PMID- 12852366
OWN - NLM
STAT- MEDLINE
DCOM- 20030806
LR  - 20131121
IS  - 1545-9616 (Print)
IS  - 1545-9616 (Linking)
VI  - 2
IP  - 2
DP  - 2003 Apr
TI  - A promising new treatment for solar lentigines.
PG  - 147-52
AB  - The purpose of this open-label study was to determine the adverse event rate of 
      topical 4HA/tretinoin when used twice daily for up to 24 weeks with concomitant 
      sunscreen in the treatment of solar lentigines and related hyperpigmented 
      lesions. There were two treatment areas: bilateral dorsal forearms, including the 
      back of the hands; and the face, including the forehead and cheek areas. Each 
      treatment area had a target lesion at least 5 mm in diameter and was moderately 
      darker than the surrounding skin. A nine-point bipolar scale was used for 
      evaluation of Target Lesion Pigmentation (0 = extremely lighter than pigment of 
      the surrounding skin, 4 = equal with pigment of surrounding skin, 8 = extremely 
      darker than pigment of surrounding skin). The other solar lentigines present in 
      the treatment areas also had to have an overall pigmentation grade of at least 
      Grade 6. Twice daily applications to individual lesions in each treatment area 
      were made for up to 24 weeks followed by a 4-week follow-up phase. Sunscreen 
      applications (sunscreen with sun protection factor (SPF) 25 or greater) were made 
      every morning and reapplied after six hours if additional sun exposure was 
      expected. Clinical evaluations were performed at weeks 0, 4, 8, 16, 24 and 28. 
      The clinical signs of Target Lesion Pigmentation and Overall Lesion Pigmentation 
      were evaluated at each visit. A total of 96 subjects were enrolled at four study 
      centers; 77 (80%) subjects completed the study. Treatment-related adverse events 
      (AEs) for 4HA/tretinoin included erythema, burning/stinging/tingling, 
      desquamation, pruritus, skin irritation, halo hypopigmentation and 
      hypopigmentation. Five (5%) subjects discontinued from the study due to adverse 
      events considered to be related to study medication. When used with sunscreen of 
      SPF 25 or greater, 4HA/tretinoin was safe and well tolerated and did not produce 
      any unexpected or unusual adverse events.
FAU - Colby, S I
AU  - Colby SI
AD  - Bristol-Myers Squibb Pharmaceutical Research Institute, 100 Forest Ave., Buffalo, 
      NY 14213-1091, USA.
FAU - Schwartzel, E H
AU  - Schwartzel EH
FAU - Huber, F J
AU  - Huber FJ
FAU - Highton, A
AU  - Highton A
FAU - Altman, D J
AU  - Altman DJ
FAU - Epinette, W W
AU  - Epinette WW
FAU - Lyon, E
AU  - Lyon E
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Drugs Dermatol
JT  - Journal of drugs in dermatology : JDD
JID - 101160020
RN  - 0 (Anisoles)
RN  - 0 (Sunscreening Agents)
RN  - 5688UTC01R (Tretinoin)
RN  - 6HT8U7K3AM (mequinol)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Anisoles/*therapeutic use
MH  - Drug Therapy, Combination
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Hyperpigmentation/*drug therapy/pathology
MH  - Male
MH  - Middle Aged
MH  - Sunscreening Agents/*therapeutic use
MH  - Tretinoin/*therapeutic use
EDAT- 2003/07/11 05:00
MHDA- 2003/08/07 05:00
CRDT- 2003/07/11 05:00
PHST- 2003/07/11 05:00 [pubmed]
PHST- 2003/08/07 05:00 [medline]
PHST- 2003/07/11 05:00 [entrez]
PST - ppublish
SO  - J Drugs Dermatol. 2003 Apr;2(2):147-52.