Journal of the American Academy of Dermatology, 2014
Background: Vismodegib, a first-in-class Hedgehog pathway inhibitor, was US Food and Drug Adminis... more Background: Vismodegib, a first-in-class Hedgehog pathway inhibitor, was US Food and Drug Administration (FDA) approved for advanced basal cell carcinomas (BCCs) based on a single, nonrandomized, phase-II trial. Consequently, additional clinical data are critical to confirm the efficacy and safety of vismodegib. Objective: We sought to assess efficacy and safety of vismodegib, while providing early drug access to patients with advanced BCC and limited treatment options. Methods: This was an open-label, multicenter study in patients with advanced BCC inappropriate for radiotherapy or surgery. Patients received 150 mg vismodegib daily until disease progression or intolerable toxicity. Tumor response was assessed via Response Evaluation Criteria in Solid Tumors version 1.0. Results: A total of 119 patients with advanced BCC took vismodegib for a median of 5.5 months. Objective responses occurred in 46.4% of locally advanced BCC and 30.8% of patients with metastatic BCC. Response was negatively associated with prior systemic therapy in patients with locally advanced BCC (P = .002). Mean follow-up for safety was 6.5 months, with muscle spasms (70.6%), dysgeusia (70.6%), alopecia (58.0%), and diarrhea (25.2%) as the most common adverse events. Limitations: Abbreviated follow-up time because of study termination upon FDA approval was a limitation. Conclusion: This study provides important clinical data supporting the efficacy and safety of vismodegib. Larger studies are underway to assess predictors of response and long-term outcomes.
Products that may cause irritation are widely used to treat acne. Irritation has the potential to... more Products that may cause irritation are widely used to treat acne. Irritation has the potential to reduce treatment adherence. How patients manage irritation and dryness is not well characterized. To study self-reported irritation, its impact and coping mechanisms in patients who had been treated for acne with a clindamycin-5% benzoyl peroxide (BPO) product. An Internet-based survey of 200 subjects, aged 15-40 years who had used a clindamycin-5% BPO fixed combination product in the last six months on at least 50 percent of their face, at least five days per week. The majority of subjects (57%) had moderate acne, 28 percent had severe acne. Bothersome side effects of the clindamycin-5% BPO combination included dry skin (55%), flaky/peeling skin (45%), irritated skin (44%), itchy skin (39%) and redness (37%). As a result, subjects used the product only as a spot treatment (33%), only when breakouts seemed worse (28%), or less often than recommended (32%); stopped using from time to time (32%); switched to a different prescription medication and/or an over-the-counter acne product (28%); or stopped using altogether (10%). 41 percent of subjects reported using moisturizers to counteract dryness and redness. We queried patients concerning use of combination clindamycin/BPO products and not other products. Irritation to clindamycin-5% BPO is a common problem that reduces patients' use of the medication. Strategies to improve treatment include communication with patients on possible side effects, providing written instruction on how to manage irritation and dryness and consideration of alternative topical treatments and treatment regimens.
Journal of the American Academy of Dermatology, 2004
... preliminary findings from a 12-week dose-ranging trial☆. Diana M. Chen, MD: Affiliations. Abb... more ... preliminary findings from a 12-week dose-ranging trial☆. Diana M. Chen, MD: Affiliations. Abbott Laboratories, Abbott Park, IL, United States USA; Diana Chen, MD, is employed by Abbott Laboratories. ,; Kenneth Gordon, MD: Affiliations. ...
