Glycollic acid

Exposure related observations in humans: other data

Administrative data

Endpoint:

exposure-related observations in humans: other data

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

Not stated

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Well-documented double-blind vehicle-controlled clinical study; Not standard guideline, but uses good scienitific principles; No mention of GCP/GLP guidelines but subjects did sign an informed consent prior to study initiation; No analytical confirmation of test material reported

Data source

Reference

Reference Type:

publication

Title:

Clinical Improvement of Photoaged Skin with 50% Glycolic Acid

Author:

N. Newman, A. Newman, L.S. Moy, R. Babapour, A.G. Harris, R.L. Moy.

Year:

1996

Bibliographic source:

American Society for Dermatologic Surgery, 22: 455-460

Materials and methods

Type of study / information:

Clinical study for photoageing in human skin

Endpoint addressed:

not applicable

Principles of method if other than guideline:

The purpose of the study was to determine whether 50% glycolic acid can improve photoaged skin and to study the histological basis for improvement

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Glycollic acid

EC Number:

201-180-5

EC Name:

Glycollic acid

Cas Number:

79-14-1

Molecular formula:

C2H4O3

IUPAC Name:

2-hydroxyacetic acid

Details on test material:

Glycolic acid 50%

Method

Details on study design:

Forty-one volunteers were recruited into this doubleblind vehicle-controlled study. Glycolic acid (50%) or vehicle
was applied topically for 5 minutes to one side of the face, forearms, and hands, once weekly for 4 weeks. Punch biopsies
were taken at pretherapy and at 5 weeks for histologic study.

Results and discussion

Results:

Significant improvement noted included decrease in rough texture and fine wrinkling, fewer solar keratoses, and a
slight lightening of solar lentigines. Histology showed thinning of the stratum corneum, granular layer enhancement, and epidermal
thickening. Some specimens showed an increase in collagen thickness in the dermis.

Applicant's summary and conclusion

Conclusions:

The results of this study demonstrate that the application of 50% glycolic acid peels improves mild photoaging of the skin

Executive summary:

The purpose of this study was to determine whether 50% glycolic acid can improve photoaged skin and to study the histological basis for this improvement. Forty-one volunteers were recruited into this doubleblind vehicle-controlled study. Glycolic acid (50%) or vehicle was applied topically for 5 minutes to one side of the face, forearms, and hands, once weekly for 4 weeks. Punch biopsies were taken at pretherapy and at 5 weeks for histologic study.

Significant improvement noted included decrease in rough texture and fine wrinkling, fewer solar keratoses, and a slight lightening of solar lentigines. Histology showed thinning of the stratum corneum, granular layer enhancement, and epidermal thickening. Some specimens showed an increase in collagen thickness in the dermis.

The results of this study demonstrate that the application of 50% glycolic acid peels improves mild photoaging of the skin.