Tretinoin/Benzoyl Morning Dose Safe, Effective

Major Finding: A morning/morning regimen of 5% benzoyl peroxide wash plus tretinoin gel microsphere 0.04% is as safe and effective as a morning/evening regimen.

Data Source: Randomized, investigator-blinded, phase IV trial of 247 patients with moderate acne.

Disclosures: The study was sponsored by Johnson & Johnson, whose Ortho Dermatologics division markets the Retin-A Micro Pump. Two of the study investigators are employees of Johnson & Johnson, and several others have served as investigators for the company, including Dr. Fried. One of the authors owns stock in Johnson & Johnson.

Studies have shown that a combination of tretinoin and benzoyl peroxide is effective in treating acne; however, the products usually are not administered simultaneously. Tretinoin tends to be degraded by sunlight, so it is typically dosed in the evening. In addition, benzoyl peroxide hastens the breakdown of tretinoin.

But a new study suggests that when the tretinoin is delivered in a gel microsphere pump, the two agents are safe and effective when applied together in the morning (J. Drugs Dermatol. 2010;9:805-13).

The multicenter, phase IV study involved 247 otherwise healthy patients with moderate facial acne vulgaris who were randomized to a 12-week regimen of morning/morning treatment or morning/evening treatment. Physicians monitoring the patients were blinded to their group assignment.

The morning/morning group used a 5% benzoyl peroxide wash, then immediately applied two full pumps of the tretinoin gel microsphere (TGM) 0.04% (Retin-A Micro Pump). The morning/evening group applied the benzoyl peroxide each morning and the TGM pump each evening.

The mean age of the patients was 18.5 years, and 51% were female. At the outset, patients' mean acne lesion count was 72.7, of which 27.4 lesions were inflammatory and 45.3 lesions were noninflammatory. Two-thirds of the patients were white, 19% were Hispanic, 10% were black. The rest were of other or mixed races.

At 12 weeks, the mean lesion count of the patients in the morning/morning group was 39.2, compared with 41.4 in the morning/evening group. The difference was not significant. A separate statistical test demonstrated that the morning/morning regimen was “noninferior” to the morning/evening regimen.

In terms of Investigator's Global Assessment (IGA) score, 23.4% of patients in the morning/morning group and 21.9% in the morning/evening group were judged to be clear or almost clear of their acne lesions. Also, 45.9% of the patients in the morning/morning group and 47.4% in the morning/evening group improved by at least two IGA grades. Neither of these differences were significant.

There were no significant differences in side effects between the two groups. Patients in both groups experienced similar degrees of erythema, dryness, peeling/scaling, burning/stinging, and itching. Investigators described both regimens as “well tolerated.” Thirteen patients in the morning/morning group and 12 patients in the morning/evening group dropped out of the study.

In a statement, study coauthor Dr. Richard Fried, a dermatologist in Yardley, Penn., noted: “These newly published study results are significant for both acne patients and dermatologists as they reinforce the ability to develop skin care regimens that cater to each individual patient's lifestyle, which is important, as simple protocols provide the best chance for clear, beautiful skin.”

Major Finding: A morning/morning regimen of 5% benzoyl peroxide wash plus tretinoin gel microsphere 0.04% is as safe and effective as a morning/evening regimen.

Data Source: Randomized, investigator-blinded, phase IV trial of 247 patients with moderate acne.

Disclosures: The study was sponsored by Johnson & Johnson, whose Ortho Dermatologics division markets the Retin-A Micro Pump. Two of the study investigators are employees of Johnson & Johnson, and several others have served as investigators for the company, including Dr. Fried. One of the authors owns stock in Johnson & Johnson.

Studies have shown that a combination of tretinoin and benzoyl peroxide is effective in treating acne; however, the products usually are not administered simultaneously. Tretinoin tends to be degraded by sunlight, so it is typically dosed in the evening. In addition, benzoyl peroxide hastens the breakdown of tretinoin.

But a new study suggests that when the tretinoin is delivered in a gel microsphere pump, the two agents are safe and effective when applied together in the morning (J. Drugs Dermatol. 2010;9:805-13).

The multicenter, phase IV study involved 247 otherwise healthy patients with moderate facial acne vulgaris who were randomized to a 12-week regimen of morning/morning treatment or morning/evening treatment. Physicians monitoring the patients were blinded to their group assignment.

The morning/morning group used a 5% benzoyl peroxide wash, then immediately applied two full pumps of the tretinoin gel microsphere (TGM) 0.04% (Retin-A Micro Pump). The morning/evening group applied the benzoyl peroxide each morning and the TGM pump each evening.