Journal of the American Academy of Dermatology, 2004
Inverse psoriasis can be difficult to treat because of the high sensitivity of intertriginous are... more Inverse psoriasis can be difficult to treat because of the high sensitivity of intertriginous areas to cutaneous side effects, such as irritation and striae. Pimecrolimus, a well-tolerated, nonatrophogenic, skin-selective inflammatory cytokine inhibitor, has been shown to be effective in the treatment of psoriasis when applied topically under occlusion. This study evaluated the efficacy and safety of pimecrolimus cream 1% versus vehicle twice a day in the treatment of inverse psoriasis. Methods This was a double-blind, randomized, vehicle-controlled study in 57 patients with moderate to severe inverse psoriasis. Patients were evaluated using Investigator's Global Assessment of overall severity, Target Area Score, and Patient Self-Assessment. A significant between-group difference was observed early on, with 54% of the pimecrolimus group versus 21% of the vehicle group having an Investigator's Global Assessment score of 0 or 1 (clear or almost clear) at week 2 ( P = .0169). By week 8, 71% of the pimecrolimus group had an Investigator's Global Assessment score of 0 or 1. Change from baseline in Target Area Score was -2.4 (pimecrolimus group) compared with -0.7 (vehicle) at day 3 ( P < .0001). By week 8, 82% of patients using pimecrolimus scored their disease as well or completely controlled versus 41% of the vehicle group ( P = .0007). Adverse events were similar between groups. Pimecrolimus cream 1% is an effective treatment for inverse psoriasis with a rapid onset of action, and is safe and well-tolerated.
... preliminary findings from a 12-week dose-ranging trial☆. Diana M. Chen, MD: Affiliations. Abb... more ... preliminary findings from a 12-week dose-ranging trial☆. Diana M. Chen, MD: Affiliations. Abbott Laboratories, Abbott Park, IL, United States USA; Diana Chen, MD, is employed by Abbott Laboratories. ,; Kenneth Gordon, MD: Affiliations. ...
BACKGROUND: Inverse psoriasis can be difficult to treat because of the high sensitivity of intert... more BACKGROUND: Inverse psoriasis can be difficult to treat because of the high sensitivity of intertriginous areas to cutaneous side effects, such as irritation and striae. Pimecrolimus, a well-tolerated, nonatrophogenic, skin-selective inflammatory cytokine inhibitor, has been ...
Journal of the American Academy of Dermatology, Aug 1, 2017
Labeling and effectiveness testing; sunscreen drug products for over-the-counter human use. Final... more Labeling and effectiveness testing; sunscreen drug products for over-the-counter human use. Final rule. Fed Regist. 2011; 76(117):35620-35665. 4. Wang SQ, Stanfield JW, Osterwalder U. In vitro assessments of UVA protection by popular sunscreens available in the United States.
Journal of the American Academy of Dermatology, 1998
Bullous pemphigoid is a blistering disorder characterized by antibody deposition in the lamina lu... more Bullous pemphigoid is a blistering disorder characterized by antibody deposition in the lamina lucida of the basement membrane zone. In addition to the idiopathic form, there are many agents that have been implicated in inducing bullous pemphigoid or bullous pemphigoid-like lesions. We describe a patient who developed a bullous pemphigoid-like eruption after a chemical burn. (J Am Acad Dermatol 1998;38:337-40.) Bullous pemphigoid (BP) and bullous pemphigoid-like skin eruptions have occurred after physical trauma, 1 thermal burns, 2 ultraviolet light exposure, 3,4 radiotherapy, 5 and systemic medications. 6-8 We describe an unusual presentation of a bullous pemphigoid-like skin eruption after exposure to isothiazolinone and glutaraldehyde.
Cutis Cutaneous Medicine For the Practitioner, Nov 1, 2010
The acne-specific quality of life (Acne-QoL) questionnaire was developed to measure the impact of... more The acne-specific quality of life (Acne-QoL) questionnaire was developed to measure the impact of facial acne across 4 domains (acne symptoms, role-emotional, self-perception, role-social) of health-related quality of life (HRQL). This analysis assessed the impact of clindamycin phosphate 1.2%-benzoyl peroxide 2.5% (clindamycin-BPO 2.5%) gel on HRQL in a combined study population (N = 2813) of participants with moderate to severe acne vulgaris. Although the results presented within do not include factors of study and study-by-treatment interaction, analyses were performed to confirm that the results were consistent across the 2 identical, double-blind, randomized studies and within each treatment group across studies to justify pooling the data from both studies. The Acne-QoL questionnaire was administered at baseline and at the end of treatment (week 12). Treatment with clindamycin-BPO 2.5% gel significantly improved participant-reported HRQL across all 4 domains compared with individual active ingredients and vehicle (P < .001). The percentage improvement in mean Acne-QoL domain scores with clindamycin-BPO 2.5% gel ranged from 37% to 59%. Because the negative impact of facial acne on HRQL is one of the primary motivators for patients to seek treatment, this analysis underscores the importance of physicians incorporating assessments of HRQL into their clinical decision making.
