ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12622000522718p

Ethics application status

Not yet submitted

Date submitted

20/03/2022

Date registered

1/04/2022

Date last updated

17/04/2023

Date data sharing statement initially provided

1/04/2022

Type of registration

Prospectively registered

Titles & IDs

Public title

Comparison of the efficacy of two triple therapy topical combinations in the treatment of melasma

Scientific title

Comparison of the efficacy of two triple therapy topical combinations in the treatment of melasma in adults

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Melasma

Condition category

Condition code

Skin

Dermatological conditions

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Combination topical therapy of:
1. Thiamidol 100g
2. Retinoic acid 0.05%, 0.1g
3. Dexamethasone acetate 0.1%, 0.1g
Patients will be instructed to apply a pea-sized (approximately 2mL) amount of the combination product across their entire face every night for 12 consecutive weeks. Patients will also be instructed to apply a teaspoon amount of SPF 50 sunscreen 3 times a day for the same treatment period as well as 12 weeks after cessation of the combination therapy while the skin is expected to remain photosensitive due to the residual effects of treatment.
Medication adherence will be evaluated at the end of the 12-week treatment period by assessing the amount of remaining product.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Combination topical therapy of:
1. Hydroquinone 5%, 5g
2. Retinoic acid 0.1%, 0.1g
3. Dexamethasone acetate 0.1%, 0.1g
4. Excipial hydro 100g
This combination is commonly referred to as the 'Kligman's Trio' or 'Kligman's formula' and is the current gold standard treatment for melasma. Patients will be instructed to apply a pea-sized (approximately 2mL) amount of the combination product across their entire face every night for 12 consecutive weeks. Patients will also be instructed to apply a teaspoon amount of SPF 50 sunscreen 3 times a day for the same treatment period as well as 12 weeks after cessation of the combination therapy while the skin is expected to remain photosensitive due to the residual effects of treatment.
Medication adherence will be evaluated at the end of the 12-week treatment period by assessing the amount of remaining product.

Control group

Active

Outcomes

Primary outcome [1]

Treatment efficacy, measured using the modified melasma area and severity index (mMASI) score.

Timepoint [1]

Assessed after 12 weeks of treatment (week 12) and 12 weeks after treatment cessation (week 24), comparing to mMASI score at baseline (measured at week 0).

Secondary outcome [1]

Tolerance, as assessed using a visual scale ranging from 0 to 10 quantifying the degree of erythema, dry skin, irritation and flaking. The component scores will be assessed as a composite outcome.

Timepoint [1]

Assessed after 12 weeks of treatment (week 12) and 12 weeks after treatment cessation (week 24).

Secondary outcome [2]

Effectiveness, measured by colorimetric evaluation of skin pigmentation changes in lesional and perilesional skin. A mexameter will be used for this.

Timepoint [2]

Assessed after 12 weeks of treatment (week 12), and 12 weeks after cessation of treatment (week 24), comparing to colorimetry score at baseline (measured at week 0).

Secondary outcome [3]

Quality of life, as assessed using the Melasma Quality of Life (MELASQOL) self-questionnaire.

Timepoint [3]

Assessed after 12 weeks of treatment (week 12), and 12 weeks after cessation of treatment (week 24), comparing to MELASQOL score at baseline (measured at week 0).

Secondary outcome [4]

Overall patient perception of products, as evaluated through the question "have the products you have used to improve your melasma reduced its severity" with a 5-point Likert scale answer option ranging from strongly agree to strongly disagree.

Timepoint [4]

Assessed after 12 weeks of treatment (week 12).

