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Assessment of local skin reactions with a sequential regimen of cryosurgery followed by ingenol mebutate gel, 0.015%, in patients with actinic keratosis.

Goldenberg G, Berman B - Clin Cosmet Investig Dermatol (2014)

Bottom Line: Therapeutic approaches that combine both types of therapies may improve the successful elimination of AKs.The mean (95% confidence interval) composite score (maximum range, 0-24) for these reactions was higher in patients with treatment of AKs on the face, 9.3 (8.5-10.1), as compared with the scalp, 5.8 (4.3-7.4).These results show that local skin reactions associated with ingenol mebutate treatment of the face or scalp are well tolerated after recent cryosurgery.

View Article: PubMed Central - PubMed

Affiliation: Department of Dermatology, Mount Sinai School of Medicine, New York, NY, USA.

ABSTRACT
Lesion-directed and field-directed therapies are used to treat actinic keratosis (AK). Therapeutic approaches that combine both types of therapies may improve the successful elimination of AKs. A randomized, double-blind, vehicle-controlled study evaluated the safety, tolerability, and efficacy of topical field treatment with ingenol mebutate gel, 0.015%, after cryosurgery to AKs on the face and scalp. Patients with 4-8 visible discrete AKs in a 25-cm(2) contiguous area received cryosurgery of all AKs at baseline. After a 3-week healing period, patients applied ingenol mebutate gel, 0.015%, or vehicle gel once daily for 3 consecutive days to the treatment area. The incidence, severity, and time course of the development and resolution of local skin reactions were measured from baseline to week 11. Local skin reactions peaked shortly after completion of ingenol mebutate treatment and generally resolved within 2 weeks. The mean (95% confidence interval) composite score (maximum range, 0-24) for these reactions was higher in patients with treatment of AKs on the face, 9.3 (8.5-10.1), as compared with the scalp, 5.8 (4.3-7.4). Erythema and flaking/scaling were the major contributors to the composite local skin reaction score. These results show that local skin reactions associated with ingenol mebutate treatment of the face or scalp are well tolerated after recent cryosurgery.

No MeSH data available.


Related in: MedlinePlus

Individual LSRs experienced at visit 3 by patients treated on the (A) face (n=120) or (B) scalp (n=36) with ingenol mebutate, graded on a scale of 0 to 4, with higher numbers indicating greater severity.Abbreviation: LSRs, local skin reactions.
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f5-ccid-8-001: Individual LSRs experienced at visit 3 by patients treated on the (A) face (n=120) or (B) scalp (n=36) with ingenol mebutate, graded on a scale of 0 to 4, with higher numbers indicating greater severity.Abbreviation: LSRs, local skin reactions.

Mentions: At the time of peak LSR development (visit 3), grade 4 component LSRs were infrequent. Of patients who treated the face, 27.5%, 13.3%, and 11.7% had grade 4 reactions of erythema, flaking/scaling, and crusting reactions, respectively (Figure 5A); among patients treating the scalp, the corresponding frequencies were 5.6%, 2.8%, and 2.8%. For the parameters of swelling, vesiculation/pustulation, and erosion/ulceration, grade 4 reactions occurred in <9% and <3% of patients treating the face and scalp, respectively (Figure 5A and B).


Assessment of local skin reactions with a sequential regimen of cryosurgery followed by ingenol mebutate gel, 0.015%, in patients with actinic keratosis.

Goldenberg G, Berman B - Clin Cosmet Investig Dermatol (2014)

Individual LSRs experienced at visit 3 by patients treated on the (A) face (n=120) or (B) scalp (n=36) with ingenol mebutate, graded on a scale of 0 to 4, with higher numbers indicating greater severity.Abbreviation: LSRs, local skin reactions.
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4274044&req=5

f5-ccid-8-001: Individual LSRs experienced at visit 3 by patients treated on the (A) face (n=120) or (B) scalp (n=36) with ingenol mebutate, graded on a scale of 0 to 4, with higher numbers indicating greater severity.Abbreviation: LSRs, local skin reactions.
Mentions: At the time of peak LSR development (visit 3), grade 4 component LSRs were infrequent. Of patients who treated the face, 27.5%, 13.3%, and 11.7% had grade 4 reactions of erythema, flaking/scaling, and crusting reactions, respectively (Figure 5A); among patients treating the scalp, the corresponding frequencies were 5.6%, 2.8%, and 2.8%. For the parameters of swelling, vesiculation/pustulation, and erosion/ulceration, grade 4 reactions occurred in <9% and <3% of patients treating the face and scalp, respectively (Figure 5A and B).

Bottom Line: Therapeutic approaches that combine both types of therapies may improve the successful elimination of AKs.The mean (95% confidence interval) composite score (maximum range, 0-24) for these reactions was higher in patients with treatment of AKs on the face, 9.3 (8.5-10.1), as compared with the scalp, 5.8 (4.3-7.4).These results show that local skin reactions associated with ingenol mebutate treatment of the face or scalp are well tolerated after recent cryosurgery.

View Article: PubMed Central - PubMed

Affiliation: Department of Dermatology, Mount Sinai School of Medicine, New York, NY, USA.

ABSTRACT
Lesion-directed and field-directed therapies are used to treat actinic keratosis (AK). Therapeutic approaches that combine both types of therapies may improve the successful elimination of AKs. A randomized, double-blind, vehicle-controlled study evaluated the safety, tolerability, and efficacy of topical field treatment with ingenol mebutate gel, 0.015%, after cryosurgery to AKs on the face and scalp. Patients with 4-8 visible discrete AKs in a 25-cm(2) contiguous area received cryosurgery of all AKs at baseline. After a 3-week healing period, patients applied ingenol mebutate gel, 0.015%, or vehicle gel once daily for 3 consecutive days to the treatment area. The incidence, severity, and time course of the development and resolution of local skin reactions were measured from baseline to week 11. Local skin reactions peaked shortly after completion of ingenol mebutate treatment and generally resolved within 2 weeks. The mean (95% confidence interval) composite score (maximum range, 0-24) for these reactions was higher in patients with treatment of AKs on the face, 9.3 (8.5-10.1), as compared with the scalp, 5.8 (4.3-7.4). Erythema and flaking/scaling were the major contributors to the composite local skin reaction score. These results show that local skin reactions associated with ingenol mebutate treatment of the face or scalp are well tolerated after recent cryosurgery.

No MeSH data available.


Related in: MedlinePlus