Journal of the American Academy of Dermatology, 2000
Examination showed several extensive patches of cicatricial alopecia . Hyperpigmented nummular pl... more Examination showed several extensive patches of cicatricial alopecia . Hyperpigmented nummular plaques were noted over the face, trunk, and extremities. Biopsy specimens from an area of alopecia and a trunk lesion showed similar findings, with noncaseating granulomatous inflammation. Staining with Gram, periodic acid-Schiff, and Ziehl-Nielsen was negative, as was polarization. The patient noted no improvement in the alopecia with topical steroids, oral hydroxychloroquine, or intermittent oral prednisone.
ABSTRACT Abstract Objective: To evaluate the efficacy and tolerability of the fixed-combination b... more ABSTRACT Abstract Objective: To evaluate the efficacy and tolerability of the fixed-combination brimonidine 0.2%/timolol 0.5% (FCBT) compared with the fixed-combination dorzolamide 2%/timolol 0.5% (FCDT) in the treatment of patients with elevated intraocular pressure (IOP). Methods: Pertinent randomized controlled trials comparing FCBT with FCDT in patients with elevated IOP were identified through systematic searches of the Cochrane Library, PubMed, and EMBASE. The main efficacy measures were the IOP reduction (IOPR), including diurnal mean IOPR, and peak IOPR. The main tolerability measure was the individual adverse events. The pooled estimates and 95% confidence intervals (CIs) were carried out in RevMan version 5.0 software. Results: Seven studies involving 582 patients were included in the meta-analysis. With a weighted mean difference (WMD) of IOPR in diurnal mean of 0.44 mmHg (95% CI, 0.00-0.88), the FCBT was as effective as FCDT in lowering IOP in patients with elevated IOP (P=0.05). The WMD of IOPR at peak was 0.65 mmHg (95% CI, -0.06 to 1.35) (P=0.76), and there was no significant difference between FCBT and FCDT. FCBT caused burning/stinging in less patients than FCDT [pooled relative risk: 0.45 (95% CI, 0.29-0.70)]. Conclusions: Both FCBT and FCDT can effectively lower IOP in patients with elevated IOP, and the IOP-lowering efficacy of FCBT is noninferior to that of FCDT. Additionally, FCBT affords an ocular comfort advantage compared with FCDT.
Oral antibiotics are commonly prescribed for moderate or severe acne, but there may be limitation... more Oral antibiotics are commonly prescribed for moderate or severe acne, but there may be limitations due to concerns about side effects associated with systemic treatments. To evaluate the efficacy and safety of a fixed combination clindamycin phosphate 1.2% and benzoyl peroxide 2.5% (clindamycin-BP 2.5%) aqueous gel in the treatment of moderate or severe acne subpopulations. Two multicenter, double-blind studies randomized 2,813 subjects with moderate or severe acne to clindamycin-BP 2.5% gel, each active ingredient, or vehicle gel, once daily for 12 weeks. Efficacy evaluations included inflammatory and non-inflammatory lesion counts and evaluator's global severity score at baseline and weeks 4, 8 and 12. Adverse events and subjects' evaluations of product tolerability were also monitored. Subpopulation efficacy and safety analyses by baseline acne severity were performed for the combined data from the two phase 3 studies. Clindamycin-BP 2.5% gel significantly reduced inflamm...