Eligibility

Key inclusion criteria

- Patient clinically diagnosed with melasma
- If patient is of childbearing age, she will be required to use a reliable contraceptive for at least 1 month and agree not to change her contraceptive status for the duration of the study
- Patient who has signed the written informed consent form for study participation

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

- Women who are pregnant or breast-feeding or who are planning for pregnancy during the course of the study. (A urine b-HCG or urine dipstick test will be performed)
- Patient with another pigmentation disorder on the face.
- Patient with other dermatoses that may interfere with the evaluation or application of the products involved in the study.
- Patient who has used a depigmentation agent in the month prior to inclusion.
- Patient who has used a local corticosteroid on the skin, eyes, nose or mouth (inhaled corticosteroid) or systemic corticosteroids during the month prior to inclusion.
- Patient who has used local tretinoin or hydroquinone in the month prior to inclusion.
- Patient on chronic anti-inflammatory therapies (patient accepted into study if cumulative NSAID use is less than 10 days over the duration of the study).
- Patient with a clinically significant history of allergy, especially to the components of the products studied.
- Vulnerable persons including people under the age of 18 and those who are unable to take care of or protect themselves against harm or exploitation.
- Patient being in a situation that, in the investigator's opinion, may interfere with optimal participation in the study.
- Patient who is participating or has participated in another clinical drug trial in the month prior to inclusion.
- Patient who cannot communicate effectively with the investigator or who cannot follow the instructions involved in the study.
- Patient who is refusing to be photographed as part of the study.
- Patient who withdraws their informed consent from the study.

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Allocation will take place at the off-site Atara compounding pharmacy.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple randomisation using a randomisation table created by computer software.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Phase 1

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/08/2023

Actual

Date of last participant enrolment

Anticipated

1/10/2023

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Michelle Rodrigues

Address [1]

Chroma Dermatology: Ground Floor, suite 15/202 Jells Rd, Wheelers Hill VIC 3150

Country [1]

Australia

Primary sponsor type

Individual

Name

Michelle Rodrigues

Address

Chroma Dermatology: Ground Floor, suite 15/202 Jells Rd, Wheelers Hill VIC 3150

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

Bellberry Limited

Ethics committee address [1]

123 Glen Osmond Road Eastwood Adelaide
South Australia 5063

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

10/01/2022

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

Melasma is a common disorder of hyperpigmentation, primarily affecting the face. It can affect all racial types but predominately affects women with darker skin types.

The exact cause of melasma is unknown, but it is thought to be due to many things including pregnancy, hormonal contraception, and sunlight.  Melasma can be very difficult to treat and often frustrating for the patient and doctor with evidence showing that it may adversely affect quality of life. 

The standard topical treatment for melasma that has been used since the 1970’s, is a combination agent including hydroquinone 5%, retinoic acid 0.1% and dexamethasone acetate 0.1% (commonly called “Kligman’s Trio”). Although this treatment is effective, it frequently causes skin irritation, and the hydroquinone is largely responsible for this. Hydroquinone also carries a risk of causing skin discolouration with long-term use. 

Thiamidol, like hydroquinone, is a depigmentation agent. Recent studies showed that thiamidol was better than hydroquinone in treating melasma while causing fewer side effects (Arrowitz et al, Journal of Investigative Dermatology, 2019). Replacing hydroquinone with thiamidol in this readily prescribed depigmentation formula has never been studied.  

Therefore, this study aims to determine if topical thiamidol + retinoic acid + dexamethasone acetate combination treats melasma as well as the standard Kligman's Trio.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Michelle Rodrigues

Address

Chroma Dermatology: Ground Floor, suite 15/202 Jells Rd, Wheelers Hill VIC 3150

Country

Australia

Phone

+61 3 85606946

Fax

dr.rodrigues@gmail.com

Contact person for public queries

Name

Michelle Rodrigues

Address

Chroma Dermatology: Ground Floor, suite 15/202 Jells Rd, Wheelers Hill VIC 3150

Country

Australia

Phone

+61 3 85606946

Fax

dr.rodrigues@gmail.com

Contact person for scientific queries

Name

Michelle Rodrigues

Address

Chroma Dermatology: Ground Floor, suite 15/202 Jells Rd, Wheelers Hill VIC 3150

Country

Australia

Phone

+61 3 85606946

Fax

dr.rodrigues@gmail.com

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
15448	Study protocol					383452-(Uploaded-17-03-2022-00-13-37)-Study-related document.docx
15449	Informed consent form					383452-(Uploaded-17-03-2022-00-13-50)-Study-related document.docx

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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