunscreen. RESULTS Patients • A total of 10 patients (7 females, 3 males) were evaluated. • The patients were a mean of 19 years old (range, 12-28 years) and had Fitzpatrick skin types I-IV (10% I, 20% II, 50% III, 20% IV). • The appearance of the skin was considered to be normal (rather than dry) in all patients. • Four patients were considered to have sensitive skin. Efficacy • Photographic documentation of the clinical improvements attained with the 3-step acne system are shown in Figure 1. • At the end of the study: – 9 of 10 patients showed a reduction in non- inflammatory lesion count (median 52% reduction) – 9 of 10 patients showed a reduction in inflammatory lesion count (median 63% reduction). Tolerability • At the end of the study, the overall acceptance of the tolerability of treatment was rated as: – Excellent in 6 patients – Good in 3 patients – Fair in 1 patient. Patient satisfaction • Patients rated their satisfaction with the treatment regimen as: – Very satisfied in 5 patients – Satisfied in 4 patients – Dissatisfied in 1 patient (who was thought to develop contact dermatitis). Figure 1. Clinical improvement attained with the 3-step acne system. Baseline Week 2 Week 4 Baseline Week 2 Baseline Week 4 Baseline Week 2
Transcript of A PHOTOTRACKING STUDY DOCUMENTING THE CLINICAL … · 2020-07-21 · at least 10 inflammatory acne...
A PHOTOTRACKING STUDY DOCUMENTING THE CLINICAL USEFULNESS OF A 3-STEP ACNE SYSTEM CONTAINING SOLUBILIZED 5% BENZOYL PEROXIDE LOTION
Suzanne Bruce, MD Private practice, Houston, Texas
INTRODUCTION
Benzoyl peroxide (BPO) has poor solubility and tendsto aggregate into clusters, which can impair itsbioavailability. Furthermore, in some commercialformulations, the diameters of the BPO clusters mayexceed the diameters of the hair follicles—hindering thepassage of BPO into the follicles. A novel solubilized5% BPO formulation has been developed that has beendesigned to ensure the BPO remains in solution, therebyoffering the potential for greater BPO bioavailability andgreater follicular penetration of BPO. The solubilized5% BPO formulation is available as part of a 3-step acnesystem for normal to dry skin (where it is formulated asa lotion) or for normal to oily skin (where it is formulatedas a gel).1 The gel formulation is also available as astand-alone product.2
The 3-step acne system for normal to dry skin haspreviously been compared with a combination5% BPO/clindamycin product in an investigator-blindrandomized trial. The results from this trial showed thatthe (antibiotic-free) acne system resulted in comparablereductions in non-inflammatory and inflammatory lesioncounts to the BPO/clindamycin product.3 The 3-step acnesystem for normal to dry skin has now been furtherevaluated in a photographic tracking study in order todocument photographically the degree and speed ofclinical improvement attainable with the treatment.
METHODS
• Patients were eligible to enroll in this phototrackingstudy if they had at least 25 acne lesions, includingat least 10 inflammatory acne lesions.
• All patients treated themselves for 8 weeks using the3-step acne system for normal to dry skin, whichcomprises a:
– Proprietary gentle cream cleanser
– Solubilized 5% BPO lotion
– Therapeutic moisturizer containing 20% glycerinand 1% dimethicone.
• Patients were instructed to:
– Wash their face twice daily with the cream cleanserand allow 10 minutes for the skin to dry completely
CONCLUSIONS
The 3-step acne system for normal to dryskin is an effective and well toleratedantibiotic-free treatment for acne, resulting inhigh levels of patient satisfaction.
REFERENCES
1. CLENZIderm M.D. - Product Detail. OMP,Inc. web site.http://www.obagi.com/article/forpatients/obagiclenzidermmd/products/products.html. Accessed December 1, 2008.
2. Introducing SoluCLENZ Rx GelTM. OMP,Inc. web site.http://www.obagi.com/article/forpatients/obagisoluclenzrx/soluclenz.html. AccessedDecember 2, 2008.
3. Green L. Efficacy and tolerability of a3-step acne system containing a novelsolubilized benzoyl peroxide lotion fornormal to dry skin versus a benzoylperoxide/clindamycin combinationproduct: an investigator-blind,randomized, parallel-group study.Poster #110 presented at the AmericanAcademy of Dermatology 66th AnnualMeeting, February 1-5, 2008, San Antonio,TX. http://www.obagi.com/documents/CLZ002%20Poster%20FINAL.pdf. OMP,Inc. web site. Accessed December 5, 2008.
DISCLOSURE
Supported by OMP, Inc.
– Apply one pump of the solubilized 5% BPO lotiononce daily and allow the lotion to absorb into theskin completely
– Apply the therapeutic moisturizer as needed.
• If going outside, patients were requested to also applya sunscreen.
RESULTS
Patients
• A total of 10 patients (7 females, 3 males) wereevaluated.
• The patients were a mean of 19 years old (range,12-28 years) and had Fitzpatrick skin types I-IV(10% I, 20% II, 50% III, 20% IV).
• The appearance of the skin was considered to benormal (rather than dry) in all patients.
• Four patients were considered to have sensitive skin.
Efficacy
• Photographic documentation of the clinicalimprovements attained with the 3-step acne systemare shown in Figure 1.
• At the end of the study:
– 9 of 10 patients showed a reduction in non-inflammatory lesion count (median 52% reduction)
– 9 of 10 patients showed a reduction in inflammatorylesion count (median 63% reduction).
Tolerability
• At the end of the study, the overall acceptance of thetolerability of treatment was rated as:
– Excellent in 6 patients
– Good in 3 patients
– Fair in 1 patient.
Patient satisfaction
• Patients rated their satisfaction with the treatmentregimen as:
– Very satisfied in 5 patients
– Satisfied in 4 patients
– Dissatisfied in 1 patient (who was thought to developcontact dermatitis).
Figure 1. Clinical improvement attained with the 3-step acne system.
Baseline Week 2 Week 4 Baseline Week 2
Baseline Week 4Baseline Week 2
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