IMPORTANCE Little is known about patients&amp... more IMPORTANCE Little is known about patients' experiences of advanced basal cell carcinoma (aBCC) and basal cell carcinoma nevus syndrome (BCCNS), a rare genetic disorder that greatly increases the number of BCCs. OBJECTIVE To develop a questionnaire to measure patient-reported outcomes (PROs) in these populations. DESIGN, SETTING, AND PARTICIPANTS Concept elicitation interviews were conducted with patients with aBCC and BCCNS from 5 US clinical sites and the BCCNS Life Support Network and 4 physicians. The PRO questionnaires were drafted based on results from a literature review and findings from these interviews. Questionnaires were finalized after cognitive debriefing interviews were conducted with patients. Concept elicitation interviews were conducted with 30 patients (14 with aBCC, 16 with BCCNS) and 4 physicians (2 dermatologists, 1 Mohs surgeon, and 1 oncologist) in the United States. A subset of 10 of these patients (5 with aBCC, 5 with BCCNS) took part in cognitive debriefing interviews. MAIN OUTCOMES AND MEASURES Development of 2 questionnaires to allow clinicians to assess the emotional, social, and physical impacts of the disease on patients with aBCC and BCCNS. RESULTS Most concept elicitation interview patients were male (63%) and white (93%); their mean age was 57 years. There were impacts on emotional, social, and physical functioning in both conditions. Patients were unable to do many activities and avoided other activities. Seventy-nine percent of patients with aBCC and all patients with BCCNS reported scarring. Physician interviews revealed similar findings. During cognitive debriefing interviews, the questionnaires were found to be relevant, clear, and comprehensive. CONCLUSIONS AND RELEVANCE Advanced BCC and BCCNS affect patients in unique and substantial ways. These PRO questionnaires were developed with patient and clinician input and measure the key areas that have an impact on patients with these conditions.
Journal of the American Academy of Dermatology, 2008
Objective: We sought to evaluate efficacy, safety, and tolerability of a combination of clindamyc... more Objective: We sought to evaluate efficacy, safety, and tolerability of a combination of clindamycin phosphate 1.2% and benzoyl peroxide 2.5% (clindamycin-BPO 2.5%) aqueous gel in moderate to severe acne vulgaris.
Journal of the American Academy of Dermatology, 2014
Background: Vismodegib, a first-in-class Hedgehog pathway inhibitor, was US Food and Drug Adminis... more Background: Vismodegib, a first-in-class Hedgehog pathway inhibitor, was US Food and Drug Administration (FDA) approved for advanced basal cell carcinomas (BCCs) based on a single, nonrandomized, phase-II trial. Consequently, additional clinical data are critical to confirm the efficacy and safety of vismodegib. Objective: We sought to assess efficacy and safety of vismodegib, while providing early drug access to patients with advanced BCC and limited treatment options. Methods: This was an open-label, multicenter study in patients with advanced BCC inappropriate for radiotherapy or surgery. Patients received 150 mg vismodegib daily until disease progression or intolerable toxicity. Tumor response was assessed via Response Evaluation Criteria in Solid Tumors version 1.0. Results: A total of 119 patients with advanced BCC took vismodegib for a median of 5.5 months. Objective responses occurred in 46.4% of locally advanced BCC and 30.8% of patients with metastatic BCC. Response was negatively associated with prior systemic therapy in patients with locally advanced BCC (P = .002). Mean follow-up for safety was 6.5 months, with muscle spasms (70.6%), dysgeusia (70.6%), alopecia (58.0%), and diarrhea (25.2%) as the most common adverse events. Limitations: Abbreviated follow-up time because of study termination upon FDA approval was a limitation. Conclusion: This study provides important clinical data supporting the efficacy and safety of vismodegib. Larger studies are underway to assess predictors of response and long-term outcomes.
