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Issue March 2001

Position Papers of the GD
GD Statement
Prescriptions for aesthetic Applications

In accordance with § 5 Arzneimittelgesetz (AMG) [Law governing the Manufacture and Prescription of Drugs] it is prohibited to bring drugs into the market which may be a cause for concern. In the case of the ordinance of questionable drugs, the pharmacist has to refuse dispensing and inform the physician accordingly. Prescriptions are regarded as being questionable if they contain substances which have been assessed in a negative way regarding their benefit-risk relationship. However, if the negative assessment of a substance is based on lacking recognition material or unproved effectiveness without having knowledge of any potential risks, then a dubiousness in the sense of the § 5 AMG does not apply. Prescriptions rated as being questionable are made known after assessment and agreement with the Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) [Federal Institute for Drugs and Medicinal Products] by the Arzneimittelkommission der Deutschen Apotheker (AMK) [Drug Commission of German Pharmacists].

According to latest findings by the AMK, medicinal prescriptions by physicians for uses of aesthetical medicine are made out in an increasing number at present containing the substances testosterone propionate, progesterone, estrogens, cyproterone acetate, canrenoate, dehydroepiandrosterone (DHEA) respectively dehydroepiandrosteronsulphate (DHEAS), androstanolone, nandrolonedecanoate, hydroquinone, trichloracetic acid or phenol. The AMK considers it to be necessary to perform a critical assessment of the prescriptions and asked the GD for a statement in this connection. According to the GD's opinion, the named substances are to be assessed with regard to their use in dermatology as follows:

Testosterone propionate
The use of testosterone propionate in topical preparations for the treatment of the lichen sclerosus et atrophicans has been usual for decades. An effectiveness proof in controlled blind studies has not been performed. Today, considerable doubts about the effectiveness exist, moreover in the individual case unwanted effects in the sense of a local virilization have to be reckoned with specifically with women.

The statements and guidelines of the GD are official position papers of the society. They have been established by the departments or other GD experts and released by the GD's managing committee for publication.

Lately, for the treatment of the disease lichen sclerosus et atrophicans the employment of topical preparations containing clobetasol propionate is especially recommended. Corresponding drugs are regarded as being effective. This is why preparations containing testosterone propionate in the scope of the magistral prescriptions are abstained as a rule today. However, there are no major objections against the application in the isolated case at strict indication especially with male patients.


The use of preparations for topical application containing progesterone is in general not customary in dermatology at present. Known is the local use of a one-percent gel twice a day applied on the breasts in the time of the 10th to 25th cycle day in context of the mamma, the treatment of which is subject of gynecology.


Estrogens are locally applied at the skin and mucous membranes near the skin for the treatment of atrophic mucous membrane changes in the genital area within the post menopause. In principle, systemical effects equally have to be reckoned with in the course of this treatment. In this connection ready-to-use drugs are taken into consideration in the same way as preparations of the magistral prescription.

The usage of estrogens for the female androgenetic alopecia is also taken into account. Undoubtedly proven is the effect of 17-alpha-estradiol, however chemically related to other estrogens, it does not feature the entire spectrum of the estrogenic effects. In connection with the magistral prescription, especially estradiol benzoate solution is considered for the treatment of alopecia (15 mg on 150 ml 70-percent isopropanol; for women).

As further indication of topical estrogens, the skin ageing in the post menopause is taken into consideration, this applies in particular to 0,3-percent estriol creams.

Cyproterone acetate, canrenoate
DHEA respectively DHEAS,
androstanolone, nandrolone decanoate

The use of these substances in the magistral prescription for the treatment of dermatological disases cannot be considered as being customary.


In connection with preparations of the magistral prescription, the use of hydroquinone in concentrations of three to five percent in creams or lipophile ointments as bleaching agent can be considered as being common. Furthermore, hydroquinone is ingredient of a preparation for skin bleaching stated by Kligman which contains additionally vitamine A acid and a glucocorticoid. In the following there is a current prescription in Germany (see box)

0,05 – 0,1
Not indic. emulsific.
ad 100,0

This ointment is applied for the symptomatic treatment of the outlined hyperpigmentation. Although in view of possible local unwanted effects in the sense of an exuberant depigmentation giving rise to considerations as against the use of preparations containing hydroquinone, they are nevertheless considered to be the preparation of choice in connection with the topically medicamentous therapy, whereas the stated combination preparation is given preference compared with mono preparations with hydroquinone.

Indications are likewise acquired hyperpigmentations as melasmae and congenital hyperpigmentations like ephelides. Therapeutic alternatives consist especially in the laser therapy. A ready-to-use remedy with the three active substances listed in the context of the magistral prescription has been approved some time ago in the Federal Republic of Germany.

Trichloracetic acid
Trichloracetic acid is used in dermatology in concentrations of 15 to 50 percent in a watery solution for peeling purposes. In the indications wrinkles, hyperpigmentations and scars, especially also acne scars, the trichloracetic acid peeling is regarded as being superior to the glycol acid peeling. The same is assumed to a certain extent concerning actinic keratoses. A comparatively higher risk concerning scar formation and hyperpigmentation at lacking protection against the exposure of sunlight is considered to be a disadvantage of the application.


Phenol has been an active substance for many decades in a series of dermatologic preparations in particular also of the ones of the magistral prescription. Thus phenolum liquefactum has been an essential ingredient of the solutio castellani listed in the Deutsche Rezeptformeln (DRF) [German Prescription Formulas]. In view of an unfavorable benefit-risk evaluation based on negative monographs regarding phenol, it is no longer used in comparable preparations.

Still discussed is the use for the treatment of proctologic diseases. A five-percent unctuous phenol injection solution (NRF 5.3.) is to be named in this context as an example. However, from an application - at least on a general basis - is to be refrained also in this case. An employment can only be considered for first-degree haemorrhoids; moreover since valid alternatives exist. In recent times the topical use of phenol for peelings is taken into account on a certain scale. In view of the conceivably serious unwanted effects in the sense of the cardiac, hepatic and renal toxicity after absorption a rare application can however, if at all, only be taken into consideration at stationary conditions.


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