The mean age of the patients was 18.5 years, and 51% were female. At the outset, patients' mean acne lesion count was 72.7, of which 27.4 lesions were inflammatory and 45.3 lesions were noninflammatory. Two-thirds of the patients were white, 19% were Hispanic, 10% were black. The rest were of other or mixed races.

At 12 weeks, the mean lesion count of the patients in the morning/morning group was 39.2, compared with 41.4 in the morning/evening group. The difference was not significant. A separate statistical test demonstrated that the morning/morning regimen was “noninferior” to the morning/evening regimen.

In terms of Investigator's Global Assessment (IGA) score, 23.4% of patients in the morning/morning group and 21.9% in the morning/evening group were judged to be clear or almost clear of their acne lesions. Also, 45.9% of the patients in the morning/morning group and 47.4% in the morning/evening group improved by at least two IGA grades. Neither of these differences were significant.

There were no significant differences in side effects between the two groups. Patients in both groups experienced similar degrees of erythema, dryness, peeling/scaling, burning/stinging, and itching. Investigators described both regimens as “well tolerated.” Thirteen patients in the morning/morning group and 12 patients in the morning/evening group dropped out of the study.

In a statement, study coauthor Dr. Richard Fried, a dermatologist in Yardley, Penn., noted: “These newly published study results are significant for both acne patients and dermatologists as they reinforce the ability to develop skin care regimens that cater to each individual patient's lifestyle, which is important, as simple protocols provide the best chance for clear, beautiful skin.”

Major Finding: A morning/morning regimen of 5% benzoyl peroxide wash plus tretinoin gel microsphere 0.04% is as safe and effective as a morning/evening regimen.

Data Source: Randomized, investigator-blinded, phase IV trial of 247 patients with moderate acne.

Disclosures: The study was sponsored by Johnson & Johnson, whose Ortho Dermatologics division markets the Retin-A Micro Pump. Two of the study investigators are employees of Johnson & Johnson, and several others have served as investigators for the company, including Dr. Fried. One of the authors owns stock in Johnson & Johnson.

Studies have shown that a combination of tretinoin and benzoyl peroxide is effective in treating acne; however, the products usually are not administered simultaneously. Tretinoin tends to be degraded by sunlight, so it is typically dosed in the evening. In addition, benzoyl peroxide hastens the breakdown of tretinoin.

But a new study suggests that when the tretinoin is delivered in a gel microsphere pump, the two agents are safe and effective when applied together in the morning (J. Drugs Dermatol. 2010;9:805-13).

The multicenter, phase IV study involved 247 otherwise healthy patients with moderate facial acne vulgaris who were randomized to a 12-week regimen of morning/morning treatment or morning/evening treatment. Physicians monitoring the patients were blinded to their group assignment.

The morning/morning group used a 5% benzoyl peroxide wash, then immediately applied two full pumps of the tretinoin gel microsphere (TGM) 0.04% (Retin-A Micro Pump). The morning/evening group applied the benzoyl peroxide each morning and the TGM pump each evening.

The mean age of the patients was 18.5 years, and 51% were female. At the outset, patients' mean acne lesion count was 72.7, of which 27.4 lesions were inflammatory and 45.3 lesions were noninflammatory. Two-thirds of the patients were white, 19% were Hispanic, 10% were black. The rest were of other or mixed races.

At 12 weeks, the mean lesion count of the patients in the morning/morning group was 39.2, compared with 41.4 in the morning/evening group. The difference was not significant. A separate statistical test demonstrated that the morning/morning regimen was “noninferior” to the morning/evening regimen.

In terms of Investigator's Global Assessment (IGA) score, 23.4% of patients in the morning/morning group and 21.9% in the morning/evening group were judged to be clear or almost clear of their acne lesions. Also, 45.9% of the patients in the morning/morning group and 47.4% in the morning/evening group improved by at least two IGA grades. Neither of these differences were significant.

There were no significant differences in side effects between the two groups. Patients in both groups experienced similar degrees of erythema, dryness, peeling/scaling, burning/stinging, and itching. Investigators described both regimens as “well tolerated.” Thirteen patients in the morning/morning group and 12 patients in the morning/evening group dropped out of the study.

In a statement, study coauthor Dr. Richard Fried, a dermatologist in Yardley, Penn., noted: “These newly published study results are significant for both acne patients and dermatologists as they reinforce the ability to develop skin care regimens that cater to each individual patient's lifestyle, which is important, as simple protocols provide the best chance for clear, beautiful skin.”