Products that may cause irritation are widely used to treat acne. Irritation has the potential to... more Products that may cause irritation are widely used to treat acne. Irritation has the potential to reduce treatment adherence. How patients manage irritation and dryness is not well characterized. To study self-reported irritation, its impact and coping mechanisms in patients who had been treated for acne with a clindamycin-5% benzoyl peroxide (BPO) product. An Internet-based survey of 200 subjects, aged 15-40 years who had used a clindamycin-5% BPO fixed combination product in the last six months on at least 50 percent of their face, at least five days per week. The majority of subjects (57%) had moderate acne, 28 percent had severe acne. Bothersome side effects of the clindamycin-5% BPO combination included dry skin (55%), flaky/peeling skin (45%), irritated skin (44%), itchy skin (39%) and redness (37%). As a result, subjects used the product only as a spot treatment (33%), only when breakouts seemed worse (28%), or less often than recommended (32%); stopped using from time to time (32%); switched to a different prescription medication and/or an over-the-counter acne product (28%); or stopped using altogether (10%). 41 percent of subjects reported using moisturizers to counteract dryness and redness. We queried patients concerning use of combination clindamycin/BPO products and not other products. Irritation to clindamycin-5% BPO is a common problem that reduces patients' use of the medication. Strategies to improve treatment include communication with patients on possible side effects, providing written instruction on how to manage irritation and dryness and consideration of alternative topical treatments and treatment regimens.
Journal of the American Academy of Dermatology, 2004
... preliminary findings from a 12-week dose-ranging trial☆. Diana M. Chen, MD: Affiliations. Abb... more ... preliminary findings from a 12-week dose-ranging trial☆. Diana M. Chen, MD: Affiliations. Abbott Laboratories, Abbott Park, IL, United States USA; Diana Chen, MD, is employed by Abbott Laboratories. ,; Kenneth Gordon, MD: Affiliations. ...
Journal of the American Academy of Dermatology, 2004
Inverse psoriasis can be difficult to treat because of the high sensitivity of intertriginous are... more Inverse psoriasis can be difficult to treat because of the high sensitivity of intertriginous areas to cutaneous side effects, such as irritation and striae. Pimecrolimus, a well-tolerated, nonatrophogenic, skin-selective inflammatory cytokine inhibitor, has been shown to be effective in the treatment of psoriasis when applied topically under occlusion. This study evaluated the efficacy and safety of pimecrolimus cream 1% versus vehicle twice a day in the treatment of inverse psoriasis. Methods This was a double-blind, randomized, vehicle-controlled study in 57 patients with moderate to severe inverse psoriasis. Patients were evaluated using Investigator's Global Assessment of overall severity, Target Area Score, and Patient Self-Assessment. A significant between-group difference was observed early on, with 54% of the pimecrolimus group versus 21% of the vehicle group having an Investigator's Global Assessment score of 0 or 1 (clear or almost clear) at week 2 ( P = .0169). By week 8, 71% of the pimecrolimus group had an Investigator's Global Assessment score of 0 or 1. Change from baseline in Target Area Score was -2.4 (pimecrolimus group) compared with -0.7 (vehicle) at day 3 ( P < .0001). By week 8, 82% of patients using pimecrolimus scored their disease as well or completely controlled versus 41% of the vehicle group ( P = .0007). Adverse events were similar between groups. Pimecrolimus cream 1% is an effective treatment for inverse psoriasis with a rapid onset of action, and is safe and well-tolerated.
... preliminary findings from a 12-week dose-ranging trial☆. Diana M. Chen, MD: Affiliations. Abb... more ... preliminary findings from a 12-week dose-ranging trial☆. Diana M. Chen, MD: Affiliations. Abbott Laboratories, Abbott Park, IL, United States USA; Diana Chen, MD, is employed by Abbott Laboratories. ,; Kenneth Gordon, MD: Affiliations. ...
BACKGROUND: Inverse psoriasis can be difficult to treat because of the high sensitivity of intert... more BACKGROUND: Inverse psoriasis can be difficult to treat because of the high sensitivity of intertriginous areas to cutaneous side effects, such as irritation and striae. Pimecrolimus, a well-tolerated, nonatrophogenic, skin-selective inflammatory cytokine inhibitor, has been ...
Journal of the American Academy of Dermatology, Aug 1, 2017
Labeling and effectiveness testing; sunscreen drug products for over-the-counter human use. Final... more Labeling and effectiveness testing; sunscreen drug products for over-the-counter human use. Final rule. Fed Regist. 2011; 76(117):35620-35665. 4. Wang SQ, Stanfield JW, Osterwalder U. In vitro assessments of UVA protection by popular sunscreens available in the United States.
Journal of the American Academy of Dermatology, 1998
Bullous pemphigoid is a blistering disorder characterized by antibody deposition in the lamina lu... more Bullous pemphigoid is a blistering disorder characterized by antibody deposition in the lamina lucida of the basement membrane zone. In addition to the idiopathic form, there are many agents that have been implicated in inducing bullous pemphigoid or bullous pemphigoid-like lesions. We describe a patient who developed a bullous pemphigoid-like eruption after a chemical burn. (J Am Acad Dermatol 1998;38:337-40.) Bullous pemphigoid (BP) and bullous pemphigoid-like skin eruptions have occurred after physical trauma, 1 thermal burns, 2 ultraviolet light exposure, 3,4 radiotherapy, 5 and systemic medications. 6-8 We describe an unusual presentation of a bullous pemphigoid-like skin eruption after exposure to isothiazolinone and glutaraldehyde.
Cutis Cutaneous Medicine For the Practitioner, Nov 1, 2010
The acne-specific quality of life (Acne-QoL) questionnaire was developed to measure the impact of... more The acne-specific quality of life (Acne-QoL) questionnaire was developed to measure the impact of facial acne across 4 domains (acne symptoms, role-emotional, self-perception, role-social) of health-related quality of life (HRQL). This analysis assessed the impact of clindamycin phosphate 1.2%-benzoyl peroxide 2.5% (clindamycin-BPO 2.5%) gel on HRQL in a combined study population (N = 2813) of participants with moderate to severe acne vulgaris. Although the results presented within do not include factors of study and study-by-treatment interaction, analyses were performed to confirm that the results were consistent across the 2 identical, double-blind, randomized studies and within each treatment group across studies to justify pooling the data from both studies. The Acne-QoL questionnaire was administered at baseline and at the end of treatment (week 12). Treatment with clindamycin-BPO 2.5% gel significantly improved participant-reported HRQL across all 4 domains compared with individual active ingredients and vehicle (P < .001). The percentage improvement in mean Acne-QoL domain scores with clindamycin-BPO 2.5% gel ranged from 37% to 59%. Because the negative impact of facial acne on HRQL is one of the primary motivators for patients to seek treatment, this analysis underscores the importance of physicians incorporating assessments of HRQL into their clinical decision making.
Journal of the American Academy of Dermatology, 2000
Examination showed several extensive patches of cicatricial alopecia . Hyperpigmented nummular pl... more Examination showed several extensive patches of cicatricial alopecia . Hyperpigmented nummular plaques were noted over the face, trunk, and extremities. Biopsy specimens from an area of alopecia and a trunk lesion showed similar findings, with noncaseating granulomatous inflammation. Staining with Gram, periodic acid-Schiff, and Ziehl-Nielsen was negative, as was polarization. The patient noted no improvement in the alopecia with topical steroids, oral hydroxychloroquine, or intermittent oral prednisone.
ABSTRACT Abstract Objective: To evaluate the efficacy and tolerability of the fixed-combination b... more ABSTRACT Abstract Objective: To evaluate the efficacy and tolerability of the fixed-combination brimonidine 0.2%/timolol 0.5% (FCBT) compared with the fixed-combination dorzolamide 2%/timolol 0.5% (FCDT) in the treatment of patients with elevated intraocular pressure (IOP). Methods: Pertinent randomized controlled trials comparing FCBT with FCDT in patients with elevated IOP were identified through systematic searches of the Cochrane Library, PubMed, and EMBASE. The main efficacy measures were the IOP reduction (IOPR), including diurnal mean IOPR, and peak IOPR. The main tolerability measure was the individual adverse events. The pooled estimates and 95% confidence intervals (CIs) were carried out in RevMan version 5.0 software. Results: Seven studies involving 582 patients were included in the meta-analysis. With a weighted mean difference (WMD) of IOPR in diurnal mean of 0.44 mmHg (95% CI, 0.00-0.88), the FCBT was as effective as FCDT in lowering IOP in patients with elevated IOP (P=0.05). The WMD of IOPR at peak was 0.65 mmHg (95% CI, -0.06 to 1.35) (P=0.76), and there was no significant difference between FCBT and FCDT. FCBT caused burning/stinging in less patients than FCDT [pooled relative risk: 0.45 (95% CI, 0.29-0.70)]. Conclusions: Both FCBT and FCDT can effectively lower IOP in patients with elevated IOP, and the IOP-lowering efficacy of FCBT is noninferior to that of FCDT. Additionally, FCBT affords an ocular comfort advantage compared with FCDT.
Oral antibiotics are commonly prescribed for moderate or severe acne, but there may be limitation... more Oral antibiotics are commonly prescribed for moderate or severe acne, but there may be limitations due to concerns about side effects associated with systemic treatments. To evaluate the efficacy and safety of a fixed combination clindamycin phosphate 1.2% and benzoyl peroxide 2.5% (clindamycin-BP 2.5%) aqueous gel in the treatment of moderate or severe acne subpopulations. Two multicenter, double-blind studies randomized 2,813 subjects with moderate or severe acne to clindamycin-BP 2.5% gel, each active ingredient, or vehicle gel, once daily for 12 weeks. Efficacy evaluations included inflammatory and non-inflammatory lesion counts and evaluator's global severity score at baseline and weeks 4, 8 and 12. Adverse events and subjects' evaluations of product tolerability were also monitored. Subpopulation efficacy and safety analyses by baseline acne severity were performed for the combined data from the two phase 3 studies. Clindamycin-BP 2.5% gel significantly reduced inflamm...
IMPORTANCE Little is known about patients&amp... more IMPORTANCE Little is known about patients' experiences of advanced basal cell carcinoma (aBCC) and basal cell carcinoma nevus syndrome (BCCNS), a rare genetic disorder that greatly increases the number of BCCs. OBJECTIVE To develop a questionnaire to measure patient-reported outcomes (PROs) in these populations. DESIGN, SETTING, AND PARTICIPANTS Concept elicitation interviews were conducted with patients with aBCC and BCCNS from 5 US clinical sites and the BCCNS Life Support Network and 4 physicians. The PRO questionnaires were drafted based on results from a literature review and findings from these interviews. Questionnaires were finalized after cognitive debriefing interviews were conducted with patients. Concept elicitation interviews were conducted with 30 patients (14 with aBCC, 16 with BCCNS) and 4 physicians (2 dermatologists, 1 Mohs surgeon, and 1 oncologist) in the United States. A subset of 10 of these patients (5 with aBCC, 5 with BCCNS) took part in cognitive debriefing interviews. MAIN OUTCOMES AND MEASURES Development of 2 questionnaires to allow clinicians to assess the emotional, social, and physical impacts of the disease on patients with aBCC and BCCNS. RESULTS Most concept elicitation interview patients were male (63%) and white (93%); their mean age was 57 years. There were impacts on emotional, social, and physical functioning in both conditions. Patients were unable to do many activities and avoided other activities. Seventy-nine percent of patients with aBCC and all patients with BCCNS reported scarring. Physician interviews revealed similar findings. During cognitive debriefing interviews, the questionnaires were found to be relevant, clear, and comprehensive. CONCLUSIONS AND RELEVANCE Advanced BCC and BCCNS affect patients in unique and substantial ways. These PRO questionnaires were developed with patient and clinician input and measure the key areas that have an impact on patients with these conditions.
Journal of the American Academy of Dermatology, 2008
Objective: We sought to evaluate efficacy, safety, and tolerability of a combination of clindamyc... more Objective: We sought to evaluate efficacy, safety, and tolerability of a combination of clindamycin phosphate 1.2% and benzoyl peroxide 2.5% (clindamycin-BPO 2.5%) aqueous gel in moderate to severe acne vulgaris.
Uploads
Papers by Diana Chen